Klinické dôkazy o účinnosti Flora pro.activ

EFFICACY OF PLANT STEROL* ENRICHED FOODS

Plant sterol-enriched margarines and reduction of plasma total- and LDL-cholesterol concentrations in normocholesterolaemic and mildly hypercholesterolaemic subjects.
Weststrate JA et al., Eur J of Clin Nutr. 1998; 52(5): 334-343.
In a randomized, double-blind, placebo-controlled study, 95 healthy normocholesterolaemic or mildly hypercholesterolaemic subjects consumed 30 g plant sterol-enriched spread daily (3.2 g plant sterols/day) as part of their normal diet over a 3.5 week period. Using regular Flora/Becel as a control spread, plasma total-and LDL-cholesterol concentrations were reduced by 8% and 13% respectively without affecting HDL-cholesterol concentrations.

Spreads enriched with three different levels of vegetable oil sterols and the degree of cholesterol lowering in normo-cholesterolaemic and mildly hypercholesterolaemic subjects.
Hendriks HFJ et al., Eur J of Clin Nutr. 1999; 53(4): 319-327.
The dose response relationship between cholesterol lowering and intake of plant sterols was investigated in this randomized double-blind placebo-controlled study of 100 subjects using three experimental spreads fortified with three different concentrations of plant sterols. The intake of plant sterols was 0.8 g, 1.6 g or 3.2 g/day taken in 25 g spread/day over a 3.5 week period. Again, using regular Flora/Becel as a control, the average LDL-cholesterol reduction achieved as a result of enriching the spread with different plant sterols dosages was 6.7%, 8.5% and 9.9% respectively. These three dosages of plant sterols significantly reduced LDL-cholesterol.

Modulation of plasma lipid levels and cholesterol kinetics by phytosterol versus phytostanol esters.
Jones PJ et al., J Lipid Res. 2000; 41(5): 697-705.
In a randomized, crossover, double-blind study of 15 hypercholesterolaemic males using 1.8 g of plant sterols/stanols per day (23 g spread) as part of a healthy diet, effects on plasma cholesterol, cholesterol absorption and synthesis were determined. After 3 weeks of consuming the plant sterol enriched spread there was a significant 13% LDL-cholesterol reduction and for plant stanols a 6% LDL-reduction. The plant sterol and stanol esters lowered circulating total- and LDL-cholesterol by suppression of cholesterol absorption (- 36% for sterol and - 26% for stanol spread) and enhanced cholesterol synthesis. Both spreads are efficacious in reducing circulating cholesterol concentrations in hypercholesterolemic subjects.

Lipid responses to plant sterol enriched reduced fat spreads incorporated into a National Cholesterol Education Program Step I diet.
Maki KC et al., Am J Clin Nutr. 2001; 74(1): 33-43.
A randomized, double-blind, placebo controlled, 3 group parallel design study of 224 subjects with an initial LDL-cholesterol level between 3.4 and 5.2 mmol/l over a 5 week study period. Subjects followed a low fat Step I diet from the National Cholesterol Education Programme (NCEP). The groups received 14g of reduced-fat spread either a enriched with a low dose plant sterol esters (1.1 g plant sterols/day) or a higher dose (2.2 g plant sterols/day), or the control spread. Subjects in the low- and high-sterol groups who consumed ?80% of the scheduled servings had total cholesterol reductions of 5.2% and 6.6%, and LDL-cholesterol reductions of 7.6% and 8.1% respectively. This study shows that a reduced-fat spread containing plant sterol esters incorporated into a low fat NCEP diet is a beneficial adjunct in the dietary management of hypercholesterolemia.

Randomized controlled trial of use by hypercholesterolaemic patients of a vegetable oil sterol-enriched fat spread.
Neil HAW et al., Atherosclerosis 2001; 156(2): 329-337.
A randomized, double-blind, placebo-controlled, crossover trial over two 8 week periods was undertaken in 58 subjects with hypercholesterolaemia. The intake of spread was 25 g/day (2.5 g plant sterols/day). Significant LDL-cholesterol reduction from plant sterol enriched spread was 14% at 4 weeks and 10% at 8 weeks compared to control. No difference in the response between hypercholesterolaemic patients prescribed statins and those not taking lipid-lowering drug therapy was observed. This study concludes that plant sterols may be a useful additive therapy in the treatment of hypercholesterolaemic patients.

