Abstract / Summary
Background/Objectives: Plant-derived ingredients have attracted interest as adjuncts for reducing body fat, but clinical evidence for Lythrum salicaria extract alone remains limited. We evaluated its effects on body fat and its safety in adults with a body mass index (BMI) of 23–30 kg/m2. Methods: Ninety adults aged 19–75 years participated in a single-center, randomized, double-blind, placebo-controlled trial. Participants received either 500 mg/day of L. salicaria extract powder (corresponding to approximately 400 mg/day of plant-derived extract solids) or placebo for 12 weeks. The primary endpoint was the change in body fat mass from baseline to day 84, assessed by dual-energy X-ray absorptiometry (DXA). Efficacy was evaluated primarily in the per-protocol (PP) population, with supporting intention-to-treat (ITT) analyses. Anthropometric measures, other DXA outcomes, and blood markers were assessed as secondary endpoints. Results: The PP population included 84 participants. Baseline-adjusted differences in body fat mass change, expressed as extract minus placebo, were −2.01 kg (95% confidence interval [CI], −2.51 to −1.52; p < 0.001) in the PP population and −2.04 kg (95% CI, −2.66 to −1.42; p < 0.001) in the ITT population. Exploratory secondary analyses favored the extract for BMI, body weight, body fat percentage, and adiponectin. No serious adverse events occurred. Conclusions: Supplementation with L. salicaria extract powder for 12 weeks was associated with a reduction in DXA-measured body fat mass compared with placebo. Larger trials with longer follow-up are needed to confirm the findings and investigate the mechanisms involved.