Download The facts about cardiovascular disease

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