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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 rates in Europe Deaths per 100,000 83–151 152–210 211–296 297–507 508–839 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 Major risk factors for coronary heart disease Modifiable risk factors Non-modifiable risk factors • Abnormal blood lipid levels • Increased age – – – – high total cholesterol high LDL cholesterol low HDL cholesterol high triglycerides • High blood pressure • Lifestyle factors smoking, physical inactivity, obesity, unhealthy diet • Gender • Family history • Ethnicity or race CHD mortality (age-adjusted per 1000 men in 6-years)1 Lower cholesterol levels associated with lower risk for coronary heart disease (CHD) 20 15 10 5 0 3.8 [147] 5.2 [201] 6.5 [251] Total serum cholesterol (mmol/l, [mg/dl]) 1. Martin et al. Lancet 1986 7.6 [294] Contribution of selected risk factors to coronary heart disease: high cholesterol a major factor 60 56% 49% 50 40 31% 30 22% 20 10 0 High blood cholesterol Low fruit & vegetable intake Suboptimal blood pressure systolic BP >115 mmHg Physical inactivity Mackay and Mensah, The atlas of heart disease and stroke, WHO 2004 Prevalence of elevated blood cholesterol globally Prevalence of high cholesterol (%)1 100 90 80 70 60 50 40 30 20 10 1. MONICA data: age-standardised, estimated from average men and women: Total cholesterol >5.0 mmol/l Tolonen et al. Int J Epidemiol 2005 China USA Russia Spain Poland Canada Italy Denmark Belgium UK France Sweden Czech Republic Germany Switzerland 0 Guidelines for desirable blood lipid levels 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 >40 mg/dl >1.2 mmol/l (46 mg/dl) female Triglycerides <1.7 mmol/l (150 mg/dl) <150 mg/dl 1. Third European Joint Task Force, De Backer Eur J Cardio Prev Rehab 2003 2. National Cholesterol Education Program Expert Panel, JAMA 2001 Cholesterol, plant sterols and stanols have similar structures HO HO Plant sterolCampesterol Cholesterol HO Plant sterolb-Sitosterol HO Plant stanolb-Sitostanol Plant sterols are natural components of the human diet Average daily intake of adults 150-400 mg/day (higher in vegetarians) Plant sterols… Old-timers Reduction of Blood Cholesterol in Man By 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 sterol esterification fatty acid HO sterol ester O C O Overview of clinical trials assessing efficacy of plant sterols plant sterols (g/d) LDL cholesterol (% change) 0 0.5 1 1.5 2 2.5 3 3.5 2–2.5 g of plant sterols daily significantly reduces LDL cholesterol by ~10% -4 -8 -12 -16 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 Substantial impact of plant sterol consumption on 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 • 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 Clinical Guidelines, International Atherosclerosis Society, 2003 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) 0 healthy diet* -10 healthy diet plant sterol-enriched foods ** healthy diet Statin treatment*** -20 -30 plant sterol-enriched foods -40 * low in saturated fat and cholesterol ** 2g/day *** based on average statin effects Based on: Katan et al. Mayo Clin Proc 2003; 78: 965–978 Edwards & Moore BMC Family Practice 2003; 4–18 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 pro.activ spread • 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 polyunsaturated fatty acids and low in saturated fatty acids • Can be used like any other low-fat spread • Virtually free from trans fatty acids pro.activ milk drink • Milk drink: – enriched with plant sterols – semi-skimmed milk drink (1.8% fat) – Can be used like any other semi-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 cholesterollowering: 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 Flora pro.activ performance Volume +50% Source: AC Nielsen MAT TO WE 26.02.05 vs MAT TO WE 25.02.06 Value +35% The CL market still showing strong growth with Unilever boasting over 58% share of the value. Chol Lowering Value Share by Manufacturer Danone 5.2% £8M 2K T McNeil 36.2% £53M 8K T Unilever 58.6% £85M 16K T