Efficacy and tolerability of a novel herbal formulation for weight management in obese subjects: a randomized double blind placebo controlled clinical study

BACKGROUND: The effect of an herbal formulation LI85008F on weight loss in obese human subjects was evaluated in an 8-weeks randomized, double-blind, placebo-controlled study (Clinical Trial Registration no. ISRCTN37381706). Fifty obese subjects (Body mass index 30 to 40 kg/m², 29.3% male; 70.7% female; ages 27–50 years) were randomized into two groups; placebo (n = 25) and LI85008F formulation (n = 25). The participants received either 900 mg/day of LI85008F formulation in three divided doses or three identical placebo capsules and all of them remained on a calorie-controlled diet (2000 cal/day) and 30 min walking for 5 days a week during the entire duration of the study. RESULTS AND DISCUSSION: At the end of the trial period, LI85008F supplemented group showed significant net reductions in body weight and Body Mass Index (BMI). The participants who received the herbal formulation, showed reduced fasting blood glucose, LDL, LDL/HDL ratio, and triglycerides. At the end of the study, LI85008F supplementation also provided 21.26% (p = 0.012) increase in serum adiponectin level, compared with the placebo group. No major adverse events were reported by the participants in the study duration. In addition, Adipokine profiling study in 3T3-L1 adipocytes demonstrates that LI85008F modulates key regulatory factors of adipogenic differentiation and insulin sensitivity, such as Adiponectin, Pref-1, and resistin. CONCLUSION: The herbal formulation LI85008F (Adipromin) is prepared from commonly used medicinal plants extracts, which provides useful and safe application for weight loss in obese humans. It also demonstrates potential promise in controlling healthy blood glucose level in obesity linked type 2 diabetes.