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NutraceuticalsNow

LATEST TECHNOLOGY • LATEST TECHNOLOGY • LATEST TECHNOLOGY • LATEST

Autumn 2014

Probiotics - an overview

The value of Chitosan

Healthful ingredients that address the major health concerns of aging consumers

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“Probiotics are more important thanMultivitamins and should be taken daily”™

Dr. S.K.DashDD Innovations

[email protected]

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contents

Nutraceuticals Now is a technical review providing the latest information on functional products and ingredients which are defined as having a disease preventing and/or health promoting benefit in addition to their nutritional value.It is targeted at manufacturers of food and drink, who are producing finished products aimed at the ever increasingly health conscious consumer.Any views and/or opinions expressed in the articles in this magazine are entirely those of the individual authors and do not necessarily express the views of the editorial staff.

ISSN -1478-6605

Editor: Charles FaulknerOperations Manager: Dan PeacockAccounts: Steve ClarkDesigner: Al Knight

Published by: Johnson-Johnsen Publishing 6 Victoria Terrace, Inverness, IV2 3QA, Scotland.Tel: +44(0) 1463 718993Fax: +44(0) 1463 229976Email: [email protected]: www.nutraceuticalsnow.com

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advertisers02 Neptune03 UAS Labs05 Hi Japan06 Supply Side West13 Natural Organics15 NSF21 Bionap22 Primex28 OmniActive33 Allied Biotech34 Sabinsa35 Aker Biomarine

07-09 Foreword09 Fytexia company news10-12 Proibotics - an overview14 Training for a culture of quality16-17 More quality of life, healthy aging with Ubiquinol18 Clean labels19-21 Forging ahead in Omega-3 market23-25 The value of Chitosan as a dietary fiber26-28 Macular Carotenoids - natural antioxidants for a lifetime of healthy vision29-30 Careless® - the innovation of well aging31-33 Healthful ingredients that address the major health concerns of aging consumers35 Neptune introduces football frenzy, krill oil formulas and new sales director at Supply Side Werst

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Neptune Introduces Football Frenzy, Krill Oil Formulas, and New Sales Director at SupplySide West


Health is important to consumersEuromonitor International health and wellness data shows not only that the global nutraceuticals market is enormous in size, but that its growth is continuing at a steady pace, largely unfettered by recessionary pressures. In 2013, retail value sales of vitamins and dietary supplement reached US$84.5 billion worldwide, up from US$62.5 billion in 2008 (based on fixed 2013 US$ exchange rates), while fortified/functional packaged food and beverages amassed a staggering US$263.6 billion, representing a 41% increase on 2008 sales.

Considering the impact of the 2008 financial crisis, which brought economic growth to a grinding halt in many of the world’s foremost consumer markets, such growth rates are no small feat and attest to the fact that consumers are more than willing to dedicate some of their disposable income to their personal health and wellness goals.

Key positioning platformsSo, what are consumers’ main health and wellness concerns? Euromonitor International has identified 14 prime positioning platforms on which health and wellness packaged food and beverages are marketed, as shown in the figure below.

Of course, it is not just products with added functional ingredients that are leveraged on these positioning platforms, but also naturally healthy products, such as oat-based breakfast cereals promoted as heart healthy.

Food and beverages marketed as exerting specific physiological effects are selling as well as ever. Not even a worldwide recession has managed to stifle the popularity of these (usually) premium-priced products. Global business intelligence provider Euromonitor International gives an overview of the global nutraceuticals market, and examines which positioning platforms are the most popular for fortified/functional food and beverages.

Nutraceuticals: which are the top-selling health benefits?

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get exploring

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There’s so much going on in the Expo Hall this year, you’ll have to pace yourself!There are 1,700+ booths … nearly 50 exhibitors offering free tastings … live debates,

compliance briefi ng and documentaries. There’s even a stress-relief center. Discover contract manufacturers … ingredient suppliers … lab testing fi rms … equipment companies … supply chain and packaging experts … from around the world –– ready to answer your

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Regardless of your business focus, you’ll fi nd dozens of opportunities to exchange ideas and share information with peers and experts. Come with questions. Leave with answers.

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Health and wellness by Prime Positioning, Global Retail Sales (US$ billion) 2013

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Predictably, after general wellbeing, weight management is the most popular positioning platform, accounting for one fifth of health and wellness food and beverage value sales in 2013. In terms of growth, though, the category’s performance has been a tad on the sluggish side, achieving a CAGR of just 4% over the 2008-2013 review period.

This is certainly not because consumers are no longer keen on keeping their weight in check, but they are slowly losing their enthusiasm for conventional slimming products, such as calorie-counted ready meals and meal replacement slimming products, including shakes, and bars. Instead, slimmers are staying away from carbs, and are veering towards high protein products, which are not overtly marketed as weight management products, but are widely believed to afford longer-lasting satiety.

To a not insignificant extent, the boom in food intolerance products, which clocked up more than double the value growth rate of weight management products over 2008-2013, also has some relevance here, as many consumers blame their excess pounds on food sensitivities, even if the presence of an allergy or an intolerance cannot be diagnosed via conventional medical routes.

Energy boosting enjoys fastest growthHuman nature loves nothing more than a quick fix, which is why the most dynamic positioning platform over the review period was energy boosting, seizing an 11% CAGR over 2008-2013, equating to a 71% value sales increase overall. Needless to say, the bulk (almost 90%) of these sales came from energy drinks.

There is now a move towards ‘natural’ or ‘clean’ energy, which fits in with the global trend towards products labelled ‘natural’, although a legal definition for this designation has not yet been established. Examples of such products include EQ8 Natural Energy and Runa Clean Energy.

The former, by EQ8 Limited, is sweetened with steviol glycosides and promises to provide one of the five recommended daily fruit and vegetable portions a day. It is available from virtually all mainstream retailers in the UK. Runa LLC, a New-York-based company founded by two young entrepreneurs in 2009, boasts a short ingredients list – an attribute much favoured by consumers keen to avoid “overprocessed” products. For its energy-boosting properties, the product employs the guayusa leaf, sourced from Ecuador. Up until now, maté and guarana, which

also originate from South America, are the most common natural alternatives to the (synthetic) caffeine found in the majority of energy drinks, and we expect to see plenty of new product development activity on the ‘natural energy’ front in future.

Beauty from within: A tricky concept to sell Beauty from within remains a comparatively small positioning platform for health and wellness food and beverages. It accrued global value sales of US$358 million in 2013, which is modest when compared to the US$31 billion achieved by energy boosting, and the even more staggering US$156 billion amassed by weight management products. Even the urinary tract health category mustered more than double the sales realised by beauty from within in the same year.

The primary problem for the category is 2-fold: these products do not give immediate results, but, unlike cardiovascular health-positioned products, which also tend to rely on cumulative long-term effects, beauty from within products tend to lack a solid scientific evidence base affirming their efficacy. This partly explains why sales in North America have thus far remained fairly negligible. In Asia Pacific, on the other hand, these products enjoy a much stronger cultural acceptance (particularly in Japan, South Korea, Thailand and Malaysia), and 41% of category value sales were generated in this region in 2013.

However, because of its still rather modest sales base, and also due to the Asia Pacific region being a huge market in terms of population numbers, Euromonitor International predicts that, over the 2013-2018 forecast period, beauty from within will garner the second highest value growth rate of 30% at constant 2013 prices, behind energy boosting’s 40% rise. Food intolerance products are envisaged to see almost the same percentage growth gain as beauty from within, followed very closely by digestive health.

What is abundantly clear is that nutraceuticals, which were once dismissed as a “fad”, are becoming ever more relevant to consumers, both in terms of helping them manage serious health concerns, such as cardiovascular disease and obesity, as well as in the “feel good” realm, as evidenced by the proliferation of energy boosting, digestive health and beauty from with in products. Also, the fact that functional foods and beverages have emerged as virtually recession proof should encourage manufacturers to continue investing in NPD.

By Simone Baroke, Contributing Analyst at Euromonitor International

company news . .company news . . compa-Fiit-ns® by Fytexia® – explore Mediterranean health Metabolic Anti-Aging - Publication of a new

clinical study.French natural ingredient manufacturer Fytexia® announces the publication of the first clinical study

carried out on Fiit-ns®, its proprietary Metabolic Anti-Aging Ingredient.Fiit-ns® is a synergistic blend of extracts from grapefruit, grape, green tea, guarana and black carrot, bringing strong antioxidant properties from various polyphenols. It is enhanced with vitamin B3 to increase the feeling of energy while reducing tiredness linked to active lifestyles.

Fiit-ns® offers benefits from the synergy between polyphenols to rejuvenate body parameters, for a metabolic anti-aging action and thus an improvement of quality of life (QOL).

A 12-week randomized, double-blind, placebo-controlled clinical study has been conducted on 17 obese subjects (BMI=30-33.3). They received either 0.9g/day of Fiit-ns® (2x450mg) or a placebo and had a normal diet & 30min/week of physical activity.

After 12 weeks, metabolic markers have been improved, leading to a significant improvement of QOL.• Higher feeling of energy in the Fiit-ns® group.• Higher feeling of well-being in the Fiit-ns® group.• Weight loss of -6.1kg (p<0.005) in the Fiit-ns® group associated with more importantreductions of waist size and hip size than in the placebo group.• Metabolic functions, such as cardiovascular parameters, glycated hemoglobin,oxidative stress, etc, significantly improved in the Fiit-ns® group.

With the publication of this clinical study in the International Journal of Food Sciences and Nutrition, Fytexia® demonstrates that Fiit-ns® delivers benefits from the synergistic combination of selected fruit & vegetable extracts and vitamin B3 to improve QOL based on the rejuvenation of metabolic functions.

To know more about Fiit-ns®, reach us at [email protected] or visit us on booth #18147 at Supply Side West.

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Probiotic dairy yogurt has been one of the fastest growing food products worldwide in terms of sales and it has gained popularity worldwide, largely due to its functionality, good taste and health benefits. The leading probiotic Yogurt brands and their percentage of market shares in 2013 are illustrated in Figure 2. Non-dairy probiotic products are also gaining interest among consumers in the USA because of their low cholesterol content. In USA, companies like DuPont, Chris Hansen, General Mills, Lifeway Foods Inc. and UAS Laboratories, LLC. are the market leaders in terms of supply of probiotic foods and supplements, and they exhibit potential growth in probiotics market over functional foods (Global Industry Analysts, Inc., 2014).

In European countries, the tradition of consumption of fermented milk is popular and within Europe, Germany and the UK account for about 45% of the total market. The probiotic consumer market in Western Europe is about €11.4 billion. Yogurt and Desserts, with sales of approximate €1 billion comprises the biggest sector whereas probiotic milk products shares the major part and is forecast to grow annually at approximate 7–8% over the next five years (Sharma et al., 2013). In United States of America, probiotics markets are set for rapid growth in coming years, despite extensive consumer ignorance about what probiotics are and how they can benefit the human body. Currently, USA is the fastest growing and most rapidly expanding functional food and nutraceutical market in the world. It is estimated that the USA market will reach $3.5 billion by 2016 from its current level of $800 million. The markets of North America and emerging countries such as Brazil also show great potential for growth (Frost and Sullivan report, 2013). In Asia-Pacific, China and Japan, dominate the market revenue for probiotics. India and other parts of Asia also show significant growth. In India, probiotic market was valued at $2 million as per 2010 estimates and revenues of India’s Dairy and Probiotic market is expected to grow at the CAGR of around 5% during 2012-17. According to Frost and Sullivan report, in August 2012, probiotic products in India generated revenue of $310 million in 2011. The market share is expected to increase to $522.8 million by 2018. Currently Milk and fermented milk products share 62% of the market value in probiotic products (Sharma et al., 2013). The probiotics market has been one of the prime beneficiaries of the recent fad over functional foods. Public health consciousness and aging baby boomer population are the drivers helping the growth of the market. This gathers more importance considering the fact that the probiotic food and beverages segment accounted for over 84% of the overall probiotics market in 2014. Asia-Pacific and Europe dominate the global market in terms of demand, while Asia-Pacific is also expecting to have greater market share.

Potential clinical applications of ProbioticsAt present, consumers are aware of the relations among lifestyle, diet and good health, This explains the emerging demand for products that are able to enhance health beyond providing basic nutrition. Probiotics are the live microorganisms which, when administered in adequate amounts, confer a health benefit on the host by improving intestinal microbial balance. Therapeutically, probiotics are used in some countries for several conditions such as acute diarrhea in children, antibiotic associated diarrhea, traveler’s diarrhea, constipation, urogenital diseases including candidal vaginitis and urinary tract infections, immune disorders, lactose intolerance, hypercholesterolaemia,

colon and bladder cancer, osteoporosis and food allergy (Mombelli and Gismondo, 2000; Kopp-Hoolihan, 2001; Lourens-Hattingh and Viljoen, 2001; Rao et al., 2007). Lactic acid producing bacteria confer a range of health benefits including immune system modulation, increased resistance to malignancy and infectious diseases (Soccol et al., 2010; Thakur et al., 2014). Host immune modulation is one of the recommended benefits of the consumption of probiotic functional food and supplementation of the diet with probiotics strains (Bifidobacterium longum, Bifidobacterium lactis, Lactobacillus rhamnosus and Lactobacillus acidophilus) was able to enhance several indices of natural and acquired immunity. Infectious diseases are still the biggest human health challenges for the world to solve. Gastro-intestinal infections caused by the intake-contaminated water and food that contains pathogenic microorganisms are the primary causes of death. Several studies demonstrated that probiotics strains Bifidobacterium lactis and Lactobacillus acidophilus can significantly prevent the food borne infectious conditions (Soccol et al., 2010; Seifert and Watzl, 2008).

Probiotic strain Lactobacillus GG, either as a supplement or in fermented milk is used in the management of acute pediatric diarrheal disease in which Lactobacillus GG was added to an oral rehydration solution and given to children during a diarrheal episode. Lactobacillus GG was found to be effective in the prevention of traveler’s diarrhea. Antibiotics can severely disrupt gut microbial ecology. Ingestion of probiotic strains (Enterococcus faecium, Lactobacillus GG, Lactobacillus acidophilus, Lactobacillus bulgaricus and S. boulardii) following antibiotic therapy can reduce the effect of such microbial alteration and any resulting changes in stool consistency and frequency. Certain probiotics may be helpful as adjuvant therapy with antibiotics in the eradication of H. pylori infection (Saavedra, 2001).

