A 12-Week Randomized,Double-Blind,Placebo-Controlled Trial of Salacia reticulata Extract for Fat-Mass Reduction in Adults with Overweight/Obesity

Abstract

Salacia reticulata has long been used in traditional medicine for metabolic disorders, but clinical evidence for obesity-related outcomes remains limited. We conducted a 12-week randomized, double-blind, placebo-controlled trial to evaluate the preliminary efficacy and safety of a standardized Salacia reticulata extract (SLE) on body-fat outcomes. Adults with overweight and/or obesity were randomized to receive SLE capsules or a matching placebo twice daily for 12 weeks. The coprimary endpoints were changes from baseline to week 12 in total body fat mass (g) and body fat percentage (%) measured by dual-energy X-ray absorptiometry. The primary efficacy analysis was conducted in the full analysis set (mITT) using analysis of covariance with baseline values and sex as covariates. Per-protocol set analyses were performed as supportive sensitivity analyses. Among randomized participants, the mITT included 66 participants in the SLE group and 67 in the placebo group, and baseline characteristics were comparable. After 12 weeks, total body fat mass decreased in the SLE group, whereas little change was observed in the placebo group. The between-group difference favored SLE (ANCOVA-adjusted LS mean difference, −482.30 g; 95% CI, −907.05 to −57.54 g). The corresponding between-group comparison was statistically significant (Wilcoxon rank-sum test, P = .0158). Body fat percentage also decreased in the SLE group, but the between-group difference was not statistically significant (ANCOVA-adjusted LS mean difference, −0.30%; 95% CI, −0.73 to 0.12%; Wilcoxon rank-sum test, P = .1453). Several secondary body-composition outcomes, including trunk, android and gynoid fat measures, showed directionally favorable changes in the SLE group. In this 12-week trial, SLE was associated with a modest reduction in total body fat mass, whereas the second coprimary endpoint, body fat percentage, did not differ significantly between groups. These mixed coprimary findings provide only preliminary clinical evidence and should be interpreted with caution, particularly given the study’s retrospective trial registration.