Transl Clin Pharmacol.  2023 Mar;31(1):13-27. 10.12793/tcp.2023.31.e1.

Efficacy and safety assessment of protein supplement - micronutrient fortification in promoting health and wellbeing in healthy adults -a randomized placebo-controlled trial

• Ambulkar P
• Hande P
• Tambe B
• Vaidya VGV
• Naik N
• Agarwal R
• i Ganu G

• KMID: 2552403
• DOI: http://doi.org/10.12793/tcp.2023.31.e1

Abstract

Protein supplements are extensively used for muscle building, weight loss, recovery from exercise, improving endurance & cardio-performance. Major challenge with protein supplement is undigested protein and impaired gut health which results in nausea, dehydration, diarrhea, constipation, indigestion, stomach pain, and decreased appetite. Several studies have linked plant protein with reduced metabolic syndrome incidence. Probiotics can improve gut health as well. The objective of the study is to assess the efficacy and safety of protein supplement in promoting health and wellbeing in healthy adults. The present trial is a double blind, multi-center, randomized, placebo controlled, clinical trial involving 60 healthy individuals. The treatment duration was of 90 days. The subjects were randomized to receive either protein supplement treatment or placebo control. Protein supplement significantly improved quality-of-life score by 85.76%, VO 2 max by 42.92%, distance covered in 6 minutes, 100% individuals with at least 25% reduction in low energy events as compared to the control group. Protein supplement treatment reduced body weight (1.94 kg), waist circumference (2.46 cm), body mass index, waist circumference, hip circumference and body fat. Remarkable and significant improvement in digestive and sleep quality score, percent skeletal muscle was observed among protein supplement treated group. There were no clinically significant changes in hematological, biochemical and vital parameters; indicating safety of protein supplement. Present study concluded that protein supplement is safe and efficacious in weight management, improving high energy events, aerobic capacity, quality of life, digestive behavior score and sleep quality. This study ensures consumers about safety and effectiveness of protein supplement.

Keyword

Protein; Probiotic; Endurance; Oxygen Consumption