Several studies also demonstrated possible anti-carcinogenic effect of probiotics with carcinoma cell lines. The anti-carcinogenic effect may be attributable to a combination of mechanisms such as the induction of pro-inflammatory, anti-inflammatory or secretary responses that might inhibit carcinogenesis (Soccol et al., 2010). The application of probiotics to prevent allergic reactions became more prominent where L. rhamnosus GG when given to pregnant women for 4 weeks prior to delivery and then to newborn children at high risk of allergy for 6 months caused a significant reduction in early atopic disease. L. rhamnosus GG and B. lactis BB-12 also useful in infants allergic to cow’s milk (Saavedra, 2001).

Probiotics have been recommended to consumers with pouchitis of mild activity or as maintenance. The probiotic strain Escherichia coli Nissle strain appears to be equivalent to Mesalazine in maintaining remission of ulcerative colitis. Probiotics have been effective in inducing and maintaining remission in children and adults with mild-to-moderate ulcerative colitis. Probiotic strains B. Infantis in addition Lactobacillus reuteri may improve colicky symptoms within one week of supplementation (Saavedra, 2001). The ingestion of dairy products containing lactose leads to signs and symptoms of lactose intolerance, e.g., increased abnormal gas, bloating, flatus, abdominal pain and diarrhea. Streptococcus thermophilus and L. delbrueckii subsp. bulgaricus improve lactose digestion and reduce symptoms related to lactose intolerance. This was confirmed in a number of controlled studies with individuals

Figure 2: Leading probiotic Yogurt brands and their % global market share in 2013, (Global Industry Analysts, Inc., 2014).

Probiotics . . . an overview Probiotics are friendly bacteria. When consumed, probiotics confer beneficial effects to the host. It influences the homeostasis and controls various gastrointestinal disorders (Heyman, 2000). In the gastrointestinal tract, about 100 trillion bacteria are present, which help to maintain good health. Probiotic ingestion can be a preventive approach for maintaining the balance of the intestinal microbial flora. Over 2000 years ago, the first use of fermented foods and cultured milk predates recorded history (Rao et al., 2007). However, in 1908 Russian scientist Eli Metchnikoff first proposed the concept of probiotics, where he observed that human health and longevity are associated with the ingestion of lactic acid producing bacteria (Metchnikoff, 2004; NASPGHAN Nutrition Report Committee, 2006). In 1935, a Japanese scientist Minoru Shirota developed a fermented milk product called Yakult, the first probiotic beverage for the Japanese market that contain Bifidobacterium breve bacteria. After its introduction in Japan and Taiwan, Yakult was first sold in Brazil in 1966. Today, Yakult is consumed in 31 countries. DDS® Probiotics in supplement forms are consumed in 55 countries. Probiotics confer a wide range of health benefits and because of its increased familiarity expansion of research, the market value of probiotics increased sharply in the past decade (Sharma et al., 2013). Probiotics have been used to boost immunity, lower blood cholesterol, treat diseases like athereosclerosis, rheumatoid arthritis, cancer, Helicobacter pylori infections, diarrhea and constipation, urinary tract infections, improve lactose intolerance, and prevent or reduce the effects of atopic dermatitis and candidiasis (Kumar et al., 2012; Sharma et al., 2013; Parvez et al., 2006; Dash, 2006). Currently, probiotic foods, dietary supplements and beverages are accepted globally due to development in the relationship between nutrition and health, their promising health benefits and negligible side effects. Increased health awareness and commercial interest in developing the proposed health benefiting features of probiotics has contributed extensively to the growth and expansion of this market sector. The future market of probiotics is promising as consumers are ready to consider nutrition, supplements such as probiotics, and exercise as an option to maintain good health.

History of ProbioticsThroughout human civilization, people have extensively used fermented foods and cultured dairy products; they are even mentioned in the Bible and the sacred books of Hinduism. Climatic conditions and lifestyle favored the development of many of the traditional soured milk or cultured dairy products, which contained beneficial microorganisms (Hosono, 1992). These cultured dairy products had often been used to support health before the existence of bacteria was recognized (Soccol et al., 2010). At the beginning of the 20th century, Russian Nobel Prize winner Eli Metchnikoff of Pasteur Institute proposed the link of health and longevity to ingestion of bacteria present in yogurt (Metchnikoff, 2004; NASPGHAN Nutrition Report Committee, 2006). In 1907, he observed that the bacteria in yogurt involved fermentation like Lactobacillus bulgaricus and Streptococcus thermophilus, and prevented the decaying-type fermentations of the intestinal micro flora and that consumption of these yogurts played a role in maintaining health and longevity. He theorized that the lactic acid bacteria conferred a type of protection from, or reversal of, the intestinal autointoxication. Indeed, he mentioned the long life of Bulgarian people, because they had an average lifespan much greater than Europeans and he noted that, this because of their intake of foods containing lactic acid producing bacteria (Soccol et al., 2010). He concluded that the lactic acid bacteria associated with fermented milk products yogurt had anti-aging health benefits and he named the organism “Lactobacillus bulgarius” (Metchnikoff, 2004).

In 1920, Professor Leo F. Rettger observed that Lactobacillus bulgarius could not survive in the intestine, and was destroyed by stomach acid. However, he demonstrated that many other

bacteria strains, which normally present in the intestine, could be useful as probiotics, helping to restore normal bacterial colonization when introduced into the human digestive tract. One of such bacteria, Lactobacillus acidophilus, has been shown to correct constipation (Hoffman and Hiembach, 2008).

In 1935, a Japanese scientist Minoru Shirota developed fermented milk, which contained Lactobacillus strains that could survive passage through the intestine and also in stomach acid, and distributed it to the consumer. Shirota’s first product, containing Lactobacillus acidophilus, was the basis for the establishment of the product and subsequently the Yakult Honsha Company. After its introduction in Japan and Taiwan, Yakult was first sold in Brazil in 1966 and today, Yakult is sold in 31 countries (Yakult Central Institute for Microbiological Research, 1998). In 1979, probiotics were reintroduced in USA by Dash, founder of UAS Laboratories. UAS Laboratories has a line of probiotic supplements developed by Dash, which are now sold in 55 countries (Dash, 2006).

The term “Probiotic” originally referred to microorganisms that promote growth of other microorganisms, coined in 1965 by Lilly and Stillwell. The characteristics, actions, effects and importance of probiotics have a renewed popularity in contemporary culture, but probiotics are ancient history. Thousands of years ago, a Roman naturalist named Pliney recommended drinking fermented milk to correct intestinal problems. This demonstrated the health benefits of probiotics in past. Many of the same soured milk products are still being consumed today.

Market potential for probiotic productsProbiotics are fast growing nutraceuticals. Probiotics are now available in foods, beverages and dietary supplements. The global probiotics market, still in its infancy stage, is set to witness extraordinary growth as people become more conscious about their health and switch to preventative healthcare due to rising healthcare cost (Sharma et al., 2013). As per the market survey report by Global Industry Analysts, Inc., Europe and Japan are the market leaders in terms of use of probiotic dairy products that are useful for gut health. Probiotics market in United States of America is demonstrating signs of maturity; the market is focused on digestive health and immune function among other health conditions.

According to the report, the global market for probiotic products has reached nearly US$27.1 billion in 2013, and is likely to grow to nearly US$41.3 billion by 2020 with a compound annual growth rate (CAGR) of 8.4% over the seven-year period from 2013 to 2020 (Figure 1). In 2013-14, Japan shares an estimated 34.2% of total global sales and represents the single largest regional market for probiotics worldwide. The regional market for probiotics in Asia-pacific is projected to grow with a CAGR of 7.0% from 2013 to 2020 (Global Industry Analysts, Inc., 2014).

Figure 1: Forecast of global market revenue for probiotic products.

By Dr. Vikas Kumar , Associate Professor of Pharmacology, Neuropharmacology Research Laboratory, Department of Pharmaceutics, Indian Institute of Technology (BHU), Varanasi-221 005, Uttar Pradesh, India


consuming yogurt with live cultures (Saavedra, 2001).Bacterial vaginosis increases the risk of preterm labour and

infant mortality. Probiotics decrease the risk of bacterial vaginosis and maintain normal Lactobacilli vaginal flora. Randomized, placebo-controlled trial indicates that daily oral intake of L. rhamnosus GR-1 and L. fermentum RC-14 leads to transfer of the organisms from the rectum to the vagina as well as an overall depletion of coliforms and yeasts in the vagina. The urinary tract infection was prevented by once-weekly vaginal application of a suppository containing L. rhamnosus GR-1 and L. fermentum B-54 for 1 year (Mombelli and Gismondo, 2000; Kopp-Hoolihan, 2001; Lourens-Hattingh and Viljoen, 2001).

Probiotics are also used in cosmetics as bioactive ingredient to keep the skin healthy. Probiotic strains and their secretions to the sebaceous glands help to maintain the acid balance of the skin, thus reduces the skin ageing.

Side Effects of ProbioticsIn rare cases, probiotics cause bloating, diarrhea and abdominal pain. Consumers having an underlying disease or compromised immune system may have potential health problems like skin rash, fever, bloody stools etc. Sometimes probiotics interact with immunosupressive drugs leading to life threatening conditions, therefore concomitant use of probiotics and immunosuppressive drugs should be avoided (Soccol et al., 2010).

Regulatory aspects of the use of probioticsThe Joint FAO/WHO Expert Consultation on Evaluation of Health and Nutritional Properties of Probiotics in Food held in Cordoba, Argentina from 1-4 October 2001 documented that there is a requirement for guidelines to set out a systematic approach for the evaluation of probiotics in food leading to the justification of health claims. Consequently, a Working Group was constituted by FAO/WHO to generate guidelines and recommend criteria and methodology for the evaluation of probiotics, and to identify and define what data need to be available to accurately justify the health claims. The aims of the Working Group were to identify and outline the minimum requirements needed for probiotic status. Consequently, guidelines were prepared to meet this objective (Khan and Ansari, 2007).

Regulatory requirements for the use of probiotic products differ depending on the proposed use of a probiotic, whether as a drug or a dietary supplement. If a probiotic is intended for use as a drug, then it must follow the regulatory process as a drug, which is similar to that of any new therapeutic agent. An Investigational New Drug application must be submitted and authorized by FDA before an investigational or biological product can be administered to humans. The probiotic drug must be proven safe and effective for its intended use before marketing (Venugopalan et al., 2010).

If a probiotic is intended for use as a dietary supplement, then it is regulated by FDA’s Center for Food Safety and Applied Nutrition. Unlike drugs, dietary supplements do not need FDA approval before being marketed. However, it is manufacturer responsibility to notify FDA before marketing a product. According to Dietary Supplement Health and Education Act (DSHEA), the manufacturer is responsible for product safety, and states that any representations or claims made about products are authenticated by sufficient proof to show that they are not false or misleading. The manufacturers need not provide FDA with evidence that authenticates the safety or benefits of their products, either before or after marketing (Venugopalan et al., 2010).

In India probiotics are categorized under functional food and currently regulated by food laws that regulate general food items rather than pharmaceuticals or drugs. In India, Prevention of Food Adulteration Act (PFA) and Food and Drug Administration (FDA) regulate probiotics food and drugs respectively. The Food Safety and Standards Act (FSSA), 2005 was formed to consider as a single regulatory body that regulate food law in India (Sharma et al., 2013).

Previously no such regulatory guidelines and systematic approach was made for probiotic products. Therefore, an approach was evolved for formulating guidelines and regulations for evaluating the safety and efficacy of probiotics in India. In this context, Indian Council of Medical Research (ICMR) and Department of Biotechnology (DBT), comprising of experts from varied fields to frame regulatory guidelines for evaluation of

probiotics food in India (Sharma et al., 2013), constituted a joint committee.

ConclusionThe popularity of probiotics has been increasing significantly during the recent years. Its sales as dietary supplements, medical foods and drugs have been increasing from an estimated $10 million in 1979 to $31 billion in 2014. This extensive market growth will continue to keep probiotic products under regulatory radar.

ReferencesDash, S.K., 2006. The Consumer’s Guide to Probiotics: How Nature’s Friendly Bacteria Can Restore Your Body to Super Health. First edition/second printing. Freedom Press, Topanga, CA, USA.

Frost & Sullivan report. 2013. Analysis of the Probiotics and Enzymes Market.

Global Industry Analysts, Inc. 2014. Probiotics - A Global Strategic Business Report.

Heyman, M., 2000. Effect of Lactic acid bacteria on diarrheal diseases. Journal of the American College of Nutrition 19, 137-146.

Hoffman, F.A., Hiembach, J.T., 2008. Executive summary: scientific and regulatory challenges of development of probiotics as foods and drugs. Clinical Infectious Diseases 46, 553-557.

Hosono A., 1992. Fermented Milk in the Orient. In: Functions of Fermented Milk: Challenges for the Health Sciences. Nagasawa, Y., Hosono A., Elsevier Applied Science. London. UK. 61-78.

Khan, S.H., Ansari, F.A., 2007. Probiotics – the friendly bacteria with market potential in global market. Pakistan Journal of Pharmaceutical Sciences 20, 71-76.

Kopp-Hoolihan, L., 2001. Prophylactic and therapeutic uses of probiotics: a review. Journal of the American Dietetic Association 101, 229-238.

Kumar, M., Kumar, R., Poovai, P.D., Kalaichelvan, P.T., 2012. Probiotics and multitude of health benefits. Journal of Research in Biology 2, 102-113.

Lourens-Hattingh, A., Viljoen, B.C., 2001. Yogurt as probiotic carrier food, International Dairy Journal 11, 1–17.

Metchnikoff, I.I., 2004. The Prolongation of Life: Optimistic Studies. Springer Publishing Company. New York. USA.

Mombelli, B., Gismondo, M.R., 2000 The use of probiotics in medical practice. International Journal of Antimicrobial Agents 16, 531-536.

NASPGHAN Nutrition Report Committee, Michail, S., Sylvester, F., Fuchs, G., Issenman, R., 2006. Clinical efficacy of probiotics: review of the evidence with focus on children. Journal of Pediatric Gastroenterology & Nutrition 43, 550-557.

