Lipid effects of a dietary supplement softgel capsule containing plant sterols/stanols in primary hypercholesterolemia

• Published in: Nutrition (Burbank, Los Angeles County, Calif.) Vol. 29; no. 1; pp. 96 - 100
• Main Authors: Maki, Kevin C., Lawless, Andrea L., Reeves, Matthew S., Kelley, Kathleen M., Dicklin, Mary R., Jenks, Belinda H., Shneyvas, Ed, Brooks, James R.
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.01.2013; Elsevier; Elsevier Limited
• Subjects: administration & dosage; Biological and medical sciences; blood; body mass index; Capsules; Cardiovascular disease; Cholesterol; Cholesterol - blood; Cholesterol, HDL; Cholesterol, HDL - blood; Cholesterol, LDL; Cholesterol, LDL - blood; Cross-Over Studies; Diet; dietary fat; Dietary Supplements; Disorders of blood lipids. Hyperlipoproteinemia; drug therapy; education programs; Feeding. Feeding behavior; Female; Fundamental and applied biological sciences. Psychology; Gastroenterology and Hepatology; Gels; Humans; Hypercholesterolemia; Hypercholesterolemia - blood; Hypercholesterolemia - drug therapy; lifestyle; lipid content; Lipids; Lipids - blood; Low density lipoprotein; Low-density lipoprotein cholesterol; Male; Medical sciences; Metabolic diseases; Middle Aged; Non–high-density lipoprotein cholesterol; Phytosterols; Phytosterols - administration & dosage; Phytotherapy; placebos; Plant stanols; Plant sterols; Single-Blind Method; triacylglycerols; Triglycerides; Triglycerides - blood; Vertebrates: anatomy and physiology, studies on body, several organs or systems; women; Hypercholesterolemia; Plant sterols; Phytosterols; Dietary supplements; Plant stanols; Non–high-density lipoprotein cholesterol; Low-density lipoprotein cholesterol; Metabolic diseases; Lipids; Hyperlipoproteinemia; Cholesterol; Lipoprotein LDL; Plant; Phytosterol; Dyslipemia; Lipoprotein HDL; Non-high-density lipoprotein cholesterol; Sterol
• ISSN: 0899-9007; 1873-1244; 1873-1244
• DOI: 10.1016/j.nut.2012.05.002

This randomized, placebo-controlled, crossover trial assessed the lipid-altering efficacy of a softgel capsule dietary supplement, providing esterified plant sterols/stanols 1.8 g/d, in 28 participants (∼75% women) with primary hypercholesterolemia (fasting low-density lipoprotein cholesterol [LDL-C] levels ≥130 and <220 mg/dL), a mean age of 58.4 y, and a mean body mass index of 27.9 kg/m2. After a 5-wk National Cholesterol Education Program (NCEP) Therapeutic Lifestyle Changes (TLC) diet and a single-blinded placebo lead-in, subjects received double-blinded placebo or sterol/stanol softgel capsules for 6 wk and then crossed over to the opposite product for 6 wk while continuing the TLC diet. Fasting lipids were assessed in duplicate at the end of the diet lead-in (baseline) and the end of each treatment. The mean baseline lipid concentrations (milligrams per deciliter) were 223 for total cholesterol (TC), 179 for non–high-density lipoprotein cholesterol (non-HDL-C), 154 for low-density lipoprotein cholesterol, 44 for HDL-C, 125 for triacylglycerols, and 5.2 for TC/HDL-C. Differences from the control responses (plant sterol/stanol minus control) in the per-protocol sample were significant (P < 0.05) for LDL-C (−9.2%), non-HDL-C (−9.0%), TC (−7.4%), TC/HDL-C (−5.4%), and triacylglycerols (−9.1%). The HDL-C responses were not significantly different between treatments. The incorporation of softgel capsules providing esterified plant sterols/stanols 1.8 g/d into the NCEP TLC diet produced favorable changes in atherogenic lipoprotein cholesterol levels in these subjects with hypercholesterolemia.