Long-term Effects of Plant Stanols on the Lipid Profile of Patients With Hypercholesterolemia. A Randomized Clinical Trial

Abstract

Introduction and objectives: Plant stanol consumption may improve long-term cholesterol control. The aim of the present study was to evaluate the effectiveness of 2g/day of plant stanols in reducing low-density lipoprotein cholesterol levels in patients with hypercholesterolemia.

Methods: This randomized, double-blind, and placebo-controlled study included 182 adults diagnosed with hypercholesterolemia. A yogurt drink containing 2g of plant stanols was administered to 91 participants in the intervention group; 91 participants in the control group received unsupplemented yogurt. The primary end point was the change in the lipid profile at 12 months.

Results: Low-density lipoprotein cholesterol levels at 12 months were significantly more reduced in the stanol intervention group than in the control group: 13.7 (95% confidence interval, 3.2-24.1) mg/dL (P=.011). A reduction of more than 10% in low-density lipoprotein cholesterol was achieved by a significantly higher proportion of participants in the intervention group (relative risk=1.7; 95% confidence interval, 1.1-2.7). In this group, the mean (standard deviation) level of low-density lipoprotein cholesterol decreased by 11.0% (23.9%).

Conclusions: Our results confirm that administration of plant stanols at a dosage of 2 g/day for 12 months significantly reduces (by slightly more than 10%) the concentrations of low-density lipoprotein cholesterol in individuals with hypercholesterolemia. Trial registration (www.ClinicalTrials.gov): Current Controlled Trials NCT01406106.

Keywords: Atención primaria de salud; Clinical trial; Ensayo clínico; Fitosteroles; Hipercolesterolemia; Hypercholesterolemia; Phytosterols; Primary health care.