Plant sterol enriched margarine lowers plasma LDL-cholesterol? in hyperlipidemic subjects with low cholesterol intake: effect of fibrate treatment.
Nigon F et al., Clin. Chem. Lab. Med. 2001; 39(7): 634-40.
A randomized, double-blind placebo-controlled two period cross-over trial with 53 hypercholesterolemic patients with or without fibrate treatment. The aim of the study was to test the cholesterol lowering effect of a plant sterol enriched spread in hypercholesterolemic subjects and to test the combined effect with cholesterol lowering drugs (fibrates). Plasma total and LDL-cholesterol concentrations were significantly reduced by 6.4% and 8.8% respectively, for plant sterol enriched spread (intake 1.6 g /day) compared to control margarine. When subjects were divided in two subgroups according to fibrate treatment, plant sterol supplementation decreased plasma total and LDL-cholesterol by 8.5% and 11.1% respectively in the subgroup treated with fibrates. In the subgroup who did not receive fibrates, the total and LDL-cholesterol was reduced by 5.5% and 7.7% respectively. This study shows that plant sterol ester-enriched spread is a useful adjunctive therapy for hypercholesterolemic patients on fibrate treatment.

Effect of plant sterol-enriched margarine on plasma lipids and sterols in subjects heterozygous for phytosterolaemia.
Stalenhoef AF et al., J. Intern. Med. 2001; 249(2): 163-166.
In a 4-week study 2 subjects heterozygous for sitosterolemia received a diet that included 40g plant sterol enriched spread (3 g plant sterols /day). Total plasma cholesterol levels were decreased by 11 and 12% respectively, mainly due to a decrease in LDL-cholesterol. Plasma concentrations of plant sterols remained at similar levels as found in normal subjects.

Food phytosterol ester efficiency on the plasma lipid reduction in moderate hypercholesterolemic subjects.
Lottenberg AM et al., Arq Bras Cardiol. 2002; 79(2): 139-142 (Journal in Portuguese).
In a double blind crossover study, 60 moderate hypercholesterolemics received 20 g/day of a plant sterol enriched spread (containing 1.68 g plant sterols/day) and a control spread during 3 periods of 4 weeks. Total cholesterol and LDL-cholesterol concentrations levels were significantly reduced by 10% and 12%, respectively, in relation to base-line, and by 6% and 8% in relation to placebo treatment. In conclusion, treatment of plant sterol enriched spread reduced cholesterolemia.

An increase in dietary carotenoids when consuming plant sterols or stanols is effective in maintaining plasma carotenoid levels.
Noakes M et al., Am J Clin Nutr. 2002; 75(1): 79-86.
A double-blind, randomized crossover trial in 46 hypercholesterolemic subjects. This trial compared the efficacy of 25g of plant sterol and plant stanol ester enriched spread on plasma cholesterol and the effect on plasma carotenoid concentrations. Subjects were advised to eat at least 5 servings of fruit and vegetables daily, with at least one of the servings as carotenoid-rich carrots, sweet potato, pumpkin, tomato, apricots, spinach or broccoli. The sterol ester enriched spread (2.3 g sterols/day) significantly lowered LDL-cholesterol by 7.7% compared to control. The plant stanol enriched spread (2.5 g stanols/day) significantly lowered LDL-cholesterol by 9.5% compared to the control spread. There was no difference in cholesterol lowering between the spreads and no difference in plasma carotenoids compared with baseline. The advice to increase of fruit & vegetable intake was effective in maintaining plasma carotenoid levels within baseline values while lowering LDL-cholesterol concentrations.

