Plant Sterols – a product case study

Jacqui Morrell

Unilever nutritionist

Cardiovascular disease (CVD) is the leading cause of mortality worldwide

• 16.7 million deaths worldwide from CVD in 20021

– 7.2 million deaths from coronary heart disease

• 3.8 million men

• 3.4 million women

– 5.5 million deaths from stroke

• 2.5 million men

• 3 million women

1. Mackay and Mensah, The atlas of heart disease and stroke, WHO 2004

Coronary heart disease (CHD) mortality ratesin Europe

European cardiovascular disease statistics, 2005:Age-standardised death rates for men aged 35–74, latest year

CHD is the main cause of death in Europe

83–151

152–210

211–296

297–507

508–839

Deathsper 100,000

Major risk factors for coronary heart disease

Modifiable risk factors

• Abnormal blood lipid levels– high total cholesterol

– high LDL cholesterol

– low HDL cholesterol

– high triglycerides

• High blood pressure

• Lifestyle factorssmoking, physical inactivity, obesity, unhealthy diet

Non-modifiable risk factors

• Increased age

• Gender

• Family history

• Ethnicity or race

1. Martin et al. Lancet 1986

Lower cholesterol levels associated with lower risk for coronary heart disease (CHD)

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Total serum cholesterol (mmol/l, [mg/dl])

3.8 [147]

0

5

10

15

20

5.2 [201] 6.5 [251] 7.6 [294]

Contribution of selected risk factors to coronary heart disease: high cholesterol a major factor

Mackay and Mensah, The atlas of heart disease and stroke, WHO 2004

Low fruit & vegetable intake

Physical inactivity

High blood cholesterol

Suboptimal blood pressuresystolic BP >115 mmHg

22%

31%

49%

56%

0

10

20

30

40

50

60

Prevalence of elevated blood cholesterol globally

1. MONICA data: age-standardised, estimated from average men and women:Total cholesterol >5.0 mmol/l Tolonen et al. Int J Epidemiol 2005

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Guidelines for desirable blood lipid levels

1. Third European Joint Task Force, De Backer Eur J Cardio Prev Rehab 20032. National Cholesterol Education Program Expert Panel, JAMA 2001

European Guidelines1 NCEP Guidelines2

Total cholesterol <5.0 mmol/l (190 mg/dl) <200 mg/dl

LDL cholesterol <3.0 mmol/l (115 mg/dl) <100 mg/dl

HDL cholesterol >1.0 mmol/l (40 mg/dl) male

>1.2 mmol/l (46 mg/dl) female

>40 mg/dl

Triglycerides <1.7 mmol/l (150 mg/dl) <150 mg/dl

Cholesterol, plant sterols and stanols have similar structures

HO HO

HO

HO

Cholesterol

Plant sterol--Sitosterol

Plant sterol-Campesterol

Plant stanol--Sitostanol

Plant sterols are natural components of the human diet

Average daily intake of adults150-400 mg/day

(higher in vegetarians)

Plant sterols… Old-timers

Reduction of Blood Cholesterol in ManBy O.J.POLLAK, M.D., Ph.D.

Dietary-cholesterol contributes to the development and maintenance of hypercholesterolemia in man. Intake of sitosterol prevents cholesterol resorption. This results in lowering of blood cholesterols to a basal endogenous levels. Upon cessation of sitosterol intake hemocholesterols return to the original level. Excess supply of plant sterol was required in clinical experiments because the material used contained but 75 to 80 per cent of sitosterol and because of the large amount of endogenous cholesterol which has to be inactivated by the sitosterol, besides exogenous cholesterol.

Circulation Volume VII. May 1953

Plant sterol-enriched food products: why use plant sterol esters?

• Esterification of plant sterols with fatty acids increases their solubility in food products

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Overview of clinical trials assessingefficacy of plant sterols

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plant sterols (g/d)

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41 trials with plant sterols/stanols: 95% CI from meta-analysis Katan et al. Mayo Clin Proc 2003

LDL cholesterol from pro.activ sponsored studies

2–2.5 g of plant sterols daily significantly

reduces LDL cholesterol by ~10%

Substantial impact of plant sterol consumptionon heart health

• Scientific evidence is sufficient to promote use of plant sterols for lowering LDL cholesterol levels in persons at increased risk for coronary heart disease

• Reduction in LDL cholesterol levels of about 10% could be expected to reduce the incidence of coronary heart disease by about 12–20% over 5 years

