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Open Access Highly Accessed Research

Efficacy of an herbal formulation LI10903F containing Dolichos biflorus and Piper betle extracts on weight management

Krishanu Sengupta1*, Atmatrana T Mishra2, Manikeshwar K Rao3, Kadainti VS Sarma4, Alluri V Krishnaraju1 and Golakoti Trimurtulu1

Author Affiliations

1 Laila Impex R&D Center, Unit-I, Phase-III, J. Autonagar, Vijayawada, India

2 Department of Internal Medicine, ASR Academy of Medical Sciences, Eluru, India

3 Suraksha Health Village, Gurunanak Nagar, Vijayawada, India

4 Department of Statistics, SV University, Tirupati, India

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Lipids in Health and Disease 2012, 11:176  doi:10.1186/1476-511X-11-176

Published: 27 December 2012

Abstract

Background

A novel herbal formulation LI10903F, alternatively known as LOWAT was developed based on its ability to inhibit adipogenesis and lipogenesis in 3T3-L1 adipocytes model. The clinical efficacy and tolerability of LI10903F were evaluated in an eight-week, randomized, double-blind, placebo-controlled, clinical trial in 50 human subjects with body mass index (BMI) between 30 and 40 kg/m2 (clinical trial registration number: ISRCTN37381706). Participants were randomly assigned to either a placebo or LI10903F group. Subjects in the LI10903F group received 300 mg of herbal formulation thrice daily, while subjects in the placebo group received 300 mg of placebo capsules thrice daily. All subjects were provided a standard diet (2,000 kcal daily) and participated in a moderate exercise of 30 min walk for five days a week. Additionally, the safety of this herbal formulation was evaluated by a series of acute, sub-acute toxicity and genotoxicity studies in animals and cellular models.

Results

After eight weeks of supplementation, statistically significant net reductions in body weight (2.49 kg; p=0.00005) and BMI (0.96 kg/m2; p=0.00004) were observed in the LI10903F group versus placebo group. Additionally, significant increase in serum adiponectin concentration (p=0.0076) and significant decrease in serum ghrelin concentration (p=0.0066) were found in LI10903F group compared to placebo group. Adverse events were mild and were equally distributed between the two groups. Interestingly, LI10903F showed broad spectrum safety in a series of acute, sub-acute toxicity and genotoxicity studies.

Conclusions

Results from the current research suggest that LI10903F or LOWAT is well-tolerated, safe and effective for weight management.

Keywords:
Adiponectin; Dolichos biflorus; Ghrelin; Human clinical study; LOWAT; Piper betle; Weight loss