PerformanceNCT07343219
Effects of Root Extract Ashwagandha (KSM-66) on Physiological Stress, Perception of Recovery and Muscle Strength in Youth Footballers
A study testing Root extract Ashwagandha and Corn Starch in people with Performance and Recovery, run by Sports Performance and Applied Research in Trials and Analysis at 1 site in United Kingdom.
Trial summary
This trial examines if six weeks of taking 450 mg Ashwagandha root extract affects exercise performance and recovery in youth male elite football players. Ashwagandha root extract is increasingly used by athletes, but controlled research in adolescent athletes is limited and the majority of evidence is in an adult… Read more about this study
- Who is it for?
- Ages 12 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Performance, Recovery, Strength
- What is being tested?
- Root extract Ashwagandha and Corn Starch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jan 2026to 18 Jul 2026
- 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 12 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male youth football player
- Classified as 'healthy' and 'free of disease'
- Actively training with the selected football academy
Who cannot join
- Lack of signed consent form
- No active use of medication
- No active use of ergogenic aids
- Allergies to nightshades
Trial locations and contacts
1 site in 1 country.
About this study
This trial examines if six weeks of taking 450 mg Ashwagandha root extract affects exercise performance and recovery in youth male elite football players.
Ashwagandha root extract is increasingly used by athletes, but controlled research in adolescent athletes is limited and the majority of evidence is in an adult population. This study will assess short-term responses in youth players.
Participants will be randomly assigned to take either Ashwagandha root extract or a placebo once daily for six weeks. Players will complete training-based tests, provide saliva samples and complete a short, validated questionnaire on perception of wellness. Any adverse events will be documented and reported.
Read the detailed description
The objective of this trial is to learn whether a short period of taking 450mg of Ashwagandha root extract affects performance, recovery, muscle strength and wellbeing in youth male elite football players.
The researchers are studying Ashwagandha root extract as it is increasingly used by athletes and the general population of varying ages for well-being, performance and recovery purposes, despite a lack of controlled research examining its effects in adolescent athletes. Most existing evidence comes from adult populations, and it remains unclear whether similar physiological and perceptual responses occur in adolescents engaged in structured training.
The main questions the study aims to answer are:
Does taking Ashwagandha root extract change stress levels measured through saliva in youth elite footballers?
Does it affect muscle strength, recovery, sleep, or muscle soreness?
Participants will be randomly assigned to take either Ashwagandha root extract or a placebo once a day for six weeks. During the study, players will complete strength and fitness tests during usual training time, then provide saliva samples afterwards. Short questionnaires will be solicited the day after about how they feel. Any adverse events that occur during the study will be documented and reported.
- Conditions
- Performance, Recovery, Strength, Aerobic Endurance
- Being tested
- Root extract Ashwagandha, Corn Starch
- Keywords
- ashwagandha, football, strength, recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root extract AshwagandhaDietary supplement
450 mg Ashwagandha root extract
Corn StarchOther
450 mg corn starch
| Study group | Role | What they receive |
|---|---|---|
| Ashwagandha root extract | Experimental | 450 mg Ashwagandha root extract Receives: Dietary Supplement: Root extract Ashwagandha |
| Placebo | Placebo comparator | 450 mg corn starch Receives: Other: Corn Starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Salivary Cortisol Concentration from Baseline to 6 Weeks
Measured: 6 weeks
Secondary outcomes (9)
Change in Salivary Alpha Amylase from Baseline to 6 Weeks
Measured: 6 weeks
Change in Handgrip Strength (kg) from Baseline to 6 Weeks
Hand grip strength using CAMRY dynamometer
Measured: 6 weeks
Change in Countermovement Jump Height (cm) from Baseline to 6 Weeks
Measured: 6 weeks
Change in 1 km Time Trial Completion Time (seconds) from Baseline to 6 Weeks
Maximal effort run of 1km
Measured: 6 weeks
Perception of sleep quality
Sleep quality will be assessed using the sleep domain of the Hooper Index, which is one of four domains within the questionnaire (fatigue, stress, delayed onset muscle soreness, and sleep). The sleep item is rated on a 10-point scale (1 to 10), where 1 indicates very, very good sleep and 10 indicates very, very poor sleep. This domain will be analysed independently as a subset of the Hooper Index, rather than as part of the total score.
Measured: Baseline to 6 weeks
Perception of stress
Perceived stress will be assessed using the sleep domain of the Hooper Index, which is one of four domains within the questionnaire (fatigue, stress, delayed onset muscle soreness and sleep). The stress item is rated on a 10-point scale (1 to 10), where 1 indicates very, very good and 10 indicates very, very poor. This domain will be analysed independently as a subset of the Hooper Index, rather than as part of the total score.