• Longer-term risk reduction would be about 20%

Expert Workshop: Katan et al. Mayo Clin Proc 2003

Dietary recommendations for prevention of coronary heart disease

Clinical Guidelines, International Atherosclerosis Society, 2003

• Saturated fat: <7% of total energy

• Trans fatty acids: low

• n-3 fatty acids: >1% of total energy (2–3 g/day)

• Dietary cholesterol: <200 mg/day

• Viscous fibre: ~10 g/day

• Fruits and vegetables: 5 servings daily

• Folic acid: 400–1000 µg/day

• Alcohol: <20–30 ml/day (men) and 10–20 ml/day (women)

• Consider plant stanol/sterol: 2 g/day

Therapeutic Lifestyle Changes (TLC) according to NCEP ATP III guidelines

Main features of the TLC:

• Weight reduction

• Increase physical activity

• Total fat intake: 25–35% total energy

• Reduce saturated fat and cholesterol intake:– saturated fat <7% total energy

– cholesterol <200 mg/day

• Option for enhancing LDL lowering:– plant sterols/stanols 2 g/day

– increased viscous, soluble fibre intake to 10–25 g/day

National Cholesterol Education Program Expert Panel, JAMA 2001

Cholesterol-lowering effect of plant sterols is additive to a healthy diet and to lipid-lowering

medication (statins)

* low in saturated fat and cholesterol** 2g/day *** based on average statin effectsBased on: Katan et al. Mayo Clin Proc 2003; 78: 965–978Edwards & Moore BMC Family Practice 2003; 4–18

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0healthy diet* healthy diet

plant sterol-enriched foods **

Statin treatment***

healthy diet

plant sterol-enriched foods

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Cholesterol-lowering with plant sterol-enriched foods

• Reproducible, robust effects

• Sustained with longer-term use

• Independent of the background diet (typical Western or low-fat)

• Proven compliance and efficacy in free-living populations (adults and familial hypercholesterolemia children)

• Additive effect to low saturated fat, low cholesterol lipid-lowering diet

• Additive effect to lipid-lowering medication (statins and fibrates)

• No adverse effect on HDL cholesterol

pro.activ product range

• 35% low-fat spread

• Enriched with plant sterols proven to reduce cholesterol

• Per 10 g serving: – 33 calories

– 0.75 g of sterols

• Made from vegetable oils

• High in polyunsaturatedfatty acids and low insaturated fatty acids

• Can be used like any other low-fat spread

• Virtually free from trans fatty acids

pro.activ spread

pro.activ milk drink

• Milk drink:– enriched with plant sterols

– semi-skimmed milk drink (1.8% fat)

– Can be used like any othersemi-skimmed milk

– Per 250 ml serving:

• 125 calories

• 0.75 g of plant sterols

pro.activ yoghurts

• Yoghurts:– enriched with plant sterols

– low-fat (0.5% fat)

– range of flavours

• Per 125 g pot:– 97–101 calories

(depending on flavour)

– 0.75 g of plant sterols

pro.activ yoghurt mini drinks

• Enriched with plant sterols

• Semi-skimmed yoghurt drink

• Contains probiotic Bifidobacterium lactis Bb12

• A range of flavours

• Per bottle:– 87 calories

– 2 g of plant sterols

Optimal daily plant sterol intake for cholesterol-lowering: servings or portions

• The plant sterols in 3 portions of pro.activ foods (or one yoghurt mini drink) are clinically proven to lower LDL (bad) cholesterol levels significantly

• 1 mini drink = 2 g plant sterols

• 3 portions of milk,spread, yoghurts = 2.25 g plant sterols

‘The most significant advancement in the dietary management of cholesterol in

thirty years’

Professor Leon Simons, Head of Lipids Department, St Vincent’s Cholesterol Clinic,

Australia, speaking on National TV news

Conclusions

• Cholesterol-lowering efficacy of plant sterol-enriched foods has been proven in more than 40 clinical studies. The results are reproducible and sustainable in the long-term

• The 10% reduction in LDL cholesterol levels can reduce the risk of coronary heart disease by up to 20%

• Plant sterol-enriched foods are safe, approved and endorsed internationally

• Plant sterols are recommended in dietary guidelines for cholesterol-lowering

Volume+50%

Value+35%

Flora pro.activ performance

Source: AC Nielsen MAT TO WE 26.02.05 vs MAT TO WE 25.02.06

Chol Lowering Value Share by Manufacturer

Danone5.2%£8M2K T

McNeil36.2%£53M8K T

Unilever58.6%£85M16K T

The CL market still showing strong growth with Unilever boasting over 58% share of the value.