In-house study. Dr. Khanna, et al., LCBS-VH-40, Mar, 2020.

Objectives: The study was intended to evaluate the thermogenic effect of AfperFit™ (Aframomum melegueta extract powder) in comparison placebo on body fat loss, in overweight subjects.

Methodology: This was a double blind, randomized (1:1), placebo controlled, parallel group, two arm study. A total of 70 overweight subjects were randomized into the study with 35 each in 2 treatment arms:

• AfperFit™ and placebo, receiving 250 mg capsules twice a day. Subjects self-administered
• AfperFit™ or placebo capsules orally, two time a day orally; in morning and night 30 minutes before breakfast and dinner.

Subjects were requested to adhere with their routine diet and exercise regimen throughout the study. Post fasting blood sample collection (Lipid profile and safety assessment [complete blood count (CBC), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Serum creatinine] was done. Energy expenditure and resting metabolic rate were assessed by indirect calorimetry. Anthropometric measurements recording (height, weight, body mass index (BMI), and waist to hip ratio) were recorded. Body composition and fat distribution were measured by DXA (body fat %, total body mass, fat mass, fat free mass) and by CT scan (visceral fat, sub-cutaneous fat, total fat area). Assessment of quality of life was made by administrating SF-12 questionnaire. The study was conducted in 3 visits over a period of 12 weeks.

Results: A significant increase in energy expenditure was observed in the AfperFit™ (PP) group subjects. In Placebo group subjects, a non-significant increase at end of study (EOS) was observed. A significant decrease in tissue mass was noted in PP group subjects compared to Placebo from baseline at the EOS. Similarly, a significant decrease in fat free mass was noted in PP group compared to Placebo group subjects where an increase was noted from baseline at the EOS in the PP population. A significant reduction in Visceral Fat area from baseline was observed in the PP group subjects compared to an increase in Placebo group at the EOS in the PP population. A significant decrease in Body weight from baseline was observed in the PP group subjects compared Placebo group at the EOS in the PP population. A significant decrease in Body mass index from baseline was observed in the PP group subjects compared Placebo group at the EOS in the PP population. A significant improvement in quality of life assessed by SF-12 scoring from baseline was noted in the PP group subjects compared to placebo group at the EOS. None of the subject reported any serious adverse event or was withdrawn from the study due to an adverse event or a serious adverse event. Overall, the safety and tolerability of AfperFit™ was confirmed by the various safety assessments in comparison with placebo in overweight subjects.

Conclusion :

Based on the findings of the study, the efficacy of AfperFit™ 250 mg twice a day compared to Placebo was demonstrated based on the significant increase in energy expenditure, reduction in body composition parameters (tissue mass and fat free mass), along with reduction in fat distribution (visceral fat area), body weight, body mass index and improvement in quality of life. The product was also confirmed to be safe and well tolerated in comparison with Placebo in overweight subjects.