REDUCTION OF SERUM-CHOLESTEROL WITH SITOSTANOL-ESTER MARGARINE IN A MILDLY HYPERCHOLESTEROLEMIC POPULATION

Background. Dietary plant sterols, especially sitostanol, reduce serum cholesterol by inhibiting cholesterol absorption. Soluble sitostanol may be more effective than a less soluble preparation. We tested the t olerability and cholesterol-lowering effect of margarine containing si tostanol ester in a population with mild hypercholesterolemia. Methods . We conducted a one-year, randomized, double-blind study in 153 rando mly selected subjects with mild hypercholesterolemia. Fifty-one consum ed margarine without sitostanol ester (the control group), and 102 con sumed margarine containing sitostanol ester (1.8 or 2.6 g of sitostano l per day). Results. The margarine containing sitostanol ester was wel l tolerated. The mean one-year reduction in serum cholesterol was 10.2 percent in the sitostanol group, as compared with an increase of 0.1 percent in the control group. The difference in the change in serum ch olesterol concentration between the two groups was -24 mg per decilite r (95 percent confidence interval, -17 to -32; P<0.001). The respectiv e reductions in low-density lipoprotein (LDL) cholesterol were 14.1 pe rcent in the sitostanol group and 1.1 percent in the control group. Th e difference in the change in LDL cholesterol concentration between th e two groups was -21 mg per deciliter (95 percent confidence interval, -14 to -29; P<0.001). Neither serum triglyceride nor high-density lip oprotein cholesterol concentrations were affected by sitostanol. Serum campesterol, a dietary plant sterol whose levels reflect cholesterol absorption, was decreased by 36 percent in the sitostanol group, and t he reduction was directly correlated with the reduction in total chole sterol (r=0.57, P<0.001). Conclusions, Substituting sitostanol-ester m argarine for part of the daily fat intake in subjects with mild hyperc holesterolemia was effective in lowering serum total cholesterol and L DL cholesterol.