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Clinical studies have demonstrated that supplemental phytosterols can lower total cholesterol an average of 6 - 10%, and LDL-cholesterol 8 - 15%. Additionally, studies show that use of supplemental phytosterols in combination with statins may provide additional reductions in blood cholesterol. For example, the combination of statins and phytosterols lowered blood cholesterol by 39%, with sterols contributing 7% of the overall reduction. Importantly, phytosterols do not appear to cause a statistically significant decrease in HDL cholesterol.
A brief overview of a number of the phytosterol studies is given below:
- In a randomized, controlled, single-blind study, 22 hypercholesterolaemic subjects were given a phytosterol enriched breakfast cereal, breads and margarine-like spreads to consume on a daily basis. After 12 weeks, subjects experienced a 13.6% reduction in median LDL cholesterol from the consumption of 2.4 g of sterol esters/day.
- A study in healthy volunteers evaluated the safety and efficacy of phytosterol-enriched spreads. This 12 month randomized, double-blind placebo-controlled study found that consumption of 1.6 g/day of phytosterols lowered total and LDL-cholesterol by 4 and 6%, respectively, and demonstrated that consumption of these phytosterols is both efficacious and safe for long term use.
- A study involving 38 children between the ages of 7 and 12 years with familial hypercholesterolemia consumed either a margarine type spread (placebo) or phytosterol-containing spread with 1.6 g of phytosterols for 8 weeks. Reductions in total cholesterol of 7.4% and LDL-cholesterol levels by 10.2% were observed. Triglycerides and HDL were unaffected in this study.
The safety of phytosterols has also been confirmed by their achieving GRAS (Generally Recognized as Safe) status in the late 1990s. In 2000 the FDA approved the use of cardiovascular disease reduction claims for certain foods that contain plant sterols and stanols. Recently, the FDA has acknowledged extensions of these health claims to include a wider variety of foods including dietary supplements. The result has been an increase in the number of dietary supplements that now contain phytosterols.
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