Effect of a Phytochemical formulation on Muscle fatigue, Energy, Recovery in Delayed Onset Muscle Soreness (DOMS), inflammation and Stress in Healthy Subjects: Results from a Randomized Placebo Controlled Study

Author(s): Aurea Biolabs, Anupam Paliwal, Blake Kraemer, Dhara Shah, Ishita Basera, Akhil Mukim, Vaishal Sheth, Milan Satia

Objective: To assess the effectiveness and safety of β-caryophyllene (Rephyll®) on muscle fatigue, energy, recovery in delayed onset muscle soreness (DOMS), inflammation and stress in healthy subjects.

Methods: A randomized, double-blind, placebo-controlled, clinical study was conducted by administering Rephyll® capsules or placebo capsules in the treatment of DOMS as daily supplements in 110 subjects, who were untrained in resistance or power exercise. The study subjects were randomized in a 1:1 ratio to receive either Rephyll® or placebo for 30 days. Main outcome measures were changes in muscle fatigue by fatigue index, the rating of perceived exertion (RPE) and Creatine Kinase levels. Respiratory exchange ratio (RER) and VO2max, adenosine-5’-triphosphate (ATP) and lactic acid threshold were measured for endurance of energy supply & recovery. The subjective pain score was measured using the Visual analogue scale (VAS). All evaluations were carried out between baseline and 30 days after the completion of treatment. Safety parameters were assessed by evaluating biochemical parameters for liver function, kidney function & metabolic parameters and monitoring adverse events throughout the study period.

Results: The muscle fatigue was significantly improved with Rephyll® treatment as compared to the placebo after 30 days of treatment. The Rephyll® group had a significantly lower respiratory exchange ratio than the placebo group, indicating better aerobic function. The Rephyll® group had a higher reserve of ATP compared to the placebo group after 30 days of treatment. Additionally, the Rephyll® group consumed less oxygen than the placebo group, demonstrating the product's aerobic efficiency. Increased endurance is a result of Rephyll's capacity to improve the body's ability to expel lactic acid during exercise. The Rephyll® group showed statistically significant pain reduction after 30 days of treatment at each visit as compared to placebo group. No adverse events were recorded during the study period in any of the groups.

Conclusion: Rephyll® was able to reduce muscle fatigue, improve endurance & energy supply, and showed potential for reducing DOMS. It also enhanced neuromuscular activation and reduced inflammation and stress in subjects receiving Rephyll® treatment. It was safe and well tolerated by all subjects.

CTRI Registration: CTRI/2022/06/043370