RecoveryNCT07041853
The Effects of KSM-66 Ashwagandha Supplementation on Recovery and Muscle Strength in Academy Athletes
A study testing KSM-66 Ashwagandha in people with Recovery and Strength, run by University Ramon Llull at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Recovery, Strength, Exercise Training
- What is being tested?
- KSM-66 Ashwagandha
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteSpain
- Study dates
- 12 Jun 2025to 25 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Above the age of 18
- Healthy and free of disease
- Assigned as an athlete at CN Poble Nou sports academy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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
- Recovery, Strength, Exercise Training
- Being tested
- KSM-66 Ashwagandha, Placebo
- Keywords
- ashwagandha, athlete, recovery, performance, cortisol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KSM-66 AshwagandhaDietary supplement
Root extract ashwagandha, KSM-66
PlaceboDietary supplement
Organic chickpea flour
| Study group | Role | What they receive |
|---|---|---|
| KSM-66 Ashwagandha | Experimental | 600mg root extract KSM-66 Ashwagandha, once daily taken with dinner Receives: Dietary Supplement: KSM-66 Ashwagandha |
| Placebo | Placebo comparator | 600mg organic chickpea flour, once daily taken with dinner Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortisol
Salivary cortisol
Measured: Baseline and final measurement at 6 weeks
Hand grip
Hand grip strength in kilograms, CAMRY dynanometer
Measured: Baseline and final measurement at 6 weeks
Secondary outcomes (6)
Testosterone
Salivary testosterone
Measured: Baseline and final measurement at 6 weeks
Melatonin
Salivary melatonin
Measured: Baseline and final measurement at 6 weeks
DHEA-s
Salivary DHEA-s
Measured: Baseline and final measurement at 6 weeks
Alpha-amylase
Salivary alpha-amylase
Measured: Baseline and final measurement at 6 weeks
Cortisone
Salivary cortisone
Measured: Baseline and final measurement at 6 weeks
Bronco test
Aerobic fitness test in minutes and seconds
Measured: Baseline and final measurement at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start12 Jun 2025
- Primary completion31 Jul 2025
- Study completion25 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RecoveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ramon Llull
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blanca Roman-Viñas, MD, University Ramon Llull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041853
- Sponsor's protocol ID
- 05-03-2025
- Status last verified
- Aug 2025
- First submitted
- 19 Jun 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be made available upon reasonable request for academic research purposes.
Publications
Coope OC, Otaegui E, Suarez M, Levington A, Abad-Sangra M, Lloyd B, Spurr TJ, Roman-Vinas B. Ashwagandha Root Extract Stabilises Physiological Stress Responses in Male and Female Team Sports Athletes During Pre-Season Training. Nutrients. 2026 Jan 12;18(2):230. doi: 10.3390/nu18020230.
PubMed 41599843
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of KSM-66 Ashwagandha (Withania Somnifera) Supplementation on Recovery and Muscle Strength in Academy Athletes
- ClinicalTrials.gov ID
- NCT07041853
- Acronym / sponsor ID
- 05-03-2025
- Conditions
- Recovery, Strength, Exercise Training
- Keywords
- ashwagandha, athlete, recovery, performance, cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Ramon LlullUniversity, hospital or other
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 25 Aug 2025 (actual)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KSM-66 Ashwagandha | Experimental | Dietary Supplement: KSM-66 Ashwagandha600mg root extract KSM-66 Ashwagandha, once daily taken with dinner |
| Placebo | Placebo comparator | Dietary Supplement: Placebo600mg organic chickpea flour, once daily taken with dinner |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Above the age of 18
- Healthy and free of disease
- Assigned as an athlete at CN Poble Nou sports academy
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KSM-66 AshwagandhaRoot extract ashwagandha, KSM-66 | Dietary supplement | KSM-66 Ashwagandha |
| PlaceboOrganic chickpea flour | Dietary supplement | Placebo |
Primary outcome
Cortisol
Time frame: Baseline and final measurement at 6 weeks
Salivary cortisol
Hand grip
Time frame: Baseline and final measurement at 6 weeks
Hand grip strength in kilograms, CAMRY dynanometer
6 secondary outcomes
Testosterone
Time frame: Baseline and final measurement at 6 weeks
Melatonin
Time frame: Baseline and final measurement at 6 weeks
DHEA-s
Time frame: Baseline and final measurement at 6 weeks
Alpha-amylase
Time frame: Baseline and final measurement at 6 weeks
Cortisone
Time frame: Baseline and final measurement at 6 weeks
Bronco test
Time frame: Baseline and final measurement at 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Derived from this study: PubMed 41599843Coope OC, Otaegui E, Suarez M, Levington A, Abad-Sangra M, Lloyd B, Spurr TJ, Roman-Vinas B. Ashwagandha Root Extract Stabilises Physiological Stress Responses in Male and Female Team Sports Athletes During Pre-Season Training. Nutrients. 2026 Jan 12;18(2):230. doi: 10.3390/nu18020230.
- Individual participant dataSharing planned: Yes. IPD will be made available upon reasonable request for academic research purposes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KSM-66 Ashwagandha in people with Recovery and Strength, run by University Ramon Llull at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cortisol (time frame: Baseline and final measurement at 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07041853, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.