Clinical Trials Directory

Trials / Completed

CompletedNCT07041853

The Effects of KSM-66 Ashwagandha Supplementation on Recovery and Muscle Strength in Academy Athletes

The Effects of KSM-66 Ashwagandha (Withania Somnifera) Supplementation on Recovery and Muscle Strength in Academy Athletes

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
56 (actual)
Sponsor
University Ramon Llull · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

This double-blind, randomised, placebo-controlled trial will examine the effects of 42-day root extract ashwagandha (KSM-66) supplementation on recovery and muscle strength in male and female rugby and water polo players. Participants will receive either 600 mg of ashwagandha or a placebo daily. Outcomes include hormonal stress markers, perceived exertion, wellness, muscle soreness and strength and performance metrics (grip strength, jump tests, 1RM lifts, Bronco test).

Detailed description

This double-blind, randomised, placebo-controlled trial aims to investigate the effects of ashwagandha (ASH) supplementation on recovery and muscle strength in male and female rugby and water polo players. Participants will supplement either KSM-66 ashwagandha (600 mg, standardised to 5% withanolides) or a placebo once daily for 42 days. The study will evaluate outcomes related to hormonal stress markers, perceived exertion, wellness, muscle soreness, and physical performance. Primary biomarkers include cortisol, DHEA-S, testosterone, melatonin, alpha-amylase, and cortisone, assessed through saliva samples. Subjective measures will include the Borg Rate of Perceived Exertion Scale and the Hooper Index for sleep quality, stress, fatigue, and delayed onset muscle soreness (DOMS). Physical performance will be assessed using grip strength (CAMRY dynamometer), vertical jump tests (countermovement jump, squat jump), broad jump, 1-repetition maximum (1RM) tests for deadlift, bench press, and pull-up, as well as the Bronco test. Supplement satisfaction will be evaluated via questionnaire. Participants' dietary intake will be recorded using a self-tracking method (Snap-N-Send) and analysed using Nutritics software; food diaries will serve as covariates in the final analysis. The study will be conducted in partnership with CN Poble Nou, a professional sports club in Barcelona, Spain. Ashwagandha use is increasingly common among athletes despite limited evidence on appropriate dosing and performance outcomes. This study will contribute to scientific understanding of its potential short-term benefits, particularly in high-contact sports where managing cortisol and recovery is critical. All participants will provide informed consent, and ethical considerations focus on safety, data privacy, and the right to withdraw from the study at any time.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTKSM-66 AshwagandhaRoot extract ashwagandha, KSM-66
DIETARY_SUPPLEMENTPlaceboOrganic chickpea flour

Timeline

Start date
2025-06-12
Primary completion
2025-07-31
Completion
2025-08-25
First posted
2025-06-27
Last updated
2025-09-02

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT07041853. Inclusion in this directory is not an endorsement.