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

August 29, 2025 updated by: Blanca Roman-Viñas, MD, University Ramon Llull

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

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).

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Barcelona, Spain
        • Club Natació Poble Nou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Above the age of 18
  • Healthy and free of disease
  • Assigned as an athlete at CN Poble Nou sports academy

Exclusion Criteria:

  • Allergies to nightshades such as tomato, aubergine, potatoes and peppers
  • Active supplementation with other ergogenic aids (to not interfere with existing treatment)
  • Medication or contraceptives (to not interfere with existing treatment)
  • Liver conditions (to not interfere with existing treatment)
  • Thyroid conditions (to not interfere with existing treatment)
  • Diabetes or certain autoimmune conditions (to not interfere with existing treatment)
  • Active pregnancy (to not interfere with existing treatment)
  • No signing of the consent form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: KSM-66 Ashwagandha
600mg root extract KSM-66 Ashwagandha, once daily taken with dinner
Root extract ashwagandha, KSM-66
Placebo Comparator: Placebo
600mg organic chickpea flour, once daily taken with dinner
Organic chickpea flour

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cortisol
Time Frame: Baseline and final measurement at 6 weeks
Salivary cortisol
Baseline and final measurement at 6 weeks
Hand grip
Time Frame: Baseline and final measurement at 6 weeks
Hand grip strength in kilograms, CAMRY dynanometer
Baseline and final measurement at 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Testosterone
Time Frame: Baseline and final measurement at 6 weeks
Salivary testosterone
Baseline and final measurement at 6 weeks
Melatonin
Time Frame: Baseline and final measurement at 6 weeks
Salivary melatonin
Baseline and final measurement at 6 weeks
DHEA-s
Time Frame: Baseline and final measurement at 6 weeks
Salivary DHEA-s
Baseline and final measurement at 6 weeks
Alpha-amylase
Time Frame: Baseline and final measurement at 6 weeks
Salivary alpha-amylase
Baseline and final measurement at 6 weeks
Cortisone
Time Frame: Baseline and final measurement at 6 weeks
Salivary cortisone
Baseline and final measurement at 6 weeks
Bronco test
Time Frame: Baseline and final measurement at 6 weeks
Aerobic fitness test in minutes and seconds
Baseline and final measurement at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2025

Primary Completion (Actual)

July 31, 2025

Study Completion (Actual)

August 25, 2025

Study Registration Dates

First Submitted

June 19, 2025

First Submitted That Met QC Criteria

June 19, 2025

First Posted (Actual)

June 27, 2025

Study Record Updates

Last Update Posted (Estimated)

September 2, 2025

Last Update Submitted That Met QC Criteria

August 29, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 05-03-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be made available upon reasonable request for academic research purposes.

IPD Sharing Supporting Information Type

  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Recovery

Clinical Trials on KSM-66 Ashwagandha

Subscribe