- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07041853
- Original Trial
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Barcelona, Spain
- Club Natació Poble Nou
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 05-03-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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