Reduction of serum cholesterol with sitostanol-ester margarine in a mildly hypercholesterolemic population

• Published in: The New England journal of medicine Vol. 333; no. 20; pp. 1308 - 1312
• Main Authors: Miettinen, T.A. (University of Helsinki, Helsinki, Finland.), Puska, P, Gylling, H, Vanhanen, H, Vartiainen, E
• Format: Journal Article
• Language: English
• Published: Boston, MA Massachusetts Medical Society 16.11.1995
• Subjects: ACIDE GRAS; ACIDE GRAS POLYINSATURE; ACIDE GRAS SATURE; ACIDOS GRASOS; ACIDOS GRASOS POLIINSATURADOS; ACIDOS GRASOS SATURADOS; administration & dosage; Adult; ADULTE; ADULTOS; adults; analogs & derivatives; Anticholesteremic Agents; Anticholesteremic Agents - administration & dosage; Anticholesteremic Agents - therapeutic use; Biological and medical sciences; blood; blood lipids; blood serum; campesterol; CHOLESTEROL; Cholesterol - analogs & derivatives; Cholesterol - blood; Cholesterol, HDL; Cholesterol, HDL - blood; Cholesterol, LDL; Cholesterol, LDL - blood; COLESTEROL; CORPS GRAS; DIETA; dietary fat; Dietary Fats; Dietary Fats - administration & dosage; Disorders of blood lipids. Hyperlipoproteinemia; dose response; Double-Blind Method; drug therapy; ESTER; ESTERES; ESTEROLES; Fatty acids; Female; Finland; FINLANDE; FINLANDIA; FITOSTEROLES; GRASAS; HEMOLIPIDOS; high density lipoprotein; HIPERLIPIDEMIA; Humans; hypercholesterolemia; Hypercholesterolemia - blood; Hypercholesterolemia - drug therapy; HYPERLIPIDEMIE; INGESTION DE NUTRIENTES; INGESTION DE SUBSTANCES NUTRITIVES; LIPIDE SANGUIN; LIPOPROTEINAS; LIPOPROTEINE; longitudinal studies; low density lipoprotein; Male; MARGARINA; MARGARINE; Medical sciences; Metabolic diseases; Middle Aged; monounsaturated fatty acids; nutrient intake; PHYTOSTEROL; Phytosterols; polyunsaturated fatty acids; REGIME ALIMENTAIRE; saturated fatty acids; SERUM SANGUIN; Sitosterols; Sitosterols - administration & dosage; Sitosterols - therapeutic use; STEROL; sterol esters; Sterols; SUERO SANGUINEO; therapeutic use; Trans fats; triacylglycerols; TRIGLICERIDOS; TRIGLYCERIDE; Triglycerides; Triglycerides - blood; Finland; Human; Hypercholesterolemia; Treatment; Metabolic diseases; Lipids; Serum; Hyperlipoproteinemia; Margarine; Statistical study; Cholesterol; Feeding; Quantitative analysis
• ISSN: 0028-4793; 1533-4406
• DOI: 10.1056/NEJM199511163332002

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 tolerability and cholesterol-lowering effect of margarine containing sitostanol ester in a population with mild hypercholesterolemia. Methods. We conducted a one-year, randomized, double-blind study in 153 randomly selected subjects with mild hypercholesterolemia. Fifty-one consumed margarine without sitostanol ester (the control group), and 102 consumed margarine containing sitostanol ester (1.8 or 2.6 g of sitostanol per day). Results. The margarine containing sitostanol ester was well 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 cholesterol concentration between the two groups was -24 mg per deciliter (95 percent confidence interval, -17 to -32; P0.001). The respective reductions in low-density lipoprotein (LDL) cholesterol were 14.1 percent in the sitostanol group and 1.1 percent in the control group. The difference in the change in LDL cholesterol concentration between the two groups was -21 mg per deciliter (95 percent confidence interval, -14 to -29; P0.001). Neither serum triglyceride nor high-density lipoprotein 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 the reduction was directly correlated with the reduction in total cholesterol (r