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

BACKGROUND: Although plant (PS) lower LDL-cholesterol in normal-weight individuals, their efficacy in obesity is unclear. OBJECTIVE: To evaluate the effect of PS supplementation on LDL-cholesterol (primary outcome) and on body composition, other biochemical, lifestyle, and sarcopenia parameters (secondary, exploratory outcomes) in individuals with overweight or class I-III obesity and mild hypercholesterolemia. METHODS: A randomized, double-blind, placebo-controlled crossover clinical trial was conducted in 23 participants (BMI: 36.4 ± 4.2 kg/m²). Participants consumed a food supplement with 2 g/day of PS or a placebo for 8 weeks per phase, with a 6-week 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% CI -7.1, 7.3] after PS vs. +3.9 mg/dL [-7.6, 15.4] after placebo. No difference was found between PS and placebo in any other lipid parameter, in hs-CRP, 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. CONCLUSION: In individuals with overweight or class I-III obesity, 2 g/day 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-C and therefore, the secondary findings are exploratory and require confirmation in adequately powered trials. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT06481020 URL OF REGISTRATION: https://clinicaltrials.gov/study/NCT06481020.