Parvez, S., Malik, K.A., Kang, A.H., Kim, H.Y., 2006. Probiotics and their fermented food products are beneficial for health. Journal of Applied Microbiology 100, 1171-1185.

Rao, C.V., Vijayakumar, M., Verma A.R., Kumar V., 2007. Dietary Components as Prebiotic/Probiotic(s) in Human Health Diseases. The Pharma Review, 101-105.

Saavedra, J.M., 2001. Clinical applications of probiotic agents. American Journal of Clinical Nutrition 73, 1147S–1151S.

Seifert, S., Watzl B., 2008. Prebiotics and the Immune System: Review of Experimental and Human Data. In: Gibson, G.R., Roberfroid M., Handbook of Prebiotics. CRC Press. Taylor & Francis Group. USA. 143-157.

Sharma S., Arora, M., Baldi, A., 2013. Probiotics in India: current status and future prospects. PharmAspire, 1-11.

Soccol, C.R., de Souza Vandenberghe, L.P., Spier, M.R., Medeiros, A.B.P., Yamaguishi, C.T., De Dea Lindner, J., Pandey, A., Soccol, V.T., 2010. The Potential of Probiotics: A Review. Food Technology and Biotechnology 48, 413–434.

Thakur, A.K., Shakya, A., Husain, G.M.,Emerald, M., Kumar, V., 2014. Gut-Microbiota and Mental Health: Current and Future Perspectives. Journal of Pharmacology & Clinical Toxicology 2, 1-15.

Venugopalan, V., Shriner, K.A., Wong-Beringer, A., 2010. Regulatory Oversight and Safety of Probiotic Use. Emerging Infectious Diseases 16, 1661-1665.

Yakult Central Institute for Microbiological Research. 1998. Lactobacillus casei strain Shirota. Yakult Honsha Co. Ltd., Tokyo, Japan.

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14 nutraceuticals now nutraceuticals now 13

But what if your company hasn’t integrated quality management into every aspect of its operations? Perhaps you are the lone champion of quality in your organization. If so, there’s never been a better time to make your case for a corporate investment in quality. While it’s difficult to calculate the precise return on investment (ROI) of quality, the cost of high-profile consent decrees, FDA fines, legal battles and product recalls make a compelling financial case.

On the other hand, your company may already take quality very seriously and make every effort to adhere to the current GMPs. You may feel your company is doing everything right and you are ready for an FDA inspection today. Don’t be so sure. At NSF International’s dietary supplement training division, we’ve conducted hundreds of GMP audits against 21 CFR 111 for clients and turned up surprising — sometimes shocking — oversights in quality management practices. A few examples:• A rubber-gloved worker handling ingredients and taking a moment to wipe his runny nose, then

returning to his work wearing those same gloves.• Inappropriate use of equipment, like the time our auditors witnessed ingredients being mixed with a hand-held drill — the kind you’d find at your local home improvement store.• A dirty wooden pallet accidentally contaminating dietary supplement ingredients as they were poured into a mixer. • Inadequate documentation of an otherwise thorough cleaning of a mixer. Remember the FDA mantra: If it isn’t written down, it didn’t happen.

All of these examples illustrate the importance of developing a culture of quality in your organization. It’s not as simple as hanging a quality pledge on the wall and updating your employee handbook. Quality concerns must be integrated into every step of the production process and embraced by every employee in your organization — from production line workers to senior executives. Fortunately, resources are available to help dietary supplement manufacturers develop comprehensive quality management programs and technically competent leaders that will help ensure consumer safety and avoid significant legal and financial exposure.

TRAINING IS THE FIRST STEPThe courses are offered throughout the year in locations that are convenient for dietary supplement industry professionals. Courses are offered at major industry trade shows and in dietary supplement industry hotspots such as Arizona, California, New York, Salt Lake City and Florida.NSF Dietary Supplements Training and Education course topics are:• An overview of 21 CFR 111 GMP (Good Manufacturing Practices)• Standard operating procedures and recordkeeping for compliance to 21 CFR 111• How to prepare for an FDA inspection• Corrective action management• Testing method selection, specification setting and equipment qualification• Stability program development• Vendor qualification and audit training• Cleaning and control of cross-contamination• Risk assessment and risk management• Process definition and control; facility/utilities design and monitoring • Staff recruitment and internal training development• International regulatory requirements for dietary supplements

NSF International is the official trainer of the 2014 Supply Side West trade show. NSF is offering seven courses prior to the event; visit http://west.supplysideshow.com/gmp-training.aspx to register. • GMP 21 CFR 111 Overview • Botanical Testing • FDA Inspection Readiness • Batch Production Records – Do’s and Don’ts • SOP and Record Keeping for Compliance to 21 CFR 111 • The Top 10 Ways to Get a Warning Letter • NDI and GRAS Notification

It may be difficult to quantify the precise ROI, but it’s hard to argue against the value of quality training for dietary supplement industry professionals. For more information about the NSF Dietary Supplements Training Program and a calendar of upcoming training dates and locations, please visit the training website, call +1 734 827-6856 or e-mail [email protected]

The dietary supplements industry is facing increased scrutiny from the U.S. Food and Drug Administration (FDA) and the mainstream media — remember Dateline NBC’s March 2012 exposé of an alleged “dry lab” serving the dietary supplement industry? Since late 2011, the FDA has seized products and shut down several manufacturers for violations of 21 CFR 111 Good Manufacturing Practices (GMPs). Federal courts are handing down hefty fines and contempt sentences to dietary supplement manufacturers and executives found to be willfully violating federal regulations. While many say this negative attention damages the industry’s reputation, others argue it’s actually good for the industry. By shining a light on the very few manufacturers who are willfully ignoring the law, reputable companies with robust quality management systems have a golden opportunity to differentiate themselves in the marketplace. If your company has embraced a culture of quality and is adhering to the current GMPs, now is the perfect time to talk publicly about it. You’ll find plenty of consumers, retailers, media and legislators ready to listen.

Training for a culture of quality


A key role in energy productionAs one of its basic components, Ubiquinol supports the mitochondrial respiratory chain inside the body’s cells. This vital process produces more than 95 percent of our energy and supplies it to the heart, brain, muscles and everywhere else that energy is needed. Ubiquinol is therefore essential for high level performance – mentally as well as physically. Generally, the human body is able to produce its own Ubiquinol, and the micronutrient is also naturally present in many foods, including meat, fish and nuts. But the body’s natural Ubiquinol levels decline with age and it is virtually impossible to compensate for this via diet alone1. Used as a supplement, the electron-rich Ubiquinol has a more rapid and better effect than its precursor coenzyme Q10 since it does not have to be converted into an active form by the body. Its high bioavailability enables Ubiquinol to be taken up by the body more quickly and efficiently than traditional coenzyme Q102.

Ubiquinol is the only lipid soluble antioxidant that can be produced inside the body. It protects cell membranes from free radical damage and it contributes to their elasticity and flexibility. Within the inner mitochondrial membrane, this protection is especially important because reactive oxygen compounds called free radicals can occur here in high numbers during energy production. Furthermore, as an antioxidant, Ubiquinol helps to suppress the accumulation of mitochondrial DNA damage caused by free radicals, which results in accelerated aging3.

Supplementation in clinical therapyThe many scientific benefits of supplementation with Ubiquinol have already been well documented. Published clinical and experimental research shows that Ubiquinol affects cardiovascular health, neuronal metabolism, renal health and genes related to lipid/lipoprotein metabolism and inflammation.

Many studies have been conducted in the field of heart and cardiovascular disease. These have found evidence of coenzyme Q10 deficiency in individuals suffering from hypertension and heart failure as well as those taking statin medication. Ubiquinol supplementation as co-adjuvant therapy is effective in lowering diastolic blood pressure and improves heart functions such as pump volume and ejection fraction4. Ubiquinol also mediates a distinct reduction in LDL cholesterol levels and helps to prevent unwanted LDL oxidation.

Counteracting aging processes

Figure 1: The body’s natural Ubiquinol levels decline with age.

Coenzyme Q10 possesses the ability to slow down the aging process – which is related to an increased occurrence of free radicals – and positively influence many age-related diseases and health issues.

The active form of coenzyme Q10 counteracts aging processes and shows many benefits for use in nutritional supplements

According to the World Health Organization, between the years 2000 and 2050, on a global scale, the number of people aged 60 and over will more than triple. It is a social challenge to maximize health and quality of life with advancing age, and consumer demand for products that promote a wide range of anti-aging benefits is increasing. In this respect, the micronutrient Ubiquinol is becoming more and more important, with scientists currently investigating several new potential applications. The fully reduced form of the better known coenzyme Q10 holds a wealth of possibilities for improving and maintaining health in later years.

More quality of life

. . . healthy aging with Ubiquinol

In terms of brain health, for instance, coenzyme Q10 increases the production of adenosine triphosphate (ATP) and may increase levels of neurotransmitters such as acetylcholine in the brain. Coenzyme Q10 has also been shown to increase cognitive functions such as memory and learning ability, and may even slow down the progression of neurodegenerative diseases such as Parkinson’s5 and Alzheimer’s6 in their early stages. Another of Ubiquinol’s benefits is the maintenance of good eye health throughout life7. The retina is very sensitive to oxidation and therefore contains high concentrations of antioxidants such as vitamins C and E, beta-carotene, lutein, and coenzyme Q10. Here, Ubiquinol prolongs the activity of vitamins C and E by helping to regenerate them. It may also directly protect the retina from oxidation and glycation and may reduce the formation of age spots in the eyes, as well as on the skin.

Figure 2: Ubiquinol has a more rapid and better effect than its precursor coenzyme Q10.

Coenzyme Q10 is already widely used as a powerful ingredient in anti-aging cosmetics. Within the skin, coenzyme Q10 is primarily found in the surface layer of the epidermis, where it ensures the reutilization of vitamins C and E, as is required for skin regeneration and protection from ultraviolet light. Not only can coenzyme Q10 replenish the skin’s energy supply, but its antioxidant function also has an important role to play here because it protects cell membranes from free radical damage. Since coenzyme Q10 is a fat-soluble substance, it can penetrate into the deeper layers of the skin extremely well and is thus able to prevent many of the detrimental effects of daily aggressors and light-induced aging8.

Further research into the possible uses of coenzyme Q10 and Ubiquinol is ongoing. Researchers from Japan’s Shinshu University9 have investigated the effects of Ubiquinol supplementation and mitochondrial activation on metabolic processes related to aging. They used a special strain of mice which were characterized by high oxidative stress status and accelerated aging – and which therefore provided a good model for examining the potential effects of antioxidants on the aging process. A detailed biochemical evaluation was initiated in the mice, including measuring changes in different metabolic mediators, such as sirtuins – important regulators of physiology related to calorie restriction, exercise and aging. Ubiquinol is known to activate sirtuin pathways, thus preventing mitochondrial decay associated with aging and decelerating age-related diseases by increasing oxidative stress resistance. In this study, enhanced mitochondrial activity and a decline in damage caused by age-related oxidative stress were observed.

These findings may have implications for a wide range of conditions that are related to aging, such as diabetes, arthritis and neurodegeneration. This research is preliminary, but when further studies are carried out, Ubiquinol could become a foundational nutrient for brain, joint and glucose-metabolism formulations in the future.

Safe and naturalKaneka Q10™ and Kaneka QH™ Ubiquinol, both produced via yeast fermentation, are completely natural. As has been clinically documented10, Ubiquinol is well tolerated and proven to cause no adverse effects. Technically speaking, it can be used in a wide range of easily digestible products, including gel capsules, pellets and sticks. With its huge variety of health benefits, Kaneka QH™ Ubiquinol allows manufacturers of nutritional supplements and functional foods to target a broad spectrum of consumers – from sportspeople to stressed-out executives, the elderly and even those who are suffering from cardiovascular diseases.

References1 Kalén, A., et al.: Age-related changes in the lipid compositions of rat and human tissues. Lipids, 24(7):579-84 (1989).2 Hosoe, K., et al.: Study on safety and bioavailability of ubiquinol (Kaneka QH) after single and 4-week multiple oral administration to healthy volunteers. Regul Toxicol Pharmacol, 47(1):19-28 (2007). 3 Ernster, L. et al.: Biochemical, physiological and medical aspects of ubiquinone function. Biochimica et Biophysica Acta, 1271:195–204 (1995).4 Langsjoen, P. et al.: Supplemental ubiquinol in patients with advanced congestive heart failure. BioFactors, 32 (1–4): 119–28 (2008).5 Shults, C. et al.: Effects of Coenzyme Q10 in Early Parkinson Disease: Evidence of Slowing of the Functional Decline. Archives of Neurology 59 (10): 1541–50 (2002).6 Gvozdjáková, A. et al.: Coenzyme Q10 supplementation in an experimental model of Alzheimer’s Disease. 5th Conference of the International Coenzyme Q10 Association, Kobe, Japan. November 9-12th, 2007.7 Kernt, M. et al.: Coenzyme Q10 prevents human lens epithelial cells from light-induced apoptotic cell death by reducing oxidative stress and stabilizing BAX / Bcl-2 ratio. Acta Ophthalmol, 88(3):e78-86 (2010).8 Hoppe, U. et al.: Coenzyme Q10, a cutaneous antioxidant and energizer. Biofactors, 9(2-4):371-8 (1999).9 Tian, G, et al., Ubiquinol-10 supplementation activates mitochondria functions to decelerate senescence in senescence accelerated mice. Antioxidants & Redox Signaling (2013).10 Hidaka, T. et al.: Safety assessment of coenzyme Q10 (CoQ10). Biofactors. 32(1-4):199-208 (2008).

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3Scientists are currently investigating several new applications.

Consumers have been driving the trends in food markets for decades, from low-fat and fat-free to natural, organic and gluten-free. So it should be no surprise that the lines between the food world and nutraceuticals world are becoming more and more blurred as those same consumers are starting to demand similar changes be made by tablet, capsule and beverage companies’ formulators, producers and contract manufacturers.But Who Wants What?In a study recently conducted by British-owned Ulrick & Short, (referenced in Food Navigator Article) found that “75 percent of respondents stated that they wanted simpler labeling, while 45 percent are seeking to avoid artificial additives.” Of those surveyed, 70 percent went on to say that, “they are much more aware of their eating habits than they used to be, indicating that they are more likely to pay attention to what is in their food and on their labels.” Which begs the question, what do supplement consumers really want in regards to their ingredients? …clean labels.