Plant sterol ester-enriched spread lowers plasma total and LDL-cholesterol in children with familial hypercholesterolemia.
Amundsen AL et al., Am J Clin Nutr. 2002; 76(2): 338-344.
In a randomized, double-blind, controlled crossover study lasting for two 8 week periods, 38 children aged 7-12 years with familial hypercholesterolaemia consumed 18.2 g plant sterol-enriched spread daily (1.5 g plant sterols/day), achieving an average LDL-cholesterol reduction of 10.2% compared to control. In this important study, it was shown that children with familial hypercholesterolaemia already following a cholesterol lowering diet, can achieve an additional reduction in LDL-cholesterol of about 10% without any adverse effects from a daily intake of ~1.5 g plant sterols as plant-sterol enriched spread. This effect persisted in an open-label six months follow-up period in free living conditions simulating normal behaviour (see Amundsen et al., 2004).

A dietary portfolio approach to cholesterol reduction: combined effects of plant sterols, vegetable proteins, and viscous fibers in hypercholesterolemia.
Jenkins DJ et al., Metabolism. 2002; 51(12): 1596-1604.
In this study the combined effect of plant sterols, soy proteins, viscous fibers and almonds on blood lipids was tested in 13 hyperlipidemic subjects who were already consuming a low-saturated fat, low-cholesterol diet before starting the study. The intake of spread used was 24 g/day containing approximately 2 g plant sterols/day. After 4 weeks the portfolio diet reduced LDL-cholesterol by 29% and the ratio of LDL-cholesterol to HDL-cholesterol by 26.5%. Near maximal effects were seen by week 2. This study shows that acceptable diets of foods from food retailers containing a combination of recognised cholesterol-lowering dietary components may be as effective as the starting dose of older first-line drugs in managing hypercholesterolemia.

Effects of phytosterol ester-enriched margarine on plasma lipoproteins in mild to moderate hypercholesterolemia are related to basal cholesterol and fat intake.
Mussner MJ et al., Metabolism. 2002; 51(2): 189-194.
In this randomized, double-blind, placebo-controlled, cross-over study the effect of a 20g/day phytosterol ester-enriched spread (1.82 g plant sterols/day) on plasma lipoproteins after 3 weeks was investigated in 63 healthy subjects. Phytosterol ester-enriched spread significantly reduced total cholesterol by 3.4% and LDL-cholesterol by 5.4% compared with control. The findings of this study suggest that through lowering total and LDL-cholesterol the daily consumption of a phytosterol ester-enriched margarine may lower the risk of atherosclerosis in subjects with mild to moderate hypercholesterolemia. A spread enriched with plant sterol-esters lowers blood cholesterol and lipoproteins without affecting vitamins A and E in normal and hypercholesterolemic Japanese men and women. Ntanios FY et al. J Nutr; 2002; 132(12): 3650-3655. The efficacy of a plant sterol-ester enriched spread (15 g/day containing 1.8 g free sterols) in lowering blood cholesterol was examined in 53 Japanese volunteers consuming a traditional Japanese (low fat) diet. Plasma total and LDL-cholesterol concentrations were decreased by 5.8 and 9.1%, respectively, when subjects consumed the plant sterol enriched-spread than when they consumed the control spread. This study shows that patients already on a low fat diet can reduce their LDL-cholesterol further by introducing a plant sterol-enriched spread into their traditional Japanese diet.

Additive effect of plant sterol-ester margarine and cerivastatin in lowering low-density lipoprotein cholesterol in primary hypercholesterolemia.
Simons LA et al., Am J Cardiol. 2002; 90(7): 737-740.
In this multi-center, randomized double blind study, the additive or interactive effect of sterol ester-enriched margarine (25g containing 2 g plant sterol/day) in combination with a statin drug on LDL-cholesterol reduction was investigated in 152 primary hypercholesterolemic subjects. Cerivastatin (vs. placebo) reduced LDL-cholesterol by 32% and sterol ester-enriched margarine (vs. regular margarine) by 8%. The effect of sterol ester-enriched margarine and cerivastatin together on LDL-cholesterol reduction was additive (39%), but there was no significant interactive effect. The addition of a sterol ester-enriched margarine to statin therapy offers LDL-cholesterol reduction equivalent to doubling the dose of statin.

