Serum cholesterol-lowering efficacy of stanol ester incorporated in gelatin capsules

Abstract

Background: The cholesterol-lowering properties of plant sterols have been known since the 1950s. In most clinical studies the efficacy of plant stanol ester has been studied when incorporated into mayonnaise, regular or low-fat spreads or yoghurt. Objective: The purpose of this study was to confirm the cholesterol-lowering efficacy of plant stanol ester when incorporated in capsules as part of a normal everyday diet. Design: The study had a randomized double-blind parallel design with an intervention period of 3 weeks. Forty-two subjects were randomized to receive either the active capsule (2 g of stanol) or the placebo capsule. Results: Stanol ester capsules effectively decreased the low-density lipoprotein (LDL)-cholesterol level by 8.5% [95% confidence interval (CI) 4.1 to 13.0%, p<0.001 vs baseline, p<0.05 vs placebo]. Total cholesterol concentration was reduced by 4.6% (95% CI 1.3 to 8.0%, p<0.01) and the apolipoprotein B level by 6.5% (95% CI 2.0 t o 11.0%, p<0.01) versus baseline. The LDL/HDL ratio was reduced by 10.6% (95% CI 5.2 to 16.0%, p<0.001) versus baseline. Conclusions: Plant stanol ester reduces LDL-cholesterol effectively, even when provided in a fat-free matrix such as capsules. Keywords: adult; cholesterol lowering; gelatin capsule; intervention; serum cholesterol; stanol ester