Drug Design, Development and Therapy (Oct 2022)
Aframomum melegueta Seed Extract with Standardized Content of 6-Paradol Reduces Visceral Fat and Enhances Energy Expenditure in Overweight Adults – A Randomized Double-Blind, Placebo-Controlled Clinical Study
Abstract
Heggar Venkataramana Sudeep,1 Khanna Aman,2 Thomas V Jestin,3 Kodimule Shyamprasad1 1Department of Biomedicinal Research (R&D), Vidya Herbs Pvt Ltd, Bangalore, Karnataka, 560 105, India; 2Aman Hospital and Research Center, Vadodara, Gujarat, 390021, India; 3Leads Clinical Research and Bio Services Private Ltd, Bangalore, IndiaCorrespondence: Heggar Venkataramana Sudeep, Research Scientist, R&D Center for Excellence, Vidya Herbs Pvt Ltd, No. 14/A, KIADB, Jigani Industrial Area, Anekal Taluk, Bangalore, Karnataka, 560 105, India, Tel +91 80-42094158, Email [email protected]; [email protected]: Aframomum melegueta (grains of paradise) seeds have been demonstrated to possess thermogenic potential. However, it is necessary to validate the functional attributes of A. melegueta seed extract in human subjects.Methods: In a double-blind, placebo-controlled clinical trial design, we have examined the thermogenic effects of a standardized A. melegueta seed extract (AfperFit). A total of 70 overweight male and female subjects (BMI ≥ 25.0 to ≤ 30.0 kg/m2) aged 20– 50 years were enrolled and administered with either 250 mg of AfperFit or placebo in capsule form twice daily for 12 weeks. The primary efficacy endpoints included energy expenditure (indirect calorimetry), body composition (dual-energy X-ray absorptiometry (DEXA)) and fat distribution (computed tomography (CT scan)), analyzed at baseline and after 12 weeks of treatment. The effect of intervention on the quality of life was examined using SF-12 questionnaire.Results: Consumption of AfperFit significantly increased the energy expenditure (p< 0.01), visceral fat area (p< 0.001) and visceral to subcutaneous fat ratio (p< 0.01) compared to placebo group. Consequently, there was significant body weight loss and reduction in BMI of subjects in AfperFit group compared to placebo (p< 0.01). The safety evaluation showed that biochemical and hematological parameters were in the normal range. Supplementation of AfperFit was well tolerated during the study and no adverse effects were observed.Conclusion: Overall, this study validates the health benefits of A. melegueta seed extract as fat burner and recommends its use as a functional ingredient to improve the quality of life and general health.Keywords: grains of paradise, fat burner, 6-paradol, visceral fat