Effects of a plant sterol-enriched spread on serum lipids and lipoproteins in mildly hypercholesterolaemic subjects.
Temme EH et al., Acta Cardiol. 2002; 57(2): 111-115.
In this randomized double-blind placebo-controlled cross-over study the effects of plant sterol-enriched spreads (25 g containing 2 g plant sterol/ day) were determined on serum lipids, lipoprotein and apolipoprotein concentrations in 42 Belgian subjects. Serum total and LDL-cholesterol concentrations significantly reduced by 7% and 10%, respectively with the plant sterol-enriched spread compared to the control spread. These findings indicate that a daily intake of 25 g low-fat spread containing 2 g plant sterol per day is effective in lowering blood total and LDL-cholesterol.

Plant sterol-enriched spread enhances the cholesterol-lowering potential of a fat-reduced diet. Cleghorn CL et al.,
Eur J Clin Nutr. 2003; 57(1): 170-176.
In this randomized double-blind cross-over study, the effect of plant sterol enriched spread on plasma cholesterol concentrations when replacing butter or a standard polyunsaturated spread in a diet containing 30% of energy as fat was investigated. Fifty free-living men and women consumed 25 g of polyunsaturated spread with or without 2 g of plant sterols daily over 4 weeks. Replacing butter with a plant sterol-enriched spread reduced plasma total cholesterol by 8.9% and LDL-cholesterol by 12.3%. In people with moderately raised plasma cholesterol concentrations consuming reduced-fat diets the reduction in plasma total and LDL-cholesterol concentrations achieved by replacing butter with a polyunsaturated spread is enhanced by the addition of plant sterols.

Safety of long-term consumption of plant sterol esters-enriched spread.
Hendriks HFJ et al., Eur J of Clin Nutr. 2003; 57(5): 681-692.
The efficacy and safety of long-term consumption of spreads containing plant sterol esters are evaluated in a randomized double-blind placebo controlled parallel trial. One hundred and eighty-five healthy volunteers consumed daily 20 g spread enriched with 1.6 g plant sterols as fatty acid esters or a control spread for 1 year. Consumption of the plant sterol-enriched spread consistently lowered total and LDL-cholesterol during the 1 year period on average by 4 and 6%, respectively. This study concludes that the consumption of plant sterol-enriched spread is safe to use over a long period of time and an effective way to consistently lower blood cholesterol concentrations.

Effects of a dietary portfolio of cholesterol-lowering foods vs. lovastatin on serum lipids and C-reactive protein.
Jenkins DJ et al., JAMA. 2003; 290(4): 502-510.
In this 4-week randomized controlled trial 46 hyperlipidemic adults were assigned to 1 of 3 interventions: a very low-saturated fat diet (control), the same diet plus lovastatin, or a diet high in plant sterols, soy protein, viscous fibers, and almonds (dietary portfolio). LDL-cholesterol concentrations decreased by 8.0% in the control group, by 30.9% in the statin group, and by 28.6% in the dietary portfolio group. This data confirms that use of diets low in saturated fat together with plant sterols and viscous fibers, soy protein and nuts can greatly enhance the cholesterol lowering effect of dietary intake.

The effect of combining plant sterols, soy protein, viscous fibers, and almonds in treating hypercholesterolemia.
Jenkins DJ et al., Metabolism. 2003;52(11):1478-83.
In this study aimed to assess the contribution of reduced saturated fat and dietary cholesterol to the plasma lipid lowering seen with the portfolio diet. Twenty-five hyperlipidemic subjects consumed either a portfolio diet (n=13) which is very low in saturated fat and high in plant sterols (1.2 g/1000 kcal), soy protein, viscous fibers, and almonds, or a low-saturated fat diet (n=12). LDL-cholesterol was significantly reduced by 12% on the low-fat diet and by 35% on the portfolio diet. The reduction in LDL-cholesterol was significantly lower on the portfolio diet than on the control diet . Combining a number of foods and food components in a single dietary portfolio may lower LDL-cholesterol similarly to treatment with first-generation statins and can thus increase the potential effectiveness of dietary therapy.

