Objective: The objective of this work was to show that fat-free, lecithin-formulated soy stanols lower cholesterol absorption and serum LDL cholesterol.
Design: Reduction in cholesterol absorption was measured in paired single-meal tests with or without formulated soy stanols (acute test), and changes in serum lipids were investigated in a 10-week, randomized, double-blind parallel trial in which formulated stanols or lecithin vehicle were given three times daily for the last 4 weeks (chronic test).
Subjects/setting: Forty-five normal or mildly hypercholesterolemic subjects were recruited for both studies. The 21 subjects (16 female, 5 male; mean age 32.5 years) in the absorption studies had the following mean lipid values: LDL cholesterol, 2.79 mmol/L and total cholesterol, 4.73 mmol/L. For the lipid reduction, 24 subjects (16 female, 8 male; mean age 50.6 years) were enrolled with mean LDL cholesterol and total cholesterol of 3.72 mmol/L and 5.66 mmol/L, respectively.
Intervention: Reduction in cholesterol absorption was measured using a lemonade beverage or egg whites that contained 625 mg stanols. Throughout the chronic study, subjects followed the American Heart Association Step I diet. During the 4-week treatment phase, subjects consumed daily a lemonade-flavored beverage containing either placebo or formulated soy stanols (1.9 g).
Main outcome measures: Inhibition of cholesterol absorption was determined from the difference in plasma deuterated cholesterol enrichment after a test meal containing stanol-lecithin and one with lecithin vehicle only. In the chronic study, the primary endpoints were changes in LDL and total cholesterol.
Statistical analyses performed: Paired or unpaired t tests were used to determine statistical significance.
Results: Stanol-lecithin reduced cholesterol absorption by 32.1% (P=.0045, n=10) and by 38.2% (P=.0022, n=11) when delivered in a lemonade-flavored beverage and in egg whites, respectively. Reduction in cholesterol absorption was strongly related to the initial level of absorbed cholesterol tracer in serum (r(s)=-0.739). Stanol-lecithin given in a beverage reduced total serum cholesterol by 10.1% (P=.0019, n=24) and LDL cholesterol by 14.3% (P=.0016, n=24).
Applications/conclusions: Powdered soy stanol-lecithin lowers cholesterol absorption and LDL cholesterol when consumed in fat-free foods.