If the stats from Ulrick & Short didn’t do it for you, Ingredion Europe has been conducting clean-label research across the globe for years, way before clean labels and gluten-free were the next big things. They have most recently teamed up with the market research experts at MMR Research Worldwide to regularly monitor how the demand for additive-free products is growing and evolving in global markets. (Reference information)

The countries polled in this round of studies included France, Germany, Italy, Spain, the UK, the United States, China, Japan, Australia, Mexico and the Netherlands. As the results were being analyzed , researched found an interesting number of trends to be true across all of the counties which paint a very interesting picture. These include: • Over 70% of consumers always or usually read the claims or descriptions on the front of the pack• 60% of consumers always or usually read the ingredient list on the back or side of the pack• Nearly 80% of consumers think a short, simple ingredients listing is important. The same number wanted to be able to recognize the ingredient listed• On-pack claims most likely to encourage brand switching are ‘low fat’, ‘natural’ and ‘no artificial ingredients’What are Clean Labels?We’ve established that consumers really want to understand what is on their labels and how it impacts their health and the health of their families and loved ones, but what exactly is a clean label? As definitions of health and wellness claims continue to grow and evolve as they increase in popularity, the idea of clean label supplement ingredients is no exception to the difficult to define trend.

Where do formulators start? With the consumer. And where is there access to millions of consumers? Social media website and all across the internet. By simply reading blogs, consumer reviews and articles written by interested consumers, formulators and contract manufacturers can gather a wealth of knowledge that can lead to what the consumer perceives as a clean label, in just seconds without created a single survey or hosting expensive focus group. The results? Supplement manufacturers have found that the hard to pronounce, ‘chemistry-lab” sounding ingredients are leaving them open to criticism, public defamation and the demanding out-cry for them to reformulate products so they are perceived to be clean label.

So, what exactly is a clean supplement label? The best definition that I have found to date is Datamonitor’s innovative insights director, Tom Vierhile in an article from Food-Navigator on June 18, 2014. (http://www.foodnavigator.com/Market-

Trends/What-do-natural-and-clean-label-mean-anyway). “As a working definition,” he says, “the primary implication of ‘clean label’ is transparency – in terms of the wholesomeness of the ingredients, lack of artificial ingredients, and often also the lack of common allergens.” Finding Replacement IngredientsNow that we’ve established and loosely defined what consumers are seeking when purchasing dietary supplements, what are the implications for formulators and contract manufacturers? They must find replacement ingredients that provide consumers the easy to read, clean labels they are demanding while still offering the team on the production line the optimal functionality they need.

One of the biggest trends in the supplement world is shifts in the excipients that are being used during tabletting and encapsulation. When consumers read the labels of their multivitamin to determine things like the percentages and Vitamin C and Iron, the last thing that they want to see when they get to the bottom of the label is the statement: made with Silicon Dioxide, Magnesium Stearate, Talc, Maltodextrin, along others. Educated consumers are beginning to ask the questions; What is this ingredient for? Is this ingredient safe for my family to consumer? Do I have an alternative and what is it?

In short, the answer to the option of an alternative is, yes! There are currently ingredients that are derived wholly from non-GMO, US grown and processed rice that gives consumers and producers the alternatives they are seeking.

Rice concentrate, which is derived from the hull of the rice plant is being commercially used as a replacement to the ever-prevalent Silicon Dioxide in supplements that is used to keep actives and other excipinets flowing freely through production equipment. Rice bran extract, is produced from the bran of the rice plant and is being used commercially as a replacement for ingredients such as magnesium stearate and dextrins. The natural oil from the rice bran helps lubricate equipment allowing tablets to slip freely from their dies and punches during production as well as assists in compaction necessary for a firm tablet. What are the Challenges of These Changes for Producers?One of the most important and impact changes that can come from consumer demand is changes to allowed and restricted ingredients in both natural and organic supplement production. This time around, the implication is falling on those in the organic supplement market space.

In May of 2013, the U.S. Department of Agriculture (USDA) gave manufacturers of organic foods and beverages using silicon dioxide (SiO2) a deadline – switch to using ingredients made of organic rice hulls, if commercially available, by November 3, 2014, or don’t make an organic product claim. Use of SiO2 as a defoamer continues to be allowed.

The reason? SiO2 is a synthetic ingredient formerly permitted since 1990 for use in organic products as there was no organic alterative. However, in 2007, an equally effective, commercially available alternative ingredient, made of hulls from U.S.-grown organic rice because available. As a result of USDA’s May 28, 2013, decision, as well as increased general consumer interest in clean labels with ingredient names they can understand, organic food, beverage, and supplement manufacturers have been increasingly reformulating their products using rice concentrate.

This change by the NOP and an overall more health-conscious and label reading consumer has triggered a demand in the supplements marketplace for cleaner, less chemical-sounding ingredients. Formulators have also been able to meet these demands with their ingredient rice concentrate, which is being used as a Magnesium Stearate replacement in the production of both tablets and capsules.

“Processing dietary supplements is tough enough and no one wants powders to clump or be tough to blend, compact or bind up equipment,” explains Steve Peirce, RIBUS Co-founder and President. “Rather, they want ingredients that keep powders flowable through and release easily during tablet and capsule production equipment.”

Clean Labels

Sales of omega-3s in the US have declined steadily over the past two years, resulting in 12 million consumers leaving the category and approximately $150-200 million in lost sales, according to the Global Organization for EPA & DHA Omega-3s (GOED), Salt Lake City, UT. GOED attributes much of the decline in omega-3s, especially fish oil, to falling consumer confidence and a negative prostate cancer study, which was published in mid-2013. Current market trends reflect a maturing and changing marketplace that for more than a decade has experienced strong double-digit growth. (See Figure 1)

Figure 1: Negative Media Contributed to Recent Omega-3 Decline

Source: GOED

According to SPINS/IRI (for 52 weeks ending 7.14.14), fish oil sales were down more than 11% and krill sales were down around 2% in the mass market. Collectively, GOED says, the entire omega-3 category is down more than 11% in the mainstream market.

So where does the market go from here? If recent surveys are any indication, the future might be brighter than most people think. A survey performed by Aker BioMarine/Holistic Primary Care showed that despite the relative negativity in the omega-3 space, nearly 30% of doctors are recommending omega-3s MORE than they were a year ago.

Can Health Practitioners Help Save the Omega-3 Category?Health Practitioners in the US represent the most trusted source of health information for consumers. The great news for omega-3s is that doctors’ willingness to recommend them is high (88%), with 35% reporting that they “Always” recommend them, and 53% saying they “Frequently” recommend them. Of note, only 2% report never recommending omega-3s. In addition, omega-3s are the most recommended nutrients among health professionals. (See Figure 2)

While “Heart Health” remains the top reason for which respondents recommend omega-3s (82%), clinicians clearly recognize other health benefits, including: “Inflammation Reduction” (81%); “Cognitive/Mood Effects” (80%); and “Joint Health” (65%).

When considering recommending omega-3s to patients, most doctors (74%) base their decisions on “Fatty Acid Composition.” More specifically,

Forging Ahead in the Omega-3 MarketOmega-3s are entering a new era, one where market research and clinical substantiation will dictate success, and where sustainability issues can no longer be pushed out to sea. By Becky Wright, Marketing Director, Aker BioMarine Antarctic US

We believe the media environment is a significant driver of the declining market

Consumer Exposure to Omega-3Stories in Major Media US Outlets

% o

f Con

sum

ers

Expo

sed

Consumers Exposed to PositiveStories in Major Media US Outlets

100%90%80%70%60%50%40%30%20%10%0%

18,000,000

16,000,000

14,000,000

12,000,000

10,000,000

8,000,000

6,000,000

4,000,000

2,000,000

2008

-Q1

2008

-Q3

2009

-Q1

2009

-Q3

2010

-Q1

2010

-Q3

2011

-Q1

2011

-Q3

2012

-Q1

2012

-Q3

2013

-Q1

2013

-Q3

2008

-Q1

2008

-Q3

2009

-Q1

2009

-Q3

2010

-Q1

2010

-Q3

2011

-Q1

2011

-Q3

2012

-Q1

2012

-Q3

2013

-Q1

2013

-Q3

Negative Positive

Source: GOED analysis of Factiva data

100%

80%

60%

40%

20%

0%HerbalMedicines

Always Frequently Occasionally Never

Vitamins Omegs-3s Probiotics Homeopathics

9% 7%

47%53% 53%

35% 31%19%

29%

54%47%

12% 14%2% 2% 5%

13%

1%

37% 34%

HerbalMedicines

9%32

47%159

37%126

7%23 339

34%115

53%178

13%43

1%4 339

35%119

53%179

12%39

2%6 339

31%104

54%183

14%46

2%8 339

5%16

19%64

47%161

29%100 339

Vitamins

Omega-3s

Probiotics

Homeopathics

Frequently Occasionally Never TotalRespondents

Figure 2: How Often Doctors Recommend Supplements & Other Natural Health Products

Source: Aker BioMarine/Holistic Primary Care Survey, June 201420

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issues such as EPA/DHA ratio and the form of omega-3s (phospholipid vs triglyceride) matter most to this group. Criteria like “Organic” and “Non-GMO” are also important for 56% and 55% of doctors, respectively, while choosing a “Sustainable” omega-3 source is important to nearly half (46%).

Perhaps even more significant, this survey also showed that practitioners are not as reactive as consumers to “negative” studies. In fact, a majority – 68% – said their omega-3 recommendations have not changed at all in the last 6-12 months, during which there were several negative omega-3 studies; 29% said they are recommending omega-3s MORE often, and only 3% reported recommending them less frequently.

A Coalition to Reinvigorate Omega-3 GrowthAnother important step forward for omega-3s is rebuilding consumer confidence, which is a primary goal of the newly formed Omega-3 Coalition. The coalition, which started working together earlier this year, represents several players who have important roles to play in the omega-3 value chain, GOED being one of them.

GOED believes a major, non-branded, consumer-oriented marketing strategy is needed to affect a measurable stimulus on consumer demand. In this vein, it feels the best opportunity is to reignite trial to bring new users into the omega-3 category. Macro marketing studies have demonstrated that new users are the lifeblood of sustainable growth in CPGs (consumer packaged goods).

The Omega-3 Coalition includes companies that have supply chains in the marine omega-3 business, i.e. fish oil, krill oil, algae, as well as finished products that contain these ingredients. These companies – particularly steering committee members (so far: Aker BioMarine, Epax/FMC, DSM, GOED, TASA, and Omega Protein) — will help guide several agencies involved in advertising, PR, retail activation and web design toward the execution of a comprehensive omega-3 marketing campaign. A test market for this activity commenced in September in Charlotte, NC, with a national rollout of the campaign planned for January 2015. (See Figure 3)

Growing Clinical SubstantiationBesides surveys and large scale marketing campaigns, solid clinical substantiation will continue to grow in importance for the omega-3 category, as companies look to use that evidence to differentiate their products in the supplement aisle.

For Superba™ Krill in particular, its most recent chance to shine clinically came in the February 2014 edition of Nutrition Research. This 300-subject clinical trial showed krill’s ability to significantly lower blood triglycerides and raise the omega-3 index.

The purpose of the study was to evaluate Superba™ Krill’s influence on blood lipids in subjects with “borderline high” or “high” triglyceride (TG) levels. A total of 300 volunteers were divided into five groups and supplemented with krill oil at either 0.5, 1, 2 or 4 grams per day or placebo (olive oil). The subjects included in the study had blood TG values between 150 and 499 mg/dL. Blood lipids were measured at baseline, 6 weeks and 12 weeks of treatment.

Relative to subjects in the placebo group, those administered krill oil had a statistically significant 10% reduction in serum TG levels. Moreover, LDL cholesterol levels were not increased in the krill oil groups relative to the placebo group, an important finding considering an increase in LDL cholesterol has been observed in some fish oil trials.

Another notable aspect of the study was Superba™ Krill’s ability to raise subjects’ omega-3 index, particularly among those taking the highest amounts.

“It is interesting to point out that with the highest dose of krill oil, the omega-3 index increased by 70%. Even with the lowest dose of 500 mg krill oil, there was a significant increase. Thus, this might have an impact on the risk of sudden cardiac death, which has been demonstrated in several studies during the last decade,” said Dr. Clemens Von Schacky, co-inventor of the HS Omega-3 Index Blood test.

The omega-3 index is a diagnostic tool that is becoming more familiar to health professionals as well as consumers. For the future, many experts are predicting a notable increase in its use as a way to measure the health benefits of omega-3s.

Sustainability: A Prerequisite for Doing Business in Omega-3sSupply chains in the omega-3 market are complicated and require close attention, and krill is no exception. Because the marine oils sector sometimes faces harsh criticism regarding the supply and quality of raw materials, it is crucial to address these concerns openly and honestly. In today’s market, an omega-3 company simply cannot do business without putting environmental responsibilities at the top of the priority list.

The challenge is figuring out how to balance these responsibilities with the needs of consumers globally. According to GOED, the market will need far more EPA & DHA than is currently being supplied in order to meet future health needs. (See Figure 4) In light of this, businesses have no choice but to operate sustainably, and the market has no choice but to welcome additional legitimate

We have recruited expertise from marketing agencies tobuild this campaign and a September test market is planned, followed by a national campaign.

Public relationsDevelop a robust PR effortbased on the idea to targetthe single test market, andthen be scaled nationally

Website/DigitalAdapt web assetst to fit the new campaign objectives and create assets

Retail ActivationCreate below-the-line and retail activation based on the idea, as well as man-age agency collaboration points

AdvertisingCreate an organizingcommunication idea, as wellas above-the-line advertisingcomponents

Figure 3: Agencies Recruited to Execute a New US Omega-3 Consumer Campaign Source: GOED

sources of marine omega-3s in an effort to meet consumers’ future health needs.

On the consumer level, sustainability and traceability are two elements driving 1/3 of purchasing decisions in the marketplace today, and their influence in the omega-3 market is growing, according to a Today’s Dietitian Survey (January 2014).