A phytosterol-enriched spread improves the lipid profile of subjects with Type 2 diabetes mellitus. A randomized controlled trial under free-living conditions.
Lee YM et al., Eur J Nutr. 2003; 42(2): 111-117.
In this randomized, placebo-controlled, double-blind clinical trial the effect of a phytosterol-enriched spread in 85 subjects with Type 2 diabetes mellitus on serum lipids was investigated in two parallel groups over 12 weeks. The participants consumed 20 g of spread with or without 1.6 g plant sterol esters daily. Total cholesterol concentrations and LDL-cholesterol concentrations were significantly reduced by 5.2% and 6.8% respectively compared to baseline after 4 weeks. After 8 and 12 weeks the reductions became smaller, but there was still a significant difference between the control and plant sterol groups. This clinical study shows that phytosterol-enriched spread is effective in lowering total and LDL-cholesterol in subjects with Type 2 diabetes. Although the effect is modest, it may contribute to decreasing the elevated risk of cardiovascular disease in Type 2 diabetes.

Plant sterols lower LDL-cholesterol without improving endothelial function in prepubertal children with familial hypercholesterolaemia.
Jongh de S et al., J Inherit. Metab Dis. 2003; 26: 343-351
In a double-blind crossover trial, the effect of plant sterol enriched spread on plasma cholesterol and vascular function in 41 pre-pubertal children with familial hypercholesterolaemia was evaluated. Over a 4 week period children consumed 15g of plant sterol-enriched spread (2.3 g plant sterols/day) and a placebo spread. Total cholesterol concentrations decreased by 11% and LDL-cholesterol concentrations by 14% as compared to placebo spread. The present study shows a clear reduction of LDL-cholesterol by plant sterol enriched spread in children with familial hypercholesterolemia. However, short term plant sterol treatment did not improve the endothelial function in these children with familial hypercholesterolaemia.

Efficacy and safety of plant stanols and sterols in the management of blood cholesterol levels.
Katan MB et al., (Stresa Workshop, Italy 2001) Mayo Clin Proc. 2003; 78: 965-978.
This review summarizes the deliberations of 32 experts on lipids, nutrition and heart disease to discuss the efficacy and safety of sterols and stanols. A meta-analysis of 41 trials showed that an intake of 2 g/d of plant sterols or stanols reduced LDL-cholesterol by 10% and that the efficacy of sterols and stanols is similar. When sterols and stanols are combined with diets low in saturated fat and cholesterol reductions in LDL-cholesterol of 20% or more can be achieved. When diet and drug interventions are combined there is an additive effect. The safety of plant sterols and stanols was also discussed in the workshop. In conclusion, current evidence is sufficient to promote use of sterols and stanols for lowering LDL-cholesterol levels in people with elevated cholesterol levels at increased risk of coronary heart disease.

Long-term compliance and changes in plasma lipids, plant sterols and carotenoids in children and parents with FH consuming plant sterol ester-enriched spread.
Amundsen A et al., Eur J Clin Nutr. 2004; 58(12):1612-20.
In a 26-week open-label follow-up of children with familial hypercholesterolemia (FH) (who had previously been studied in a controlled cross-over study design), compliance and changes in plasma lipids were studied in 37 children and 20 of their parents. Subjects were recommended to eat 20g/day of plant sterol ester-enriched spread (1.8 g plant sterols/day) as part of their lipid lowering diet. Nineteen of the parents, but no children, used statins. The mean intake of plant sterol enriched spread was 13.7 and 16.5 g/day in the children and parents respectively, corresponding to 1.2 g and 1.5 g/day of plant sterols. Plasma total cholesterol was significantly decreased by 9.1% in both children and parents. The corresponding decreases in LDL-cholesterol were 11.4% and 11.0% respectively. In this study, sustained cholesterol lowering efficacy and long-term compliance to plant sterol ester enriched spread intake was demonstrated in a free-living, less controlled setting.