Measured: Baseline to 6 weeks
Perception of muscle soreness
Perceived muscle soreness will be assessed using the sleep domain of the Hooper Index, which is one of four domains within the questionnaire (fatigue, stress, delayed onset muscle soreness and sleep). The muscle soreness item is rated on a 10-point scale (1 to 10), where 1 indicates very, very good and 10 indicates very, very poor. This domain will be analysed independently as a subset of the Hooper Index, rather than as part of the total score.
Measured: Baseline to 6 weeks
Perception of fatigue
Perceived fatigue will be assessed using the sleep domain of the Hooper Index, which is one of four domains within the questionnaire (fatigue, stress, delayed onset muscle soreness and sleep). The fatigue item is rated on a 10-point scale (1 to 10), where 1 indicates very, very good and 10 indicates very, very poor. This domain will be analysed independently as a subset of the Hooper Index, rather than as part of the total score.
Measured: Baseline to 6 weeks
Overall Hooper Index Score
Perceived recovery will be assessed using the Hooper Index, which evaluates four domains: fatigue, stress, delayed onset muscle soreness (DOMS) and sleep quality. Each domain is rated on a 10-point scale (1 to 10), where 1 indicates very, very good and 10 indicates very, very poor. The total Hooper Index score is calculated by summing the four domains, resulting in a possible range of 4 to 40, with higher scores indicating worse perceived recovery, greater fatigue and stress, and lower scores indicating better recovery.
Measured: Baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start6 Jan 2026
- Primary completion17 Jul 2026 (estimated)
- Study completion18 Jul 2026 (estimated)
Why it stopped: Finalising ethics approval before completing.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PerformanceStudies 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
- Model description
- Randomised, double-blind and placebo-controlled clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sports Performance and Applied Research in Trials and Analysis
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Olivia C Coope, PhD, Study director, Blanquerna Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343219
- Sponsor's protocol ID
- 20251103
- Status last verified
- May 2026
- First submitted
- 6 Jan 2026
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data related to primary and secondary outcomes will be shared with other sports nutrition researchers upon reasonable request. Data sharing will be subject to ethical approval, data protection requirements, and safeguarding considerations, and will exclude any information that could identify participants.
Publications
Bonilla DA, Moreno Y, Gho C, Petro JL, Odriozola-Martinez A, Kreider RB. Effects of Ashwagandha (Withania somnifera) on Physical Performance: Systematic Review and Bayesian Meta-Analysis. J Funct Morphol Kinesiol. 2021 Feb 11;6(1):20. doi: 10.3390/jfmk6010020.
PubMed 33670194Mishra RK, Trivedi R, Pandya MA. A clinical study of Ashwagandha ghrita and Ashwagandha granules for its Brumhana and Balya effect. Ayu. 2010 Jul;31(3):355-60. doi: 10.4103/0974-8520.77164.
PubMed 22131739Petroczi A, Naughton DP, Pearce G, Bailey R, Bloodworth A, McNamee M. Nutritional supplement use by elite young UK athletes: fallacies of advice regarding efficacy. J Int Soc Sports Nutr. 2008 Dec 15;5:22. doi: 10.1186/1550-2783-5-22.
PubMed 19077317
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Root Extract Ashwagandha (KSM-66) on Physiological Stress, Perception of Recovery and Muscle Strength in Youth Footballers
- ClinicalTrials.gov ID
- NCT07343219
- Acronym / sponsor ID
- 20251103
- Conditions
- Performance, Recovery, Strength, Aerobic Endurance
- Keywords
- ashwagandha, football, strength, recovery
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Finalising ethics approval before completing.
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Sports Performance and Applied Research in Trials and AnalysisResearch network
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- 17 Jul 2026 (estimated)
- Study completion
- 18 Jul 2026 (estimated)
- First posted
- 15 Jan 2026 (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 trial examines if six weeks of taking 450 mg Ashwagandha root extract affects exercise performance and recovery in youth male elite football players.
Ashwagandha root extract is increasingly used by athletes, but controlled research in adolescent athletes is limited and the majority of evidence is in an adult population. This study will assess short-term responses in youth players.
Participants will be randomly assigned to take either Ashwagandha root extract or a placebo once daily for six weeks. Players will complete training-based tests, provide saliva samples and complete a short, validated questionnaire on perception of wellness. Any adverse events will be documented and reported.
