Transcript
Page 1: Nutritional Supplement Research:  Beyond the Status Quo

Nutritional Supplement Research: Beyond the Status Quo

Page 2: Nutritional Supplement Research:  Beyond the Status Quo

• Background• What is the Status Quo?• Common Problems and Solutions

– Quality control– Dosing

Overview

Page 3: Nutritional Supplement Research:  Beyond the Status Quo

Background• Dietary Supplement Health and

Education Act of 1994 (DSHEA)

• DSHEA deregulation

• No GMP’s

• No quality control standards

• No requirement to show safety or efficacy

• The Office of Dietary Supplements (ODS) was established through DSHEA (by NIH in 1995) and collaborates with the National Center for CAM (NCCAM)

• ODS and NCCAM promote and award funding for scientific research on dietary supplements

Nesheim, Pub Health Nutr, 1999www.ods.od.nih.gov

Page 4: Nutritional Supplement Research:  Beyond the Status Quo

Table 1. Total number of projects and funding for the NIH and USDA top 10 dietary supplement ingredients in the CARDS database, FY 1999-2007

NIH USDA

Ingredient Projects, n

Funding, USD millions Projects,

n

Funding, USD millions

Vitamins and minerals 3197 1093 1443 294

Botanicals 1583 439 592 87

Phytochemicals 1470 415 697 123

Fatty acids and lipids 1051 304 685 130

Proteins and amino acids 597 156 229 45

Antioxidants 528 142 290 82

Dietary Fiber and carbohydrates

196 79 165 24

Hormones/precursors 185 57 10 1

Other 196 63 64 9

BackgroundRegan et al., J Nutr, 2010

$1.9 billion $347 millionNCCAM

$370 million

Page 5: Nutritional Supplement Research:  Beyond the Status Quo

áMitochondriaáMitochondrial

enzymes

IATask Area I

Year 1 12 months

> 20% changeTo Task II

Task Area IIIYear 2

18-24 months

IIIA IIIB IIIC IIID IIIEEndurance

PerformanceSoldier Task Performance

Muscle InjuryâInflammation

Cognitive Performance

Environmental Extremes

Performance

To Task IV Each > 20% change: IIIA or IIIB or IIIC or IIID or IIIE

Human Performance Testing

Task Area IV Field Testing Performance

Final Formulation Incorporation into Ration

Transition to Ration

Task Area IIYear 1

12 months

IIA IIB IIC IID

Bioavailability Dosing

HumanPharmacokinetics

AcceptableFormulation

AcceptableTo Task III Achieved Completed Hedonics > 6

Analysis FRS Components

áMitochondriaáMitochondrial

enzymes

IATask Area I

> 20% changeTo Task II

áMitochondriaáMitochondrial

enzymes

IAáMitochondriaáMitochondrial

enzymes

IA

Task Area I

12

> 20% changeTo Task II

Task Area IIIYear 2

18-24 months

IIIA IIIB IIIC IIID IIIEEndurance

PerformanceSoldier Task Performance

Muscle InjuryâInflammation

Cognitive Performance

Environmental Extremes

Performance

To Task IV Each > 20% change: IIIA or IIIB or IIIC or IIID or IIIE

Human Performance Testing

Task Area IIIYear 2

18-24 months

IIIA IIIB IIIC IIID IIIEEndurance

PerformanceSoldier Task Performance

Muscle InjuryâInflammation

Cognitive Performance

Environmental Extremes

Performance

To Task IV Each > 20% change: IIIA or IIIB or IIIC or IIID or IIIE

Task Area IIIYear 2

18-24 months

IIIA IIIB IIIC IIID IIIEEndurance

PerformanceSoldier Task Performance

Muscle InjuryâInflammation

Cognitive Performance

Environmental Extremes

Performance

To Task IV Each > 20% change: IIIA or IIIB or IIIC or IIID or IIIE

Human Testing

Task Area IV Field Testing Performance

Final Formulation Incorporation into Ration

Transition to Ration

Task Area IV Field Testing Performance

