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

Lipids in Health and Disease

Golakoti Trimurtulu⁴  Alluri V Krishnaraju⁴  Kadainti VS Sarma¹  Manikeshwar K Rao³  Atmatrana T Mishra²  Krishanu Sengupta⁴ 

[1]Department of Statistics, SV University, Tirupati, India

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

[3]Suraksha Health Village, Gurunanak Nagar, Vijayawada, India

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

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

Others  :  1160110
DOI  :  10.1186/1476-511X-11-176

 received in 2012-11-03, accepted in 2012-12-12,  发布年份 2012

【 摘 要 】

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.

【 授权许可】

   
2012 Sengupta et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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