Aker BioMarine’s krill fishery is certified by the Marine Stewardship Council (MSC) as being sustainable and 100% traceable. In fact, the company just entered a comment period for the renewal of this certification. If successful, this will re-certify the sustainability and 100% traceability of Superba™ and Qrill™, the company’s flagship krill ingredients for another five years.

Comprehensive interviews were carried out as part of this recertification process, complemented by a full and thorough review of relevant literature and data sources. Key stakeholders in the fishery – including skippers, scientists, fishery protection officers, NGOs (non-government organizations),

fishery managers and technical support staff – were crucial to the development of this report. Some of the specific stakeholders included WWF-Norway, Greenpeace and the British Antarctic Survey. This type of comprehensive approach is precisely what’s needed in order to harvest krill sustainably and at the same time closely monitor the health of the biomass.

To add another layer of transparency, Aker BioMarine is pursuing non-GMO verification through the Non-GMO Project. More than 2,200 brands manufacturing more than 20,000 products now carry the Non-GMO Project verification. Sales of those products total more than $7 billion annually, according to the Non-GMO Project. And the organization continues to receive 70-80 new verification inquiries per week. Most recently, Whole Foods Market reported sales increases of 15-30% for “Non-GMO Project Verified” products, making it the fastest growing label in the food industry.

Today in the U.S. more people are seeking “non-GMO” on food labels than “organic.” In fact, nearly 20% of shoppers, according to the Hartman Group, are actively seeking foods labeled non-GMO. Additionally, about a third of consumers are actively avoiding foods with GMOs.

In the future, success will not come easy for omega-3s. Recent trends have proven that omega-3s will have to come to the table with more than just their name in order remain an important part of the nutritional landscape.

The problem is the oceans do not provide enough EPA and DHA today and there are already fears about overfishing in many species.

Our EPA/DHA Needs(thousands of tons)

The Ocean’s Capacity(thousands of tons)

2550

JapanModel

MotrtalityModel

WHOModel

Seafood Consumption: 125Seafood Waste: 200Reduction fisheries: 205

1020

650530

AdvertisingCreate an organizingcommunication idea, as wellas above-the-line advertisingcomponents

Source: GOED analysis of FAO and USDA data

Figure 4: Sustainability is Paramount in the Marine Omega-3 BusinessSource: GOED


Obesity has become a worldwide problem and the health burden of obesity-related complications is growing. This is because overweight and obesity lead to adverse metabolic effects on blood pressure, cholesterol, triglycerides and insulin resistance. If there was a simple explanation to this epidemic problem, there would be a simple solution. We all know though that obesity results from energy imbalance—too many calories in, too few calories burned.

The Value of Chitosan . . . as a Dietary Fiber

PRIMEX offers natural, effective and convenient solutions for weight management

The healthy keys to weight management include: monitoring calorie and fat intake, being active and following a healthy lifestyle. But why does this not work for everybody? Modernization, globalization and current life-style conditions contribute to the obesity problem. People eat differently nowadays and spend less energy. They become tempted by short-term weight loss solutions instead of following a long-term weight management program and choose a suitable lifestyle. A slow and steady weight loss plan is emphasized, being well supported by delicious, nutritive and well balanced food choices. Improved eating habits, appropriate portion sizes and physical activity are important for a successful weight management plan which must be tailored to individuals’ needs. Nevertheless, the most effective way to achieve weight loss is to reduce calories in our meal. This can be accomplished by the selection of appropriate food products, especially those that minimize hunger, fill the stomach and contribute to low caloric intake, such as

dietary fiber.A dietary fiber is a carbohydrate not digested in the

small intestine, but that can be fermented by commensal bacteria once in the colon, resulting in the production of short chain fatty acids (SCFAs) and gases. In the human gut, SCFAs are an important source of energy for the gut and some are transported to other sites around the body for use. The gut microbiota interacts with the host through its metabolites. Some metabolites can damage the gut mucosa, such as indoles, ammonia and amines, while others are beneficial, such as SCFAs [1]. Lin et al. [2] examined the effects of SCFAs on body weight, glucose metabolism, and gut hormones in mice and demonstrated that butyrate, propionate, and acetate all protected against diet-induced obesity and insulin resistance. Interestingly, butyrate and propionate, but not acetate, induced gut hormones and reduced food intake. Dietary fibers can therefore be used as prebiotics, i.e. nondigestible food ingredients selectively stimulating the growth and


activity of bacterial species in the colon. Accumulating evidences indicate that prebiotics have a diverse range of health benefits, particularly by influencing microbial gut ecology, mineral absorption, laxation, potential anticancer properties, and lipid metabolism, together with anti-inflammatory and other immune effects, including atopic disease. Fermentation processes and SCFA production in the large intestine are believed to contribute to several of these phenomena [3].

The physico-chemical properties of dietary fibers play other important roles in human physiology. Dietary fibers are differentiated based on their water solubility which is related to their structure. The soluble and insoluble nature of dietary fibers contributes to their different technological functionality and physiological effects. Technological properties in foods include water-holding capacity, swelling, oil-holding capacity, viscosity, texturizing, stabilizing, gel-forming and antioxidant; all greatly relevant to the food industry to improve texture, sensory characteristics and shelf-life. In the human body, soluble fibers increase viscosity and reduce the glycemic response and plasma cholesterol, while insoluble fibers are porous, contributing to fecal bulk and decreased intestinal transit time [4]. Recently, Kristensen and Jensen [5] reviewed several studies where the majority of them indicated that viscous dietary fiber enriched beverages increased the sensation of satiety or fullness. Indeed, dietary fibers have three primary mechanisms in the human digestive tract: bulking, viscosity and fermentation.

Chitosan is a natural dietary fiber and the most abundant natural amino polysaccharide. It is obtained by deacetylation of chitin processed mainly from animal (crustacean shell) or fungal (mushrooms and related microorganisms) source. Chitosan, a copolymer of glucosamine and N-acetyl-glucosamine, is soluble in acidic environment following its protonation, resulting in its unique cationic and bioactive nature. This characteristic offers a great potential as a dietary fiber since chitosan will first dissolve in stomach acid and become soluble and viscous, behaving like a soluble fiber. Once transiting to the intestine the higher pH will cause it to gel and become less soluble, contributing to faster transit time and reduced putrefactive activity. This is advantageous because rapid intestinal transit is linked to higher energy recoveries by the host due to increased bacterial metabolite production in the colon [3]. Chitosan has been demonstrated to possess several biological properties, among which antioxidative, emulsifying, flocculating, fat-binding and antimicrobial, are important ones for the food industry [6]. Indeed, chitosan can chelate fat and reduce cholesterol [7-8] and do not influence calcium, magnesium and iron status (8-week elderly study) [9]. According to EFSA, a daily consumption of 3-g chitosan will contribute to the maintenance of normal blood LDL cholesterol concentrations [10].

Primex ehf, an Icelandic marine biotech company, is a global leader in the manufacture and supply of pure chitin and chitosan products. The combination of high quality marine raw materials and a unique processing technology allows Primex to produce the purest and most effective chitosan on the market today. Primex products are certified as natural, and include ChitoClear® chitosan of different grades and viscosities for various applications, and LipoSan Ultra® chitosan, which is a safe and effective weight loss and cholesterol lowering supplement. LipoSan Ultra® is a unique, patented product (US Patent

No. 6,130,321) that contains succinic acid, a GRAS food additive. The LipoSan Ultra® patented process results in a more granular product with high tap density and much better flow properties than regular chitosan, allowing easier and faster capsule filling as well as higher fill weights, resulting in fewer capsules at meal time. LipoSan Ultra® rapidly dissolves in the stomach, complexes and traps fats and oils consumed, and reduces the digestion of dietary fat hence limiting the calorie intake. This superior efficacy of LipoSan Ultra® implies that it can be taken just before a meal as a convenient weight management product.

Clinical studies have already demonstrated the advantages of Primex products to human health. LipoSan Ultra® (3 g daily for 8 weeks) has been shown to be efficacious in facilitating weight loss and reducing body fat and LDL-cholesterol in overweight and mildy obese individuals (BMI 31-32) despite simple routines and minimal changes of lifestyle [11]. Similarly, ChitoClear® chitosan (4.5 g daily for 6 months) supplemented to a low calorie diet (1000 kcal/day) contributed to significantly higher body weight loss and decrease of systolic and diastolic blood pressure in fifty obese women [12]. Another study revealed that daily consumption of ChitoClear® chitosan (4.5 and 6.75 g) for 8 weeks did not affect serum-fat soluble vitamins or other safety parameters in 56 mildy hypercholesterolemic Finnish subjects (BMI ≤ 26) eating a typical diet. Modest reduction in plasma cholesterol concentrations were observed [13]. In a guinea pig study, ChitoClear® chitosan was also shown to selectively reduce fat absorption and have higher affinity to bind fatty acids with higher polarity. ChitoClear® chitosan significantly increases the excretion of highly atherogenic saturated fatty acids (lauric and myristic) compared to other fibers. Intestinal bioconversion of cholesterol and bile acids is therefore inhibited by ChitoClear® chitosan. Furthermore, the ratio of n−6/n−3 fatty acids in feces is significantly increased by ChitoClear® chitosan [14], which could be tactically used to balance this fatty acid ratio in our diet, hence reducing the risk of many chronic diseases [15].

Furthermore chitosan, being a source of dietary fiber, is also a valuable prebiotic which can promote optimal colonic conditions. Back in 1995, Terada and coworkers [16] showed that a 2-week intake of chitosan (3 g daily for 7 days and then 6 g) led to reduced occurrence of lecithinase-negative clostridia and fecal concentrations of putrefactive products (ammonia, phenol, p-cresol and

indole) which resulted in less offensive fecal odors. After 14-day intake, SCFA levels had significant increased, especially propionic acid formation. Unfortunately, few studies have considered these beneficial effects of chitosan on human health but recent publications indicate its potential to modulate the colonic microbiota [17-18]. Mrazek et al. [19] observed changes in overall bacterial composition and bifidobacteria subpopulation in response to chitosan intake (3 g daily) after only 2-3 days. This was reflected by raised levels of fecal Bacteroides, slightly increased or unchanged levels of Bifidobacterium and a little increase in butyrate-producing bacteria. After termination of the 4-week chitosan treatment, it took only 2 days to reestablish the initial microbiota. Similarly to the work of Lee et al. [20], the findings point to a prebiotic effect of chitosan on Bifidobacterium, beneficial for human health. This stimulating effect is meaningful for the use of chitosan to encapsulate probiotic cultures.

The design of functional foods that would generate specific SCFA patterns at controlled sites in the large intestine is an interesting challenge aiming for positive health consequences, e.g. in the prevention and treatment of colonic diseases. ChitoClear® chitosan is obviously a good candidate, just as LipoSan Ultra®. In more, Primex has developed Encapsulated LipoSan Ultra® for applications in ready-to-eat functional foods and beverages, opening new market opportunities for the convenience and functional food market. The encapsulation is an ingenious means to protect LipoSan Ultra‘s bioactivity from the food matrix. The encapsulation remains even in acidic foods, like juices, but in stomach it breaks and chitosan becomes active in the digestive tract by contributing to viscosity, bulk, fat-binding and fermentative processes. Its use should enhance overall human health and alleviate current chronic disease problems.

More information on Primex chitin and chitosan products are available at www.primex.is. Information on Primex revolutionary LipoSan Ultra® natural weight control supplement can be found at www.liposan.com.

Hélène L. Lauzon, Ph.D.Director of Research and DevelopmentPrimex ehf Oskarsgata 7, 580-Siglufjordur, IcelandPhone: (+354) 460 [email protected]

References1. Brownlee IA (2011) The physiological roles of

dietary fibre. Food Hydrocolloids 25: 238-250.2. Lin HV, Frassetto A, Kowalik EJ Jr, Nawrocki AR,

Lu MM, Kosinski JR, Hubert JA, Szeto D, Yao X, Forrest G, Marsh DJ (2012) Butyrate and propionate protect against diet-induced obesity and regulate gut hormones via free fatty acid receptor 3-independent mechanisms. PLoS ONE 7(4): e35240.

3. Macfarlane GT, Macfarlane S (2011) Fermentation in the human large intestine - Its physiologic consequences and the potential contribution of prebiotics. J Clin Gastroenterol 45: S120–S127.

4. Roehrig KL (1988) The physiological effects of dietary fiber – A review. Food Hydrocolloids 2: 1-18.

5. Kristensen M, Jensen MG (2011) Dietary fibres in the regulation of apetite and food intake. Importance of viscosity. Appetite 56: 65-70.

6. Aranaz I, Mengibar M, Harris R, Panos I, Miralles B, Acosta N, Galed G, Heras A (2009) Functional characterization of chitin and chitosan. Curr Chem Biol 3: 203-230.

7. Kumar RMNV (2000) A review of chitin and chitosan applications. React Funct Polym 46: 1–27.

8. Xu G, Huang X, Qiu L, Wu J, Hu Y (2007) Mechanism study of chitosan on lipid metabolism in hyperlipidemic rats. Asia Pac J Clin Nutr 16: 313–317.

9. Liao F-H, Shieh M-J, Chang N-C, Chien Y-W (2007) Chitosan supplementation lowers serum lipids and maintains normal calcium, magnesium, and iron status in hyperlipidemic patients. Nutr Res 27: 146-151.

10. EFSA Journal 2011; 9(6):2214 [21 pp.]. doi:10.2903/j.efsa.2011.2214

11. Schiller RN, Barrager E, Schauss AG, Nichols EJ (2001) A randomized,double-blind, placebo-controlled study examining the effects of a rapidly soluble chitosan dietary supplement on weight loss and body composition in overweight and mildy obese individuals. J Amer Nut Ass 4(1): 42-49.

12. Zahorska-Markiewicz B, Krotkiewski M, Olszanecka-Glinianowicz M, Zurakowski A (2002) Ocena zastosowania chitosanu w kompleksowym leczeniu otylosci. [Effect of chitosan in complex management of obesity]. Polski merkuriusz lekarski : organ Polskiego Towarzystwa Lekarskiego 13: 129-132.

13. Tapola NS, Lyyra ML, Kolehmainen RM, Sarkkinen ES, Schauss AG (2008) Safety aspects and cholesterol-lowering efficacy of chitosan tablets. J Amer Coll Nutr 27: 22-30.