Final Formulation Incorporation into Ration

Transition to Ration

Task Area IIYear 1

12 months

IIA IIB IIC IID

Bioavailability Dosing

HumanPharmacokinetics

AcceptableFormulation

AcceptableTo Task III Achieved Completed Hedonics > 6

Analysis FRS Components

Task Area IIYear 1

12 months

IIA IIB IIC IID

Bioavailability Dosing

HumanPharmacokinetics

AcceptableFormulation

AcceptableTo Task III Achieved Completed Hedonics > 6

Task Area IIYear 1

12 months

IIA IIB IIC IID

Bioavailability Dosing

HumanPharmacokinetics

AcceptableFormulation

AcceptableTo Task III Achieved Completed Hedonics > 6

Analysis FRS Components

What is the Status Quo?

Slide provided courtesy of Dr. Ed Zambraski, USARIEM

Ideal?

Page 6: Nutritional Supplement Research:  Beyond the Status Quo

What is the ‘Status Quo?’

Source of Supplement?: Usually off-the-shelf

Verification of quality?: Usually not

Dose?: Usually what others have used

Kinetics/bioavailability?: Usually not

Study design?: Usually good!

Data analysis?: Conventional and sound

Data display & interpretation?: Usually marginal or poor

Reality?

Page 7: Nutritional Supplement Research:  Beyond the Status Quo

Quality Control(Problem - Dissolution)

• > 50% of calcium supplements

and many single and

multivitamin-mineral

preparations fail to meet USP

disintegration and dissolution

standards.

• > 40% of melatonin

supplements fail to meet USP

disintegration standards.Carr and Shangraw, Am Pharm, 1987 (adapted from Table 3)

Carr and Shangraw, Am Pharm, 1987; Shangraw, Pub Health Rep Suppl, 1990;Hahm et al., J Am Pharm Assoc, 1999

Page 8: Nutritional Supplement Research:  Beyond the Status Quo

Quality Control(Problem - Content)

Gurley et al., Am J Health Syst Pharm, 2000Harkey et al., Am J Clin Nutr, 2001Parasrampuria et al., JAMA 1998Green et al., Clin J Sports Med, 2001Andrews et al., Anal Bioanal Chem, 2007

Pharmaceutical Standard (USP)

Ephed

ra

Ginsen

g

DHEA

Sterio

ds

Caffe

ine

0

50

100

150

200

250

300

% L

abel

Cla

im

Page 9: Nutritional Supplement Research:  Beyond the Status Quo

• Good Manufacturing Practices (GMP) provide a system of processes, procedures, and documentation to assure a product has the identity, strength, composition, quality, and purity that it claims.

• Three independent non-governmental programs provide GMP guidelines for dietary supplements.

• Adoption is VOLUNTARY

Natural ProductsAssociation (NPA GMP)

NSF GMP

USP Dietary Supplement Verification Program

Quality Control(Solution)

Page 10: Nutritional Supplement Research:  Beyond the Status Quo

Quality ControlA word about mixtures (cocktails) or “Product Testing”

Effects (or lack of effects) observed using multiple ingredients violates basic scientific philosophy.

There is no way to know if the ingredients (or which ingredients) are acting synergistically, antagonistically, or if they are biologically active at all.

> 100 interactions possible between ingredient pairs; > than 1,000,000 interactions possible among random groupings

SuperStuff5000

5x stronger than our 1000 formula!

Ingredient List:

Chinese Ginseng, SiberianGinseng, Vitamin B-12, Guarana,Yohimbine, L-Carnitine, Bee Pollen, Caffeine, Ginkgo Biloba (leaf), Coenzyme Q10, DHEA, SAMe, Fish Oil, Quercetin, Glucosamine Chondroitin, FD&C Green #2 .

Product Claims:

• Boost Immunity• Reverse Male-Pattern Baldness• Burn Fat• Improve Memory• Increase Energy• Enhance Labido


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