Abstract
BACKGROUND: Sarcopenia is associated with chronic inflammation, a sedentary lifestyle, and ageing. However, there exists no drug, which is safe and effective for long-term use. Ashwagandha (Withaniasomnifera (L.) Dunal) has the potential to fill this therapeutic gap based on its efficacy and safety profile; hence, the present study was planned to evaluate its effect on inflammatory biomarkers and muscle status in healthy volunteers. METHODOLOGY: A prospective, double-blind, randomized, placebo-controlled clinical study was conducted to evaluate the effects of Ashwagandha extract in healthy volunteers (February 2021 to May 2022) who received either Ashwagandha extract tablets 250 mg or a placebo twice daily for 60 days. The physical performance on a bicycle ergometer, inflammatory/muscle status biomarkers, body composition, reaction time, hemogram, and organ function tests was assessed at baseline, day 30, and day 60. RESULTS: In the Ashwagandha group, there was a statistically significant (p<0.05) improvement in total distance travelled (Ashwagandha 2.85 ± 0.54 km vs placebo 2.16 ± 0.62 km), average speed achieved (Ashwagandha 25.6 ± 5.7 km/hour vs placebo 22.2 ± 5.48 km/hour) on a bicycle ergometer from the baseline visit (V3) to the last visit (V7) as compared to the placebo group. The observations on hand-grip strength, back-leg press, skeletal muscle mass, and VO(2) max showed an increasing trend from V3 to V7, whereas the results of the three inflammatory markers (hs-C-reactive protein (CRP) mg/L; IL-6; TNF-alpha ) and the muscle marker (myostatin) revealed a decreasing trend from V3 to V7 in the Ashwagandha group. Ashwagandha extract was found to be safe in healthy volunteers as evidenced by the clinical profile, laboratory investigations, and reaction time test. CONCLUSION: Ashwagandha extract supplementation was safe and effective in enhancing physical performance and strengthening muscle mass and could be a potential candidate for treating sarcopenia.