Detailed description
The objective of this trial is to learn whether a short period of taking 450mg of Ashwagandha root extract affects performance, recovery, muscle strength and wellbeing in youth male elite football players.
The researchers are studying Ashwagandha root extract as it is increasingly used by athletes and the general population of varying ages for well-being, performance and recovery purposes, despite a lack of controlled research examining its effects in adolescent athletes. Most existing evidence comes from adult populations, and it remains unclear whether similar physiological and perceptual responses occur in adolescents engaged in structured training.
The main questions the study aims to answer are:
Does taking Ashwagandha root extract change stress levels measured through saliva in youth elite footballers?
Does it affect muscle strength, recovery, sleep, or muscle soreness?
Participants will be randomly assigned to take either Ashwagandha root extract or a placebo once a day for six weeks. During the study, players will complete strength and fitness tests during usual training time, then provide saliva samples afterwards. Short questionnaires will be solicited the day after about how they feel. Any adverse events that occur during the study will be documented and reported.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Randomised, double-blind and placebo-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Ashwagandha root extract | Experimental | Dietary Supplement: Root extract Ashwagandha450 mg Ashwagandha root extract |
| Placebo | Placebo comparator | Other: Corn Starch450 mg corn starch |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Male youth football player
- Classified as 'healthy' and 'free of disease'
- Actively training with the selected football academy
Key exclusion criteria (4 listed)
- Lack of signed consent form
- No active use of medication
- No active use of ergogenic aids
- Allergies to nightshades
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 |
|---|---|---|
| Root extract Ashwagandha450 mg Ashwagandha root extract | Dietary supplement | Ashwagandha root extract |
| Corn Starch450 mg corn starch | Other | Placebo |
Primary outcome
Change in Salivary Cortisol Concentration from Baseline to 6 Weeks
Time frame: 6 weeks
9 secondary outcomes
Change in Salivary Alpha Amylase from Baseline to 6 Weeks
Time frame: 6 weeks
Change in Handgrip Strength (kg) from Baseline to 6 Weeks
Time frame: 6 weeks
Change in Countermovement Jump Height (cm) from Baseline to 6 Weeks
Time frame: 6 weeks
Change in 1 km Time Trial Completion Time (seconds) from Baseline to 6 Weeks
Time frame: 6 weeks
Perception of sleep quality
Time frame: Baseline to 6 weeks
Perception of stress
Time frame: Baseline to 6 weeks
Perception of muscle soreness
Time frame: Baseline to 6 weeks
Perception of fatigue
Time frame: Baseline to 6 weeks
Overall Hooper Index Score
Time frame: Baseline to 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Background: PubMed 33670194Bonilla DA, Moreno Y, Gho C, Petro JL, Odriozola-Martinez A, Kreider RB. Effects of Ashwagandha (Withania somnifera) on Physical Performance: Systematic Review and Bayesian Meta-Analysis. J Funct Morphol Kinesiol. 2021 Feb 11;6(1):20. doi: 10.3390/jfmk6010020.
- Background: PubMed 22131739Mishra RK, Trivedi R, Pandya MA. A clinical study of Ashwagandha ghrita and Ashwagandha granules for its Brumhana and Balya effect. Ayu. 2010 Jul;31(3):355-60. doi: 10.4103/0974-8520.77164.
- Background: PubMed 19077317Petroczi A, Naughton DP, Pearce G, Bailey R, Bloodworth A, McNamee M. Nutritional supplement use by elite young UK athletes: fallacies of advice regarding efficacy. J Int Soc Sports Nutr. 2008 Dec 15;5:22. doi: 10.1186/1550-2783-5-22.
- Individual participant dataSharing planned: Yes. De-identified individual participant data related to primary and secondary outcomes will be shared with other sports nutrition researchers upon reasonable request. Data sharing will be subject to ethical approval, data protection requirements, and safeguarding considerations, and will exclude any information that could identify participants.
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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.
Olivia C Coope, PhD study director
Blanquerna Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Root extract Ashwagandha and Corn Starch in people with Performance and Recovery, run by Sports Performance and Applied Research in Trials and Analysis at 1 site in United Kingdom.
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 4 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: paused, as of the sponsor's last update on 15 May 2026. 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 United Kingdom. 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?
Results are not available in the source record.
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?
Change in Salivary Cortisol Concentration from Baseline to 6 Weeks (time frame: 6 weeks). 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 NCT07343219, which also lists 3 linked publications.
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 15 May 2026.