Efficacy of 12 weeks supplementation of a botanical extract-based weight loss formula on body weight, body composition and blood chemistry in healthy, overweight subjects--a randomised double-blind placebo-controlled clinical trial.

OBJECTIVE The aim of this study was to evaluate the efficacy and safety of composite extracts in reducing weight, as the main outcome measure. Secondary measures of the study were body composition change. DESIGN Randomised, double blind, placebo-controlled clinical trial. SETTING Tertiary university clinic. SUBJECTS hundred and five subjects, 5 of them withdrawn consent, 2 drop-outs not related to study preparation. INTERVENTION two tablet per meal concept supposed to generate a "psychological" therapy-like approach during 12 weeks supported by measured physical activity. The tablets 1 (one hour before meals, comprises extracts of Asparagus, Green tea, Black tea, Guarana, Mate and Kidney beans) and 2 (taken half an hour after meals, comprises extracts of Kidney bean pods, Garcinia cambogia, and Chromium yeast) are taken twice daily with two main meals. RESULTS A significant change of the Body Composition Improvement Index (BCI) was observed in the active extract group compared to placebo (p = 0.012). Weight, BMI, waist-to-hip ratio was not statistically different between groups. Body fat loss was greater in active group (p = 0.011) compared to placebo. A weight loss parameter corrected for exercise was introduced and found to be higher in active group (p = 0.046) than in placebo, meaning that the formula was more efficacious, due to a concurrently performed exercise program--a recommended strategy for life style modification. CONCLUSIONS A significant change of the Body Composition Improvement Index and the decrease in body fat was statistically significant in active extract subjects compared to placebo. A change in some outcome measures like: weight, BMI failed to produce significant difference between groups.