Dietary supplementation with plant sterols for obesity management and related metabolic disorders: a randomized, double-blind, placebo-controlled crossover clinical trial

BACKGROUND: Although plant sterols (PS) lower low-density lipoprotein cholesterol (LDL cholesterol) in normal-weight individuals; their efficacy in obesity is unclear. OBJECTIVES: This study aimed to evaluate the effect of PS supplementation on LDL cholesterol (primary outcome) and on body composition, other biochemical, lifestyle, and sarcopenia parameters (secondary and exploratory outcomes) in individuals with overweight or class I to III obesity and mild hypercholesterolemia. METHODS: ). Participants consumed a food supplement with 2 g/d of PS or a placebo for 8 wk per phase, with a 6-wk washout period. RESULTS: LDL cholesterol did not differ between PS and placebo (P = 0.632): the change from baseline was +0.1 mg/dL [95% confidence interval (CI): -7.1, 7.3 mg/dL] after PS compared with +3.9 mg/dL (95% CI: -7.6, 15.4 mg/dL) after placebo. No difference was found between PS and placebo in any other lipid parameter, in high-sensitivity C-reactive protein, or in the glucose regulation parameters, and no between-treatment difference in body composition, sarcopenia, or lifestyle parameters remained significant after correction for multiple testing. CONCLUSIONS: In individuals with overweight or class I to III obesity, 2 g/d of PS did not reduce LDL cholesterol compared with placebo, and no effect was found on any other cardiometabolic parameter. This may reflect reduced PS efficacy in this population. The trial was powered only for LDL cholesterol. Therefore, the secondary findings are exploratory and require confirmation in adequately powered trials. This trial was registered at clinicaltrials.gov as NCT06481020.