Increased intake of fruit and vegetables and a low-fat diet, with and without low-fat plant sterol-enriched spread consumption: effects on plasma lipoprotein and carotenoid metabolism
Colgan HA et al., J Hum Nutr Dietet 2004; 17: 561-569.
This randomised, cross-over double blind study determined the effect of specific dietary advise to increase daily fruit and vegetable intake on plasma carotenoid concentrations while following a low fat National Cholesterol Education Programme (NCEP) Step 1 diet, including plant sterol ester enriched spread intake. Forty-eight hypercholesterolemic men consumed 21 g/day of a low fat plant sterol ester-enriched spread (1.3 g plant sterols/day) or placebo for 3 weeks. Plasma total and LDL-cholesterol were significantly reduced by 4.6% and 7.1% respectively. After lipid standardisation, plasma beta-carotene concentrations were not significantly lowered by plant sterol ester consumption. Hence, dietary advise to increase fruit and vegetable consumption was effective in preventing a reduction in plasma carotenoid concentrations previously associated with plant sterol ester consumption. In conclusion, plant sterol ester enriched low fat spread consumed as part of a low fat NCEP Step 1 diet is effective in reducing total and LDL-cholesterol.

Direct comparison of a dietary portfolio of cholesterol-lowering foods with a statin in hypercholesterolemic participants.
Jenkins DJ et al., Am J Clin Nutr 2005; 81(2):380-387.
In a randomised cross-over design, this study compared within the same subjects the cholesterol lowering effect of a dietary portfolio with that of a statin. Thirty-four hyperlipidemic subjects completed three (one month) treatments in random order as outpatients: a very low saturated fat diet, the same diet plus 20mg lovastatin (statin diet) and a diet high in plant sterols (1.0 g/1000 kcal) delivered in a spread, soy-protein foods, almonds and viscous fibres. LDL-cholesterol concentrations significantly decreased by 8.5%, 33.3% and 29.6% after 4 weeks of the control, statin, and portfolio diets respectively. The statin and the portfolio diets did not differ in their ability to reduce LDL-cholesterol below the 3.4mmol/L primary prevention cut-off. This study concludes that dietary combinations may not differ in potency from first-generation statins in achieving lipid goals for primary prevention.

^{(* the general term plant sterols encompasses both plant sterols and plant stanols)}

EFFICACY OF PLANT STEROL* ENRICHED DAIRY FOODS

Effects of yoghurt enriched with plant sterols on serum lipids in patients with moderate hypercholesterolemia.
Volpe R et al., Br J Nutr 2001; 86(2): 233-239.
In a randomised, double-blind, placebo controlled, cross-over investigation, 30 subjects with moderate hypercholesterolemia consumed a low-fat yoghurt drink (100ml/day) enriched with plant sterols (1g/day) for 4 weeks while consuming a low fat diet (<30% energy). Compared to baseline plant sterol enriched yoghurt consumption reduced total cholesterol by 6.7% and LDL-cholesterol by 11.1%. Compared to control yoghurt, there was a 4.4% lowering in total cholesterol and 6.2% lowering in LDL-cholesterol. No change in HDL-cholesterol or triglycerides was detected during the study. The effect of a higher dose of plant sterols (2g/day), without control group comparison, was tested in a subset of 11 subjects over 8 weeks. There was a decrease in total cholesterol by 11.2% and LDL-cholesterol by 15.6%. The authors conclude that a low-fat yoghurt drink enriched with plant sterols may lower total cholesterol and LDL-cholesterol in patients with moderate hypercholesterolemia who are unresponsive to conventional low-fat diet therapy.

Effects of plant stanol esters supplied in low-fat yoghurt on serum lipids and lipoproteins, non-cholesterol sterols and fat soluble antioxidant concentrations
Mensink RP et al., Atherosclerosis 2002; 160(1): 205-213.
In a double-blind, placebo controlled, parallel design study, 60 non-hypercholesterolemic subjects consumed low-fat yoghurt (450g/day) enriched with plant stanols (3g/day) over 3 weeks while consuming a low fat diet (30% energy). There was a significant reduction in total cholesterol and LDL-cholesterol when consuming the plant stanol enriched yoghurt but not the control group, with a between group difference of 8.7% and 13.7% respectively. There was no change in HDL-cholesterol or triglycerides during the intervention. The effect on LDL-cholesterol were maximal after 1 week of yoghurt consumption. The authors conclude that low-fat yoghurt enriched with plant stanols lowers LDL-cholesterol to the same extent as fat based products (e.g. spreads and margarine’s).  