14. Santas J, Espadaler J, Mancebo R, Rafecas M (2012) Selective in vivo effect of chitosan on fatty acid, neutral sterol and bile acid excretion: A longitudinal study. Food Chem 134: 940-947.

15. Simopoulos AP (2002) The importance of the ratio of omega-6/omega-3 essential fatty acids. Biomed Pharmacotherapy 56: 365.

16. Terada A, Hara H, Sato D, Higashi T, Nakayama S, Tsuji K, Sakamoto K, Ishioka E, Maezaki Y, Tsugita T, Takekawa T, Mitsuoka T (1995) Effect of dietary chitosan on faecal microbiota and faecal metabolites of humans. Microbial Ecology in Health and Disease 8: 15-21.

17. Vernazza CL, Ginson GR, Rastall RA (2005) In vitro fermentation of chitosan derivatives by mixed cultures of human faecal bacteria. Carb Polymers 60: 539-545.

18. Simunek J, Tischenko G, Hodrova B, Baptonoca H (2006) Effect of chitosan on the growth of human colonic bacteria. Folia Microbiol 51: 306-308.

19. Mrazek J, Koppova I, Kopecny J, Simunek J, Fliegerova K (2010) PCR-DGGE-based study of fecal microbial stability during the long-term chitosan supplementation of humans. Folia Microbiologia 55: 352-358.

20. Lee H-W, Park Y-S, Jung J-S, Shin W-S (2002) Chitosan oligosacharides, dp 2-8, have a prebiotic effect on the Bifidobacterium bifidium and Lactobacillus sp. Anaerobe 8: 319-324.


By Vijaya Juturu, PhD, FACN, OmniActive Health Technologies and Lynda M. Doyle, MBA, MS Human Nutrition, OmniActive Health Technologies

Well over 600 carotenoids exist in nature, providing color to the world around us. Of the 40-50 that are found in our diet, only three carotenoids are present in the eye, specifically in the macula–lutein and the zeaxanthin isomers–3R,3’R-zeaxanthin (RR-zeaxanthin) and 3R,3’S-zeaxanthin (RS- [or meso-] zeaxanthin)–collectively referred to as the macular carotenoids (Figure 1). These three carotenoids enhance macular pigment, and their concentration in the macula is highly specific: lutein is preferentially deposited in the peripheral macula, RR-zeaxanthin in the mid-peripheral macula and RS-zeaxanthin at the very center of the macula (fovea) (Exp Eye Res 1997; 64:211-218). Macular pigment is the protective component in the eyes and is important in maintaining their integrity. Maintenance of macular pigment is important for optimal visual performance because of its blue light-filtering properties and consequential attenuation of chromatic aberration, veiling luminance and blue haze. In the macular pigment, lutein and zeaxanthin isomers absorb harmful, high-energy (UVA and blue LED) light, thereby preventing macular damage. Exposure to high energy sources of light from the sun (UVA) and electronic devices (blue LED light) can damage the eyes over a period of time. Blue light filtration of macular carotenoids preserves visual acuity and the ability to see in dim light.

Lutein and zeaxanthin isomers perform several protective functions. They are potent antioxidants against oxidative stress and lipid peroxidation in nerve and retinal tissue, especially in the eyes and brain. Lutein and zeaxanthin isomers are thought to be more effective than other antioxidants - including vitamin E–at inhibiting lipofuscin, the remains of damaged and dead cells which accumulate in the retina with age and is associated with cellular degeneration and vision loss. Lutein and the zeaxanthin isomers also span the entire membrane bilayer, which helps stabilize cell membranes. Their polar cyclic end groups extend into the aqueous environment both inside and outside of the cell, enabling the antioxidant to be recharged by vitamin C and other water-soluble antioxidants.

Lutein and zeaxanthin isomers have been shown to filter blue light and reduce the formation of lipofuscin and induced apoptosis of cultured RPE cells exposed to high-energy blue light (Sundelin et al., 2001). They are capable of quenching reactive oxygen species such as singlet oxygen, and

Macular Carotenoids. . .Natural antioxidants for a lifetime of healthy vision

Eye health continues to be a top health concern amongst consumers around the world. But it’s no longer only about age-related eye health. We are now seeing a new set of vision concerns emerge as a result of early and heavy use of computers and other electronic devices. Individuals of all ages are constantly at their monitors and handheld devices, resulting in eye fatigue and strain. This expansion of the age demographic due to increasing assaults to the eye is the most compelling new development shaping the growing eye health supplement category today. Certain carotenoids, such as lutein and zeaxanthin isomers, are gaining popularity because of their cumulative protective benefits for vision and brain health. Recent studies have been conducted in various age groups and suggest that the effects of these carotenoids are advantageous when taken early—starting in pregnancy/lactation for mother and child—and consistently through a lifetime.

Figure 1 Molecular Structures of Lutein and Zeaxanthin Isomers

HO

HO

HO

OH

OH

OH

Lutein

(3R,3’R)-Zeaxanthin

(3R,3’S;meso)-Zeaxanthin

are effective scavengers of free radicals (Stahl and Sies, 2002, 2003; Sies and Stahl, 2003; Loane et al., 2008). The generation of free radicals and other reactive oxygen species can damage deoxyribonucleic acid (DNA), proteins and lipids, and ultimately affect the integrity and stability of subcellular structures, cells, and tissues (Stahl and Sies, 2002). Exposure to UV light can result in lipid peroxidation and the generation of peroxyl radicals; thus, lutein and zeaxanthin isomers are thought to play an important role in the protection against oxidative stress, particularly in tissues such as the skin and eyes that are continuously exposed to oxygen and damaging UV light (Stahl and Sies, 2003).

The antioxidative properties of lutein and zeaxanthin isomers have garnered much interest beyond protection against photo-oxidative damage to include effects on DNA damage and repair. In vitro and in vivo studies have confirmed that lutein and zeaxanthin isomers have the capacity to: decrease double strand breaks and DNA cross-linking, inhibit mutagenecity of aflatoxin, suppress the initiation stages of hepatocarcinogenesis, and protect against hepatotoxins (i.e., ethanol, paracetamol, and carbon tetrachloride) (Santocono et al., 2006; Moreno et al., 2007; Wang et al., 2008; Serpeloni et al., 2010; Sindhu et al., 2010; He et al., 2011).

Lutein and zeaxanthin isomers not only neutralize most free radicals but also activate antioxidant enzymes. The three macular carotenoids differ in their antioxidant spectrum and complement each other, especially in the macula. Macular pigment optical density (MPOD) formed by lutein and zeaxanthin isomers is associated with clear vision and resistance to age-related eye diseases such as age-related macular degeneration (AMD) and cataracts, the leading causes of blindness in the western world. Compelling science has shown that long term supplementation in humans with macular carotenoids may assist in maintaining the integrity of healthy vision– visual performance and acuity, as well as aid glare and contrast sensitively, and support vision in dim light and chromatic blur.

Supplementation with lutein and zeaxanthin isomers has been shown to enhance MPOD and increase macular carotenoid levels in the blood and tissues (reviewed in Alves-Rodrigues and Shao, 2004; Whitehead et al., 2006). Over three decades of research in humans have demonstrated the protective role lutein and zeaxanthin isomers play in eye health and in the defense against AMD and cataract (Age-Related Eye Disease Study 2 Research Group, 2013; Ma et al., 2012). Lutein and zeaxanthin isomer doses reported in the clinical studies ranged from 6-40 mg per day over a period of up to five years. An association of macular pigment density (MPOD) and indices of visual performance, such as enhanced chromatic contrast, temporal vision, and photo stress recovery, as well as reduced visual discomfort from glare have been reported (Stringham and Hammond, 2005; Lien and Hammond, 2011).

In clinical studies, no adverse changes in haematology, clinical chemistry, or visual function have been reported following supplementation with lutein and zeaxanthin isomers at doses up to 40mg/day, for durations up to five years. Lutein and zeaxanthin isomers are considered safe for use in food, beverage and dietary supplements and meet the regulatory criteria per the FDA-acknowledged GRAS notification filed by OmniActive Health Technologies for Lutemax® 2020 Lutein with Enhanced Levels of Zeaxanthin Isomers. Lutemax® 2020 was also proven safe in clinical and preclinical studies published in Food Chemical Toxicology (Krishnan, et al., 2011).

Humans lack the ability to synthesize carotenoids de novo; thus, lutein and zeaxanthin isomers must be obtained through either dietary sources or dietary supplements (Stahl and Sies, 2003). Epidemiological data indicate that the average intake of lutein and zeaxanthin from dietary sources is in the range of 1 to 2 mg/day, which is far less than the levels shown to have beneficial effects on vision performance and function (IOM,

2000; JECFA, 2006; EFSA, 2010). Supplementation therefore becomes critical to help maintain eye health and visual performance throughout a person’s life.

Lutein and zeaxanthin isomers are strong carotenoids with protective effects like antioxidant, anti-mutagenic, singlet oxygen quenching and inhibitory effects on specific CYP450 isoenzymes, chemo-protective and anti-carcinogenic effects. The preservation of vision in most eye diseases will benefit from early detection and management with a healthy diet and exercise including macular carotenoids and to maintain the quality of life in aging. The three macular carotenoids work together for optimal eye health and visual function.

To enable their customers to meet the diverse needs of their formulators, markets and regulatory authorities, OmniActive Health Technologies offers the most innovative and complete range of macular carotenoids. Through their internationally recognized and award-winning product ranges Lutemax® Lutein ingredients and OmniXan™ RR-Zeaxanthin, OmniActive provides the following:• Lutemax® Free Lutein• Lutemax® Lutein Esters• OmniXan® RR-Zeaxanthin from Natural Paprika• Lutemax® 2020 Lutein and Enhanced Levels of Zeaxanthin Isomers• Lutemax® 2020-RR Lutein and Enhanced Levels of RR- Zeaxanthin

References1. Age-Related Eye Disease Study 2 Research Group. Lutein + zeaxanthin and omega-3 fatty acids for age-related macular degeneration: the Age-Related Eye Disease Study 2 (AREDS2) randomized clinical trial. JAMA. 2013 May 15;309(19):2005-15. 2. Mozaffarieh M1, Sacu S, Wedrich A. The role of the carotenoids, lutein and zeaxanthin, in protecting against age-related macular degeneration: a review based on controversial evidence. Nutr J. 2003 Dec 11;2:20.3. Serpeloni JM, Grotto D, Mercadante AZ, de Lourdes Pires Bianchi M, Antunes LM. Lutein improves antioxidant defense in vivo and protects against DNA damage and chromosome instability induced by cisplatin. Arch Toxicol 2010, 84(10):811-822.4. Ma L, Dou HL, Wu YQ, Huang YM, Huang YB, Xu XR, Zou ZY, Lin XM.5. Lutein and zeaxanthin intake and the risk of age-related macular degeneration: a systematic review and meta-analysis. Br J Nutr. 2012 Feb;107(3):350-9. doi: 10.1017/S0007114511004260. Epub 2011 Sep 8.6. Zhao L, Sweet BV. Lutein and zeaxanthin for macular degeneration. Am J Health Syst Pharm. 2008 Jul 1;65(13):1232-8. doi: 10.2146/ahjp080052.7. Johnson EJ. Role of lutein and zeaxanthin in visual and cognitive function throughout the lifespan. Nutr Rev. 2014 Sep;72(9):605-12.8. Yao Y, Qiu QH, Wu XW, Cai ZY, Xu S, Liang XQ. Lutein supplementation improves visual performance in Chinese drivers: 1-year randomized, double-blind, placebo-controlled study. Nutrition. 2013 Jul-Aug;29(7-8):958-64. doi: 10.1016/j.nut.2012.10.017. Epub 2013 Jan 27.9. https://www.nei.nih.gov10. IOM. β-Carotene and other carotenoids. In: Dietary Reference Intakes for Vitamin C,11. Vitamin E, Selenium, and Carotenoids. Panel on Dietary Antioxidants and Related Compounds, Subcommittees on Upper Reference Levels of Nutrients and Interpretation and Uses of DRIs,Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine (IOM). Washington (DC): National Academy Press (NAP), 2000, pp. 325-382. Available at: http://www.nap.edu/openbook.php?record_id=9810&page=325.12. JECFA. Lutein from Tagetes erecta L. In: Safety Evaluation of Certain Food Additives.


13. Sixty-third Meeting of the Joint FAO/WHO Expert Committee on Food Additives, 2006,June 8 17,Geneva, Switz. (WHO Food Additives Series, no 54). Geneva, Switz.: World Health Organization (WHO), International Programme on Chemical Safety (IPCS), 2004, pp. 49-86, 637-638.Available at: http://whqlibdoc.who.int/publications/2006/9241660546_eng.pdf.14. EFSA . Scientific Opinion on the re-evaluation of lutein (E 161b) as a food additive. EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS). EFSA J 2010, 8(7):1678. 15. Alves-Rodrigues A, Shao A. The science behind lutein. Toxicol Lett 2004,150(1):57-83.16. Whitehead AJ, Mares JA, Danis RP . Macular pigment: a review of current knowledge. Arch Ophthalmol 2006,124(7):1038-1045.17. Connolly EE, Beatty S, Loughman J, Howard AN, Louw MS, Nolan JM. Supplementation with all three macular carotenoids: response, stability, and safety. Invest Ophthalmol Vis Sci 2011, 52(12):9207-9217.18. Sundelin SP, Nilsson SE. Lipofuscin-formation in retinal pigment epithelial cells isreduced by antioxidants. Free Radic Biol Med 2001,31(2):217-225.19. Stahl W, Sies H. Carotenoids and protection against solar UV radiation. Skin Pharmacol Appl Skin Physiol 2002,15(5):291-296.20. Stahl W, Sies H. Antioxidant activity of carotenoids. Mol Aspects Med 2003,24(6):345-351Sies H, Stahl W.Non-nutritive bioactive constituents of plants: lycopene, lutein and zeaxanthin. Int J Vitam Nutr Res 2003, 73(2):95-100.21. Loane E, Kelliher C, Beatty S, Nolan JM. The rationale and evidence base for aprotective role of macular pigment in age-related maculopathy. Br J Ophthalmol 2008,92(9):1163-1168.

