Muscle StrengthNCT06264986
The Effects of Ashwagandha (Withania Somnifera) Supplementation on Exercise Performance in Female Footballers
A study testing Ashwagandha in people with Muscle Strength, run by Blanca Roman-Viñas, MD at 1 site in Spain.
Trial summary
The goal of this clinical trial is to evaluate the effects of short-term root extract ashwagandha supplementation on exercise performance in female footballers. The main question it aims to answer are: Will short-term supplementation of root extract ashwagandha improve muscle strength markers in female footballers?… Read more about this study
- Who is it for?
- Ages 17 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Strength
- What is being tested?
- Ashwagandha
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 13 Jan 2024to 27 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Female
- Playing football professionally
- At a sub-elite to elite standard
- Healthy and free of disease
Who cannot join
- Active supplementation with other ergogenic aids
- Medication or contraceptives (to not interfere with existing treatment)
- Thyroid conditions (due to interaction with cortisol)
- Diabetes or certain autoimmune conditions (to not interfere with existing treatment)
- Active pregnancy (to not interfere with existing treatment)
- Allergies to nightshades such as tomato, aubergine, potatoes and peppers
- No signing of the consent form
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to evaluate the effects of short-term root extract ashwagandha supplementation on exercise performance in female footballers. The main question it aims to answer are:
Will short-term supplementation of root extract ashwagandha improve muscle strength markers in female footballers? Will short-term supplementation of root extract ashwagandha improve perception of recovery following high-intensity exercise in female footballers?
Participants will either supplement 600mg (5% withanolides) root extract ashwagandha or placebo once a day for 28 days. There will be three data points: baseline, 14 days and 28 days. Researchers will compare values of intervention against placebo to see if there is an effect on muscle strength or perception of recovery.
Read the detailed description
The objectives of the thesis are to determine the effects of ashwagandha (ASH) on muscle strength, muscle recovery and to assess habitual dietary intake of female footballers. Across one phase, two experimental research papers and one descriptive research paper will be produced; it will involve one double-blind, randomised and placebo-controlled trial and a comparative analysis of nutritional intake in female footballers. The thesis will involve participants supplementing ASH in the form of a capsule containing KSM-66 (600 mg with 30mg withanolides) or placebo once a day for 28 days, on a singular occasion. The objectives of the first two papers are to determine the effects of ASH on muscle strength, perception of recovery, perception of exertion, perceived wellness and perceived muscle soreness. For the paper on muscle strength, the methodology will include hand grip test, counter movement jump (CMJ), squat jump (SJ), peak power, medicine ball throw and rate of perceived exertion (RPE) via the Borg Scale. For the paper on muscle recovery, the methodology will include a questionnaire on sleep, stress, fatigue and delayed onset of muscle soreness (DOMS) test via the Hooper Index (HI), total quality recovery (TQR) questionnaire and a supplement satisfaction questionnaire. The objectives of the third paper are to evaluate the dietary intake of professional female footballers and compare the values against published nutritional recommendations. The participants diets will be tracked for purposes of the muscle strength and recovery study. The methodology will involve self-tracking of dietary intake via the Snap-N-Send method and data will be stored and analysed with the software Nutritics. The study will be conducted with a professional club in Barcelona. The use of ASH is becoming prevalent in athletes, despite lack of information regarding dosage guidelines or lack of research on its benefits for exercise performance. The proposed study will contribute to the overall scientific knowledge of ASH and whether it may demonstrate benefits from short-term use. Additionally, the study will determine if there are benefits for female athletes that wish to increase strength and reduce perception of pain or soreness related to exercise. The ethical considerations for this study are predominantly the safety and comfort of the participant. An informed consent form will be given to the participant, containing information about data collection, personal information, safety of the supplement and their right to drop out of the study at any point. The proposed start date is January 2024, and the study will aim to collectively last for 36 days across a singular phase. The supplement is provided by Zenement España, a supplement company based in Barcelona.