Cholesterol-lowering effects of plant sterol esters differ in milk, yoghurt, bread and cereal
Clifton PM et al., Eur J Clin Nutr 2004; 58(3): 503-509.
In a randomised, single-blind, incomplete cross-over study, 58 subjects with mild hypercholesterolemia consumed four plant sterol ester enriched low-fat foods (bread, breakfast cereal, milk and yoghurt) for 3 weeks each. The foods delivered 1.6g/day of plant sterols. Background diet did not differ between the treatments. Total cholesterol and LDL-cholesterol were lowered significantly by plant sterol ester enriched milk consumption (9.7% and 15.9% respectively) and yoghurt consumption (5.6% and 8.6% respectively) compared to the control group. In the plant sterol enriched bread treatment LDL-cholesterol was reduced by 6.5% and in the plant sterol enriched cereal LDL-cholesterol was reduced by 5.4%. The authors conclude that the cholesterol lowering effect of plant sterol esters may differ according to the food matrix used.

Effect of free plant sterols in low-fat milk on serum lipid profile in hypercholesterolemic subjects
Thomsen AB et al., Eur J Clin Nutr 2004; 58(6): 860-870.
In a double-blind, randomised, placebo controlled, three arm cross-over study, 71 subjects with mild hypercholesterolemia consumed plant sterol enriched low-fat milk (500ml/day) for 4 weeks. The interventions were a placebo low-fat milk and low-fat milk enriched with nonesterified, nonhydrogenated plant sterols at the level of 1.2g/day and 1.6g/day. Background diet was habitual dietary intake. Total cholesterol and LDL-cholesterol were lowered significantly by the 1.2g/day plant sterol intake (4.7% and 7.1% respectively) and 1.6g/day plant sterol intake (7.1% and 9.6% respectively) compared to placebo. There was no between group (1.2g/day vs 1.6g/day plant sterol intake) difference in cholesterol reduction, hence there was no dose response effect detected. There was no change in HDL-cholesterol or triglycerides during the intervention. This study showed a significant cholesterol-lowering effect of plant sterol enriched low-fat milk.

Plant sterol ester-enriched milk and yoghurt effectively reduce serum cholesterol in modestly hypercholesterolemic subjects
Noakes M et al., Eur J Nutr published online 17-8-2004
Two studies were carried out to assess the cholesterol lowering effect of a plant sterol ester enriched low-fat milk, a plant sterol ester enriched low-fat yoghurt and a plant stanol ester enriched low-fat yoghurt in modestly hypercholesterolemic subjects. In both studies, background diet was habitual dietary intake (30% energy). The first study (n=39) was a single-blind, placebo controlled, cross-over trial with 3 week interventions. The interventions were 300ml/day of placebo or plant sterol (2 g/day) enriched low-fat milk, and 25g/day of placebo or plant sterol (2g/day) enriched spread. Total cholesterol and LDL-cholesterol were lowered significantly by the plant sterol enriched low-fat milk (5.5% and 7.9% respectively) compared to placebo group. The plant sterol enriched spread lowered total cholesterol and LDL-cholesterol by 8.0% and 10.1% respectively, which was not significantly different from the effect of plant sterol enriched low-fat milk. There was no effect on HDL-cholesterol or triglycerides during the intervention.

The second study (n=40) was a randomised, placebo controlled, double-blind, cross-over trial with 3 week interventions. Subjects consumed 300g/day of placebo low-fat yoghurt, low-fat yoghurt enriched with plant sterols (1.8g/day) and low-fat yoghurt enriched with plant stanols (1.7g/day). Total cholesterol and LDL-cholesterol were significantly reduced by the plant sterol ester enriched yoghurt (4.4% and 6.1%, respectively) and the plant stanol enriched yoghurt (3.5% and 5.2%, respectively) compared to placebo group. There was no effect on HDL-cholesterol or triglycerides.

The authors conclude that plant sterol esters when provided in low-fat milk and yoghurt are effective in lowering total and LDL-cholesterol. (* the general term plant sterols encompasses both plant sterols and plant stanols)