22. Santocono M, Zurria M, Berrettini M, Fedeli D, Falcioni G. Influence of astaxanthin, zeaxanthin and lutein on DNA damage and repair in UVA-irradiated cells. J Photochem Photobiol B 2006,85(3):205-215.23. Moreno FS, Toledo LP, de Conti A, Heidor R, Jordao A, Jr., Vannucchi H et al. Lutein presents suppressing but not blocking chemopreventive activity during diethylnitrosamine induced hepatocarcinogenesis and this involves inhibition of DNA damage. Chem Biol Interact 2007,168(3):221-228.24. Ravikrishnan R, Rusia S, Ilamurugan G, Salunkhe U, Deshpande J, Shankaranarayanan J, Shankaranarayana ML, Soni MG. Safety assessment of lutein and zeaxanthin (Lutemax 2020): subchronic toxicity and mutagenicity studies. Food Chem Toxicol. 2011 Nov;49(11):2841-8. doi: 10.1016/j.fct.2011.08.011. Epub 2011 Aug 22.25. Wang Y, King JM, Xu Z, Losso J, Prudente A. Lutein from ozone-treated corn retains antimutagenic properties. J Agric Food Chem 2008,56(17):7942-7949.26. Sindhu ER, Firdous AP, Preethi KC, Kuttan R. Carotenoid lutein protects rats from paracetamol-, carbon tetrachloride- and ethanol-induced hepatic damage. J Pharm Pharmacol 2010, 62(8):1054-1060.27. He RR, Tsoi B, Lan F, Yao N, Yao XS, Kurihara H. Antioxidant properties of luteincontribute to the protection against lipopolysaccharide-induced uveitis in mice. Chin Med 2011, 6(1):38. doi:10.1186/1749-8546-6-38.28. Stringham JM, Hammond BR Jr. Dietary lutein and zeaxanthin: possible effects on visual function. Nutr Rev. 2005 Feb;63(2):59-64.29. Lien EL, Hammond BR. Nutritional influences on visual development and function. Prog Retin Eye Res. 2011 May;30(3):188-203. doi: 10.1016/j.preteyeres.2011.01.001. Epub 2011 Feb 4.

The world´s population is aging rapidly. According to the WHO, the proportion of people over 60 years is expected to increase from 605 million to 2 billion between 2000 and 2050 [1]. In parallel, life expectancy is rising.

Careless® . . . the innovation for well-aging

Aging is associated with several structural and metabolic changes leading to a decrease in physical strength and endurance as well as to a decline in efficiency of body organs and a shift of body composition towards an increase in body fat mass. Many of these changes occurring from aging result from a gradual loss that often begins already around the age of 30 years.

Today´s aging consumers are thought to be the physically and mentally fittest in history. Young and old take personal responsibility for their health and are interested in measures to reduce the signs of aging and the risk of metabolic diseases that tend to strike as we age. Besides establishing lifestyle changes, consumers are looking for natural, safe alternatives to support their goal of lengthening their “healthy life expectancy”, i.e. the number of years in “full health”. Today, there is a difference of at least seven years between the “healthy life expectancy” and total life expectancy at birth [2]. Thus, products helping the aging consumer to close this gap between healthy life expectancy and total life expectancy may have a huge potential.

Careless® is a well-tasting, innovative and IP protected ingredient that helps you care less about aging by mimicking some of the effects of calorie restriction and exercise, two well-known measures to stay healthy and in shape.

Mango – “the king of fruits” –traditional use and efficacyWhat is Careless? Careless is a high quality mango fruit preparation with excellent taste providing a good basis for healthy food and dietary supplement concepts. Mango (Mangifera indica L.) is one of the most important tropical fruits, grown in more than 87 countries throughout the world [3]. It is not only a delicious fruit consumed at every stage of ripeness but also known for its traditional health benefits. Various parts of the plant (e.g. roots, bark, leaves, kernel) are used in Ayuvedic medicine to treat a broad spectrum of diseases including diarrhea, diabetes, liver diseases and many more [4].

The fruits of mango are known to contain significant levels of bioactive compounds including polyphenols and vitamins. The composition and concentration of bioactives is influenced by several factors such as genetic differences in cultivars, growing conditions,

ripeness and post-harvest handing [4, 5]. Mango polyphenols are highest during fruit growth and decrease with ripening. Analytical investigations of unripe fruits displayed even higher contents of polyphenols in unripe fruits.

The mango fruits used for Careless are harvested at a special degree of ripeness in order to ensure a high concentration of bioactive compounds. The use of unripe fruits also has technological advantages. The firm pulp can be sliced easily and dried under moderate conditions to produce a high quality fruit powder without deterioration of valuable compounds and related beneficial effects or of the great color and taste.

Secondary plant compounds such as polyphenols have been increasingly researched for their health benefits in particular with regard to the prevention of age related and metabolic diseases. For this reason, Vital Solutions Swiss AG has started a research program elucidating the benefits of Careless for well-aging.

As we age, the function mitochondria, the power plant of cells, declines leading to disturbances in energy homeostasis, metabolism, and proper cell viability.

Emerging research revealed that energy homeostasis and related metabolic processes are steered by the evolutionary conserved metabolic sensors Sirt-1 (sirtuin-1) and AMPK (5`AMP-activated protein kinase) which respond to the increase in cellular AMP (adenosine monophosphate) and NAD+ (nicotinaminde adenine dinucleotide) concentrations. During exercise (energy depletion) or calorie restriction (lack of energy), Sirt-1 and AMPK are activated and hence stimulate a cascade of metabolic processes that “instruct” the body to start burning energy and stop storing it. AMPK activation results e.g. in increased fatty acid oxidation, inhibition of cholesterol, fatty acid and triglyceride synthesis, enhanced muscle glucose uptake and modulation of insulin secretion [6, 7]. Sirt-1 stimulates similar processes related to glucose, insulin and lipid metabolism as well as those related to increased stress resistance (see Figure 1) [8]. Together these players are suggested to explain many of the beneficial effects of physical activity and dietary interventions known to improve metabolic fitness as well as to help prevent metabolic diseases [9].

By Christina Ehrhardt and Dr. Sybille Buchwald-WernerVital Solutions Swiss AG, Hauptstr. 137C, CH-8274 Tägerwilen, Switzerland


Figure 1: Suggested metabolic benefits related to Sirt-1 activation.

Careless has recently been shown in vitro to activate both Sirt-1 and AMPK underlining the potential of the ingredient for well-aging concepts. Besides its beneficial effects on key energy sensors, Careless has anti-inflammatory properties as demonstrated by an attenuation of the release of inflammatory cytokine interleukin-6 (IL-6) in macrophages. Moreover, Careless has inhibited cyclo-oxigenase 1 an enzyme responsible for the formation of prostaglandins and thromboxanes. Inflammation as a function of aging has been well characterized in numerous epidemiological studies. Levels of inflammatory mediators increase with age even in the absence of acute infection or physiologic stress. Multiple inter-related mechanisms contribute to age-related inflammation with oxidative stress being one stimulator of chronic inflammation. Careless does not only have a good anti-oxidative capacity but may also contribute to an improved oxidative stress resistance via its Sirt-1 activating effects. Sirt-1 is known to stimulate the expression of anti-oxidants and to inhibit NF-ƙB signaling, a major inducer of inflammatory responses [6].

Last but not least, the potential of Careless to activate Sirt-1 and AMPK may contribute to the promotion of health during aging by supporting mitochondrial biogenesis. Sirt-1 and AMPK have been shown to stimulate PGC-1alpha, a master regulator or mitochondrial biogenesis [9]. Effective mitochondrial biogenesis and turnover is critical for the maintenance of energy production, the prevention of oxidative stress and well-aging [10]. In muscle cells for instance, mitochondrial biogenesis is related to improved muscle aerobic capacity, endurance and muscle mass [11].

In all, interventions that maintain or improve the activity of AMPK and Sirt-1 may help prevent the deleterious changes of aging including negative changes in body composition, reduced physical energy, and increased risk for chronic diseases such as type 2 diabetes and cardiovascular disease. Careless is a promising candidate to positively affect

well-aging by stimulating exactly these key metabolic sensors.Technological aspectsCareless is a high quality, sustainable, fine yellowish powder obtained from mango fruit, Mangifera indica L.. The production facility and manufacturing process complies with the highest international standards of safety, hygiene and quality control: ISO-9001:2008, ISO-22000:2005. Due to its fruity taste and brilliant yellow-orange color, Careless can be nicely used as functional ingredient in foods and food supplements including non-masking formulations like chewing gums which provide to consumers the healthy element in combination with a great food experience.

Conclusion and outlookCareless is a natural, IP protected healthy innovation for well-aging products. Based on in vitro evidence, Careless may help attenuate the negative metabolic changes associated with aging while delivering the pleasure and taste of exotic mango. The metabolic and anti-inflammatory effects of Careless benefit consumers at any age and suggest product concepts not only for the maintenance of muscle mass and physical energy, but also for the reduction of the risk for metabolic age-associated diseases, as well as cell protection.

Literature[1] WHO 2012: Interesting facts about aging. http://www.who.int/ageing/about/facts/en/#; 18.08.2014[2] Euromonitor: http://blog.euromonitor.com/2014/01/ageing-related-food-and-drink-focus-on-lengthening-healthy-life-expectancy.html; 21.08.2014[3] Tharanathan R.N. et al. Food Reviews International 2006,22, 95-123.[4] Shah K.A. et al. Pharmacognosy Review 2010, 4 (7), 42-8. [4] Yu H.C. , Kosuna K., Haga M. (eds), Perilla – The Genus Perilla, Harwood Academic Publishers, Amsterdam, 1997[5] Scartezzini P. et al. J. Ethnopharmacol. 2000, 71 (1-2), 23-43.[6] Salminen A and Kaarniranta K. AMP-activated protein kinase (AMPK) controls the aging process via an integrated signaling network. Ageing Res Rev 2012; 11: 230-241[7] Zhang BB, Zhou G, Li C. AMPK: an emerging drug target for diabetes and the metabolic syndrome. Cell Metab 2009; 9(5):407-16[8] Nogueiras R et al. Sirtuin 1 and sirtuin 3: physiological modulators of metabolism. Physiol Rev 2012; 92(3): 1479-1514[9] Canto C and Auwerx A. PGC-1alpha, SIRT1 and AMPK, an energy sensing network that controls energy expenditure. Curr Opin Lipidol 2009; 20(2): 98-105[10] López-Lluch G et al. Mitochondrial biogenesis and healthy aging. Exp Gerontol 2008; 43(9): 813-9[11] Hood DA. Crosstalk between oxidative stress and SIRT1: impact on the aging process. Int J Mol Sci 2013; 14: 3834-59

By Michelle Braun, Sr. Research Investigator - Protein Solutions

Many of these consumers prefer the use of foods and drinks that enhance their health over medications. In fact, there is a distinct opportunity within a sub-segment of this age group who have high nutritional awareness, are highly motivated to change, have health concerns and are looking for food, beverage and supplements to help. Meeting the nutrition needs of these early adopters who select foods and beverages to promote health as well as motivating them to action is vital.

As the population ages, the prevalence of overweight and obesity is also increasing, globally. The World Health Organization predicts there will be 2.3 billion overweight adults in the world by 2015 and more than 700 million of them will be obese2. A recent analysis of the National Health and Nutrition Evaluation Surveys (NHANES) data indicated that in the US in 2010, an estimated 73.5 percent of all women and 76.5 percent of all men aged 60 years or older were either obese or overweight, exceeding the average rate (69.2 percent) for adults of all age groups3. Aging is associated with body composition changes, with a tendency towards increased adiposity and decreased lean body mass4.

Dietary strategies for increasing satiety for weight managementIn most weight loss studies or programs, people are able to lose some weight with calorie restricted diets but many experience hunger pangs because they may not be given adequate macronutrients to support satiety, or the feeling of fullness, associated with the delay in consumption of the next eating occasion. Strategies for weight management also affect gut hormones as potential targets for metabolic appetite regulation5. There is also the need to lose abdominal fat, which is the biologically active fat linked to metabolic disorders such as diabetes and metabolic syndrome. An additional factor during weight loss and weight management is the need to maintain lean body mass, including muscle tissue. Losing muscle may equal greater weight loss, but in the long run the loss of muscle will lead to other issues such as decreased strength and mobility, a key area of concern among aging adults.

Both fiber and protein are integral parts of foods to support weight management. Dietary protein and fiber can affect appetite, promote satiety, and ultimately serve as valuable nutrients for healthy weight management.

Fiber intake has been associated with satiety and less weight gain. Dietary fiber can increase satiety and reduce short-term energy intake largely in part by adding bulk to foods, thereby reducing its energy density. Fiber-containing foods may also increase satiety by requiring the individual to spend more

Healthful ingredients . . . that address the major health concerns of aging consumers

In 2013, over 2.5 billion people worldwide were aged 40+ years. That number is projected to reach 3.5 billion by 2030, representing 42 percent of the population1. The fastest growing sector will be aged 60+ years, as the segment of the population aged 40+ years continues to rise1.Today’s aging consumer comes in many shapes and sizes. Therefore, marketing to consumers based on age alone will not lead to success. It is essential to appeal to consumers in this age bracket based on their needs, not based on a number alone.


time chewing to break down the food as well as prolonging gastric emptying and influencing the production of gut satiety hormones.

Polydextrose is a fiber composed of random linked glucose moieties, and an accumulation of evidence support its capacity to suppress appetite. A recent study shows that subjective feelings of appetite can be reduced after consumption of a polydextrose-containing product6. In addition, several studies have consistently shown that polydextrose is able to reduce the caloric intake in a subsequent meal6-9. All these effects were observed at relatively low and practical doses: 6.3g, 12.5g and 25g of polydextrose.

Research provides compelling evidence that diets high in protein increase satiety more than high-carbohydrate diets, thereby curbing food intake and aiding weight loss and weight management10-14. Evidence also suggests that high protein diets tend to preserve more lean body mass than high carbohydrate diets during weight loss. Soy, a vegetable-based source of high quality protein, has the potential to help individuals with body weight control. The low fat, no cholesterol, widely available soy protein has been found to be as effective as other high-quality proteins at increasing satiety and aiding weight loss and offers the additional advantage of improving cardiovascular risk factors. A healthy diet containing adequate protein may help people reduce energy intake, and fat mass during weight loss. In addition, high quality soy protein can help preserve muscle mass that is often lost during weight loss.

