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

Abstract

BackgroundThe 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 discussionAt 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.ConclusionThe 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.

Efficacy of a novel herbal formulation for weight loss demonstrated in a 16‐week randomized, double‐blind, placebo‐controlled clinical trial with healthy overweight adults

“…Group size estimations were based on power calculations, predicting the effect size and variations between and within groups. The effect and deviation sizes observed in the previous clinical study conducted in obese participants were 1.79 and 1.52 in the placebo, and 4.76 and 2.3 in the LI85008F groups, respectively. As the current study was conducted in healthy overweight participants, a lower effect size was considered.…”

“…Supplementation of LI85008F in obese adults in an 8‐week double‐blind placebo‐controlled clinical study resulted in significant reductions in body weight and BMI along with improvements in serum lipid profiles and a significant increase in serum adiponectin. Observations relevant to safety parameters supported that LI85008F was well tolerated and safe . A comprehensive set of in vitro and in vivo toxicological studies also support the safety of LI85008F…”

“…In addition, biochemical, haematological parameters and subject compliance show that LI85008F is tolerable and safe for human consumption. Previously, LI85008F was shown to be a clinically effective and safe herbal composition for body weight management in obese participants …”

“…(family Rutaceae) leaf aqueous ethanol extract, and 1 part Curcuma longa L. ( family Zingiberaceae) extract standardized to not less than 95% total curcuminoids. Identification, collection of the plant raw materials, and the extraction procedures of the individual ingredients from the respective raw materials were described previously . The finished formulation was standardized to contain at least 7.0% total curcuminoids, 0.1% Mahanine and 0.2% Quercetin 3‐O‐glycoside.…”

“…Participants visiting the outpatient departments of the clinics were selected for screening. After voluntarily signing informed consent, male and female participants were screened for eligibility for enrollment into the study based on the inclusion and exclusion criteria, as previously described but with some modifications. Briefly, criteria for eligibility required that participants be aged 21‐50 years, have a BMI 27‐29.9 kg/m 2 , have an apparently healthy status based on their medical history, be free from metabolic bone disease, gastrointestinal disease, diabetes mellitus (type 1 or 2), cardiovascular disease, renal disease and abnormal liver function, on no medications or vitamin supplements, and not pregnant or lactating.…”