- Conditions
- Muscle Strength
- Being tested
- Ashwagandha, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AshwagandhaDietary supplement
Also called KSM-66, Root extract ashwagandha
The intervention will be 600mg of KSM-66, a branded supplement derived from the root extract of the herb ashwagandha, with a consistent rate of 5% withanolides for 28 days. It is the most clinically studied extract of the herb and is the only type of ashwagandha to receive third party testing certification (Informed Sport, Informed Ingredient, Banned Substances Control Group, Clean Label Project). The laboratory where the product is made, Ixoreal Biomed, has received Current Good Laboratory Practices (cGLP), quality controlled and tested against heavy metals and pesticides.
PlaceboOther
600mg chickpea flour in a hydroxypropyl methylcellulose capsule, once a day for 28 days
| Study group | Role | What they receive |
|---|---|---|
| KSM-66 | Experimental | 600mg (5% withanolides) KSM-66 ashwagandha, hydroxypropyl methylcellulose capsule Receives: Dietary Supplement: Ashwagandha |
| Placebo | Placebo comparator | 600mg Gluten-free chickpea powder, hydroxypropyl methylcellulose capsule Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased Lower Body Muscle Strength 1/2
Jump strength, assessed by Peak Power, is calculated based on jump height (in centimetres) and body mass (in kilograms) using this formula Peak power (W) = (60.7) × (jump height [cm]) + 45.3 × (body mass [kg]) - 2055 [1]. Jumps are measured using a clinically validated open-source jump mat (Chronojump Bocosystems) to ensure accuracy. The highest recorded value is used for analysis.
- Sayers, S. P.; Harackiewicz, D. V.; Harman, E. A.; Frykman, P. N.; Rosenstein, M. T. Cross-Validation of Three Jump Power Equations. Medicine and science in sports and exercise 1999, 31 (4), 572-577. https://doi.org/10.1097/00005768-199904000-00013.
Measured: 28 days
Increased Maximum Voluntary Muscle Strength
Hand grip strength. This will be measured with a CAMRY digital hand dynamometer and the unit of measurement will be kilograms.
Measured: 28 days
Increased Upper Body Muscle Strength and Explosiveness
Medicine ball throw using a 5 kilogram medicine ball. Participants will throw a medicine ball while standing. The distance of the throw will be measured in centimetres.
Measured: 28 days
Improved Overall Muscle Strength
Rate of perceived exertion (RPE) using the Borg Scale measuring the difficulty of high-intensity exercise. 1 represents a score of very light activity, and 10 represents a score of maximum effort activity.
Measured: 28 days
Increased Lower Body Muscle Strength in 2/2
Lower body muscle strength is assessed using the countermovement jump (CMJ) and squat jump (SJ) tests, two validated measures of lower body explosive power. Each participant performs a single jump for each test on a clinically validated open-source jump mat (Chronojump Bocosystems), which records jump height in centimetres. The jump mat uses precise force and time measurements to calculate height, ensuring reliable data output. Participants receive standardised instructions and a demonstration before testing to ensure consistency and accuracy.The highest recorded value is used for analysis.
Measured: 28 days
Secondary outcomes (2)
Improved Perception of Wellbeing
Hooper Index questionnaire. Participants rate their perception of sleep, stress, fatigue and muscle soreness on a scale. A score of 1 is very, very good and 10 is a score of very, very bad.
The Hooper Index questionnaire assesses participants' perception of sleep quality, stress levels, fatigue, and muscle soreness. Each item is rated on a scale from 1 to 10, where 1 represents "very, very good" and 10 represents "very, very bad." The minimum possible score for each item is 1, and the maximum possible score is 10. Higher scores indicate a worse perception of wellbeing. An overall wellbeing score is calculated by summing scores for sleep, stress, fatigue, and muscle soreness, with a total range from 4 (very good) to 40 (very bad).
Measured: 28 days
Improved Perception of Recovery
Total Quality Recovery questionnaire. Participants rate their recovery following high-intensity exercise. A score of 6 is very, very low recovery and 20 is a score of very, very good recovery.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start13 Jan 2024
- Primary completion21 Feb 2024
- Study completion27 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Muscle StrengthStudies 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
- Double-blind, placebo-controlled, randomised trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Blanca Roman-Viñas, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Blanca Roman-Viñas, MD, University Ramon Llull
- Investigators
- Blanca Roman Viñas, Principal investigator, Blanquerna, Ramon Llull University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264986
- Sponsor's protocol ID
- 2023-09-02
- Status last verified
- Jan 2025
- First submitted
- 31 Jan 2024
- Last updated
- 9 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 33670194Coope OC, Reales Salguero A, Spurr T, Paez Calvente A, Domenech Farre A, Jordan Fisas E, Lloyd B, Gooderick J, Abad Sangra M, Roman-Vinas B. Effects of Root Extract of Ashwagandha (Withania somnifera) on Perception of Recovery and Muscle Strength in Female Athletes. Eur J Sport Sci. 2025 Mar;25(3):e12265. doi: 10.1002/ejsc.12265.