Whether achieved through consumption of protein or fiber, the feeling of satiety that both convey can be interpreted as satisfaction by an individual consuming a calorie restricted or weight loss diet. An increase in satiety with the corresponding decrease in hunger can support a reduction of daily caloric intake15. Over time, this may translate into potential meaningful changes in body weight or body composition, as well as quality of life16.

Satiety and maintaining energy balance are key factors for healthy weight management, for people of any age. Maintaining a healthy weight is of additional importance for people who are 40+ and 60+, but for slightly different reasons. Overweight and obesity are recognized as risk factors for a number of diseases that may onset after age 40, such as type 2 diabetes, high blood cholesterol, high blood pressure, heart disease, stroke, cancer, nonalcoholic fatty liver disease and metabolic syndrome — a combination of high blood sugar, high blood pressure, high triglycerides and low HDL cholesterol. Recent reviews have shown that consuming foods with a lower glycemic index is also an effective way to promote weight loss.

Fiber and protein can help support normal blood glucose levelsAn important consideration when seeking foods and beverages to support normal blood glucose levels is the glycemic index, which is the value given to a food based on its ability to raise blood glucose. A glycemic index (GI) of 100 would be the equivalent of consuming pure glucose whereas something with very little carbohydrate content would have a low GI. Foods classified as high GI acutely raise the blood glucose more than medium or low GI foods. High GI foods contain rapidly digested and absorbed carbohydrates that lead to a sharp rise in blood glucose after they are eaten. Glucose is released more gradually into the blood and yield a lower increase in blood glucose after eating a low GI food.

Polydextrose, soy fiber and soy protein can be used in combination with or to replace high glycemic carbohydrates to lower the glycemic index of a particular food. In fact, polydextrose has a very low GI (4-7) and was originally developed for use by diabetics17, 18. Studies have shown that an added 12-14 g of polydextrose ingested together with glucose lowers the glycemic response to the carbohydrate compared to the same amount of carbohydrate without polydextrose19, 20. These results indicate that polydextrose lowers the glycemic response, even when the carbohydrate

load is not reduced. It has been hypothesized that polydextrose interferes with the release of glucose from the food matrix in the small intestine, which leads to a slower and lower increase in blood glucose concentration8.

Soy fiber and soy protein can lower the GI of a food when used in replacement of carbohydrates in a given formula. For example, a rice crisp bar that contains 2g of protein may have a GI of 97. When the same bar is made with soy protein crisps and has 22g of protein, the GI becomes 5721. Keeping fat and non-fiber carbohydrate content held constant, adding 20g of soy protein in this case lowers the glycemic index from 97 to 57, from high GI to medium GI classification. In addition, incorporating soy fiber into the bar would require less soy protein to significantly lower the glycemic index. A bar formulated with 5.5g of soy fiber and 7.5g of soy protein would lower the glycemic index from 97 to 6421.

The addition of soy protein in a test food in a meal, such as breakfast, can help to maintain healthy blood glucose response. In a randomized clinical study, 11 overweight or obese men with metabolic syndrome and insulin resistance consumed either a high glycemic, low protein breakfast or a low glycemic, high soy protein meal replacement11. Four hours after breakfast, all subjects consumed the same standardized lunch. In the first two hours after breakfast, the blood glucose levels were significantly lower after the intake of the high soy protein meal. Postprandial insulin responses were also lower following the high soy protein meal. These results, together with favorable effects on appetite-regulating hormones also observed in this study, could help explain the beneficial role of meal replacements high in soy protein for weight reduction and improvements in metabolic risk factors, such as blood glucose and insulin22.

Desperately seeking foods and beverages that provide energy benefitsSatiety is defined as a feeling or condition of being full after eating food, however, many times, consumers associate this feeling with other terms such as ‘energy’ or ‘getting through the day’. A common goal in most weight loss or weight maintenance programs is to eat less at the next meal or snack, and satiety plays an important role in achieving this goal. However, consumers also associate these sensations, and the nutrients that enhance satiety, such as protein, with energy.

Consumer products promising more energy have been on the rise in recent years. A steady level of glucose in your blood stream helps support mental concentration, among other things. When blood glucose levels spike and then drop, one may feel tired and unfocused. A key factor in maintaining a steady blood glucose level is to favor food products with a low GI23. Foods high in dietary fiber or protein often have a low GI24.

In summary, there is compelling evidence that diets high in protein and fiber increase satiety more than high-carbohydrate diets, thereby curbing food intake and aiding weight loss and weight management. The evidence indicates that high protein diets, as part of a calorie-reduced diet, tend to preserve more lean body mass during weight loss as well. Moreover, increasing fiber and protein in the diet can improve the GI of foods by displacing carbohydrates as well as improving blood lipid levels

Establishing healthy behaviors early in life is a major factor for maintaining a high quality of life throughout the aging process. It is commonly thought that aging begins at age 50 or 60, however, aging begins at birth. The aging population seems to be striving to practice a lifestyle which can help extend lifespan as well as accommodate more enjoyable years of life.

For more information visit www.food.dupont.com

References1. Euromonitor, 2014 2. World Health Organisation Fact Sheet No. 311. 2006.3. Flegal KM, Carroll MD, Kit BK, Ogden CL: Prevalence of obesity and trends in the distribution of body mass index among US adults, 1999-2010. JAMA 2012, 307:491-497.

4. Barzilai N, Huffman DM, Muzumdar RH, Bartke A: The critical role of metabolic pathways in aging. Diabetes 2012, 61:1315-1322.5. Trigueros L, Peña S, Ugidos AV, Sayas-Barberá E, Pérez-Álvarez JA, Sendra E. Food ingredients as anti-obesity agents: a review. Crit Rev Food Sci Nutr. 2013, 53(9):929-42. 6. Hull S, Re R, Tiihonen K, Viscione L, Wickham M. Consuming polydextrose in a mid-morning snack increases acute satiety measurements and reduces subsequent energy intake at lunch in healthy human subjects. Appetite. 2012, 59(3):706-12. 7. King NA, Craig SA, Pepper T, Blundell JE. Evaluation of the independent and combined effects of xylitol and polydextrose consumed as a snack on hunger and energy intake over 10 d. Br J Nutr. 2005, 93(6):911-5.8. Astbury NM, Taylor MA, Macdonald IA. Polydextrose results in a dose-dependent reduction in ad libitum energy intake at a subsequent test meal.Br J Nutr. 2013 Sep 14;110(5):934-42. 9. Ranawana V, Muller A, Henry CJ. Polydextrose: its impact on short-term food intake and subjective feelings of satiety in males-a randomized controlled cross-over study. Eur J Nutr. 2013 Apr;52(3):885-93. 10. Astrup, A. The satiating power of protein--a key to obesity prevention? Am J Clin Nutr. 2005, 82, 1-2.11. Halton, T. L.; Hu, F. B. The effects of high protein diets on thermogenesis, satiety and weight loss: a critical review. J Am Coll Nutr. 2004, 23, 373-385.12. Faipoux, R.; Tome, D.; Gougis, S.; Darcel, N.; Fromentin, G. Proteins activate satiety-related neuronal pathways in the brainstem and hypothalamus of rats. J Nutr. 2008, 138: 1172-8.13. Faipoux, R.; Tome, D.; Bensaid, A.; Morens, C.; Oriol, E.; Bonnano, L. M.; Fromentin, G. Yeast proteins enhance satiety in rats. J Nutr. 2006, 136: 2350-2356.14. Bensaid, A.; Tome, D.; Gietzen, D.; Even, P.; Morens, C.;

Gausseres, N.; Fromentin, G. Protein is more potent than carbohydrate for reducing appetite in rats. Physiol Behav. 2002, 75: 577-58215. Turner TF, Nance LM, Strickland WD, Malcolm RJ, Pechon S, O’Neil PM. Dietary adherence and satisfaction with a bean-based high-fiber weight loss diet: a pilot study. ISRN Obes. 2013:915415. 16. Hetherington MM, Cunningham K, Dye L, Gibson EL, Gregersen NT, Halford JC, Lawton CL, Lluch A, Mela DJ, Van Trijp HC. Potential benefits of satiety to the consumer: scientific considerations. Nutr Res Rev. 2013, 26(1):22-38. 17. McMahon, F.G. Polydextrose Food Additive Petition. FDA Petition 9A3441. 1978, Pfizer Inc., New York.18. Stowell, J.D. (2009). Polydextrose. In: Cho SS (ed) Fiber Ingredients: Food Applications and Health Benefits. Taylor & Francis, p. 173-201.19. Jie Z, Bang-Yao L, Ming-Jie X, Hai-Wei L, Zu-Kang Z, Ting-Song W, Craig SA. Studies on the effects of polydextrose intake on physiologic functions in Chinese people. Am J Clin Nutr. 2000,72(6):1503-9.20. Shimomura Y, Nagasaki M, Matsuo Y, Maeda K, Murakami T, Sato J, Sato Y. Effects of Polydextrose on the Levels of Plasma Glucose and Serum Insulin Concentrations in Human Glucose Tolerance Test. Journal of Japanese Association for Dietary Fiber Research 2004;8 (2) 105-109.21. Solae, internal data22. König D, Muser K, Berg A, Deibert P. Fuel selection and appetite-regulating hormones after intake of a soy protein-based meal replacement. Nutrition. 2012, 28(1):35-9. 23. Riccardi G, Rivellese AA, Giacco R. Role of glycemic index and glycemic load in the healthy state, in prediabetes, and in diabetes. Am J Clin Nutr. 2008, 87(1):269S-274S. 24. Brand-Miller JC, Stockmann K, Atkinson F, Petocz P, Denyer G. Glycemic index, postprandial glycemia, and the shape of the curve in healthy subjects: analysis of a database of more than 1,000 foods. Am J Clin Nutr. 2009, 89(1):97-105.



WHAT: Global Expo and Conference SupplySide WestWHERE: Mandalay Bay, Las VegasNeptune Booth No: 21125WHEN: Expo Hall: October 8-9, 2014WHO: Attendees of the show include:• Nutrition industry experts• Nutraceutical manufacturers and distributors• Retail store owners• Consumers interested in the latest nutritional ingredients and suppliersWHY: Play Football Frenzy and learn about Neptune’s new formulas

• NKO® Beat — Improving the Absorption of CoQ10 for Heart Health*NKO® Beat provides all the heart health benefits of NKO® plus added Coenzyme Q10 (CoQ10). CoQ10 is well-known and proven as a powerful antioxidant. A clinical trial has shown that when CoQ10 is combined with NKO® the CoQ10 absorption levels are greatly increased—demonstrating up to 25 times better absorption compared to a generic USP CoQ10.*

• NKO® Flex — Enhanced Bioaccessibility of Vitamin D for Superior Bone Health and Joint Comfort*NKO® Flex provides all the joint health and whole health benefits of NKO®’s high-bioavailability Omega-3, plus added vitamin D, strontium, and zinc. Combining high-potency vitamin D with NKO® results in up to two times increased digestion of vitamin D3. The NKO® Flex formula supports both joint comfort and bone health.*

• NKO® Focus — Brain and Vision Support*NKO® Focus provides all the brain and whole health benefits of NKO® premium, plus added lutein esters, thiamine (vitamin B1), and vitamin A. Targeted for women and men 40 years and older, the NKO® Focus formula addresses the often co-occurring health goals of supporting healthy brain function and maintaining healthy vision. Well-known and supported for its eye health benefits, lutein is a must in vision health supplements. When combined with NKO®, lutein’s absorption is improved by up to 8 times.*

• Jacqueline Khayat, Sales DirectorJacqueline Khayat, an international sales and health sciences expert, joins Neptune’s team. She brings with her more than a decade of sales experience and nutrition expertise to the firm best known for discovering and patenting the extraction process for Neptune Krill Oil®.

Play FOOTBALL FRENZY and WIN!** - DetailsParticipants will play the “NFL Two-Minute Drill” game testing their throwing accuracy. With two minutes on the clock, toss the balls as fast and accurately as possible to score points.Prizes will be given to the top five highest scores and will be announced at the booth on Thursday, Oct. 9th at 3:30 p.m. Winners do not need to be present at the announcement to win.

The prizes include:Grand Prize - Highest Overall Score:• 2 VIP tickets in a suite at Denver Broncos/Buffalo Bills game in Denver, CO on December 7th • Round trip airfare to Denver from an airport within the US• Two nights lodging at a downtown Denver hotel• Round trip transportation to and from the Denver airport

Runner Up Prizes — Next Five Highest Scores May Choose Between:• 1 year supply of Neptune Krill Oil®

• 3 NFL footballs autographed by John Elway• 1 NFL Denver Bronco jersey, autographed by John Elway

For more information about Neptune’s exciting plans at SupplySide West, contact Sabrina Di Blasio, Marketing Director at 450-687-2262, ext: 227, or email [email protected].

Neptune Introduces Football Frenzy, Krill Oil Formulas, and New Sales Director at SupplySide WestFootball Frenzy Grand Prize Includes Trip for Two to Denver and VIP Suite Tickets for Broncos Game Neptune Technologies & Bioressources, the krill oil pioneer, plans to light up Las Vegas during the SupplySide West Expo October 8th through the 9th at Mandalay Bay. Their Football Frenzy promotion will give participants a chance to win a round-trip for two to Denver, Colorado with VIP suite tickets for the NFL matchup between the Broncos and Buffalo Bills on December 7th.**

(Alternate: Runner up prizes include John Elway autographed footballs and jersey.)For more than 15 years, SupplySide West has been the world’s largest expo gathering of

ingredient suppliers and finished product manufacturers. Neptune will be one of 1,700 exhibitors at the show. They will be featuring their sought-after ingredient, Neptune Krill Oil (NKO®), at booth No. 21125 alongside three new condition-specific formulas: NKO® Beat, NKO® Focus, and NKO® Flex.

Additionally, Neptune’s new Sales Director Jacqueline Khayat will help roll out the Football Frenzy promotion complements of VIP suite tickets provided by John Elway and the Denver Broncos. Elway is the Vice President of Football Operations for the Broncos and a Neptune ambassador. He recently played a starring role in a Neptune video announcing the opening of a new plant.

Neptune’s Pre-Show Buzz for SupplySide West

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