Cholesterol-lowering effect of stanol ester in a US population of mildly hypercholesterolemic men and women: A randomized controlled trial

Objective: To determine the efficacy of stanol esters in lowering cholester ol in a US population. Subjects and Methods: After a run-in phase, 318 subjects were randomized to receive one of the following margarine-like spreads containing stanol este r or placebo for 8 weeks: EU 3 G: 1 g of stanol (ester form) per 8-g servin g of a European formula 3 times a day; US 3 G: 1 g of stanol (ester form) p er 8-g serving of a US reformulation 3 times a day; US 2 G: 0.67 g of stano l (ester form) per 8-g serving of a US reformulation 3 times a day; or plac ebo spread, Results: Mean +/- SD baseline total cholesterol (TC) and low-density lipopr otein cholesterol (LDL-C) levels were 233+/-20 and 153+/-21 mg/dL, respecti vely. In the US 3 G group, 3 g daily of stanol esters lowered TC and LDL-C levels by 6.4% and 10.1%, respectively. There was a dose-dependent response compared with 2 g daily (US 2 G), Triglyceride and high-density lipoprotei n cholesterol levels were unchanged. The incidence of adverse effects was n ot different from placebo, Serum vitamin A and 25-hydroxyvitamin D levels w ere not affected, Conclusions: Stanol esters lowered TC and LDL-C levels in a mildly hypercho lesterolemic US population without evidence of adverse effects. It may be a useful dietary adjunct to lower cholesterol.