Salacia reticulata has been utilized in traditional medicine for its potential benefits in managing metabolic disorders. However, clinical evidence supporting its efficacy in obesity-related outcomes has been limited. This study aimed to evaluate the preliminary efficacy and safety of a standardized extract of Salacia reticulata (SLE) on body fat outcomes in adults with overweight or obesity.
The study was designed as a 12-week randomized, double-blind, placebo-controlled trial. Participants were randomly assigned to receive either SLE capsules or a matching placebo, administered twice daily. The primary endpoints included changes in total body fat mass (measured in grams) and body fat percentage (measured in percentage) from baseline to week 12, assessed using dual-energy X-ray absorptiometry.
A total of 133 participants were included in the full analysis set (mITT), with 66 in the SLE group and 67 in the placebo group. The baseline characteristics of the participants were comparable across both groups. After 12 weeks, the results indicated a decrease in total body fat mass in the SLE group, while the placebo group showed little change. The between-group difference was statistically significant, with an ANCOVA-adjusted least squares mean difference of -482.30 g (95% CI, -907.05 to -57.54 g; P = .0158).
In terms of body fat percentage, the SLE group also experienced a decrease; however, this difference was not statistically significant, with an ANCOVA-adjusted least squares mean difference of -0.30% (95% CI, -0.73 to 0.12%; P = .1453). Additionally, several secondary body composition outcomes, including trunk, android, and gynoid fat measures, showed directionally favorable changes in the SLE group.
Despite the modest reduction in total body fat mass associated with SLE, the mixed findings regarding body fat percentage highlight the need for cautious interpretation of these results. The study’s retrospective trial registration further emphasizes the preliminary nature of the clinical evidence provided.
What this study does not show
This study does not establish long-term efficacy or safety of Salacia reticulata extract beyond the 12-week trial period.
Evidence scorecard
- Analytic validity: Established
- Clinical validity: Established
- Clinical utility: Partial
The evidence is based on a randomized controlled trial involving human participants.