A Randomized, Placebo-controlled Trial to Screen the Protein Amplifying Effect of Proprietary Botanicals for Increasing Muscle Strength & Growth

Rekha Patel¹ and Archana Gujja^2,

¹New product development department, Enovate Biolife, Mumbai- 400607, India

²Clinical development department, Vedic Lifesciences Pvt. Ltd., Mumbai- 400607, India

Cite this paper:
Rekha Patel and Archana Gujja. A Randomized, Placebo-controlled Trial to Screen the Protein Amplifying Effect of Proprietary Botanicals for Increasing Muscle Strength & Growth. American Journal of Sports Science and Medicine. 2025; 13(1):16-23. doi: 10.12691/ajssm-13-1-3

Abstract

Protein is crucial for muscle strength but typically requires weeks to show effects. This study evaluated botanical extracts for enhancing and accelerating muscle development. Twenty-six participants were randomized into five arms: EB-MS-01 (300 mg Microcrystalline cellulose (MCC) without exercise), EB-MS-02 (300 mg MCC with exercise), EB-MS-03 (500 mg Phyllanthus amarus with exercise), EB-MS-04 (250 mg Cinnamomum verum with exercise), and EB-MS-05 (350 mg Ocimum sanctum + Rosmarinus officinalis with exercise). Participants consumed two Investigational Products (IP) capsules before breakfast, and 24 gm whey protein (WP) with breakfast and dinner. IP intake ceased for responders with a ≥10% increase in muscle strength, as assessed by 1-repetition maximum (1-RM) at day 28, while the remaining participants continued the study until day 56. Outcomes included changes in muscle strength, body composition via DEXA, thigh muscle girth, fatigue using VAS-Fatigue scale, and sleep quality by modified Insomnia Severity Index. Safety was monitored for digestive system adverse effects. At end of the study, EB-MS-03 group showed a 13.05% increase in 1-RM, whereas those in the EB-MS-02, EB-MS-04 and EB-MS-05 groups experienced an increase of 9.65%, 12.78%, and 9.39%, respectively. EB-MS-03 group showed a meaningful decrease in body fat, visceral fat, android fat and an increase in lean body mass. No serious adverse events were reported, though some participants experienced mild digestive discomfort unrelated to IP. The proof-of-concept study concluded that EB-MS-03 with WP, increased muscle strength compared to WP alone. Future studies will involve a larger sample size and longer duration for more comprehensive results.

Keywords:
1-repetition maximum Muscle strength Whey protein Muscle mass Phyllanthus amarus

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