PubMed 39954269
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ashwagandha (Withania Somnifera) Supplementation on Exercise Performance in Female Footballers
- ClinicalTrials.gov ID
- NCT06264986
- Acronym / sponsor ID
- 2023-09-02
- Conditions
- Muscle Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Blanca Roman-Viñas, MDUniversity, hospital or other
- Study start
- 13 Jan 2024 (actual)
- Primary completion
- 21 Feb 2024 (actual)
- Study completion
- 27 Apr 2024 (actual)
- First posted
- 20 Feb 2024 (actual)
- Results
- Posted 9 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the effects of short-term root extract ashwagandha supplementation on exercise performance in female footballers. The main question it aims to answer are:
Will short-term supplementation of root extract ashwagandha improve muscle strength markers in female footballers? Will short-term supplementation of root extract ashwagandha improve perception of recovery following high-intensity exercise in female footballers?
Participants will either supplement 600mg (5% withanolides) root extract ashwagandha or placebo once a day for 28 days. There will be three data points: baseline, 14 days and 28 days. Researchers will compare values of intervention against placebo to see if there is an effect on muscle strength or perception of recovery.
Detailed description
The objectives of the thesis are to determine the effects of ashwagandha (ASH) on muscle strength, muscle recovery and to assess habitual dietary intake of female footballers. Across one phase, two experimental research papers and one descriptive research paper will be produced; it will involve one double-blind, randomised and placebo-controlled trial and a comparative analysis of nutritional intake in female footballers. The thesis will involve participants supplementing ASH in the form of a capsule containing KSM-66 (600 mg with 30mg withanolides) or placebo once a day for 28 days, on a singular occasion. The objectives of the first two papers are to determine the effects of ASH on muscle strength, perception of recovery, perception of exertion, perceived wellness and perceived muscle soreness. For the paper on muscle strength, the methodology will include hand grip test, counter movement jump (CMJ), squat jump (SJ), peak power, medicine ball throw and rate of perceived exertion (RPE) via the Borg Scale. For the paper on muscle recovery, the methodology will include a questionnaire on sleep, stress, fatigue and delayed onset of muscle soreness (DOMS) test via the Hooper Index (HI), total quality recovery (TQR) questionnaire and a supplement satisfaction questionnaire. The objectives of the third paper are to evaluate the dietary intake of professional female footballers and compare the values against published nutritional recommendations. The participants diets will be tracked for purposes of the muscle strength and recovery study. The methodology will involve self-tracking of dietary intake via the Snap-N-Send method and data will be stored and analysed with the software Nutritics. The study will be conducted with a professional club in Barcelona. The use of ASH is becoming prevalent in athletes, despite lack of information regarding dosage guidelines or lack of research on its benefits for exercise performance. The proposed study will contribute to the overall scientific knowledge of ASH and whether it may demonstrate benefits from short-term use. Additionally, the study will determine if there are benefits for female athletes that wish to increase strength and reduce perception of pain or soreness related to exercise. The ethical considerations for this study are predominantly the safety and comfort of the participant. An informed consent form will be given to the participant, containing information about data collection, personal information, safety of the supplement and their right to drop out of the study at any point. The proposed start date is January 2024, and the study will aim to collectively last for 36 days across a singular phase. The supplement is provided by Zenement España, a supplement company based in Barcelona.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-blind, placebo-controlled, randomised trial
| Arm | Type | Receives |
|---|---|---|
| KSM-66 | Experimental | Dietary Supplement: Ashwagandha600mg (5% withanolides) KSM-66 ashwagandha, hydroxypropyl methylcellulose capsule |
| Placebo | Placebo comparator | Other: Placebo600mg Gluten-free chickpea powder, hydroxypropyl methylcellulose capsule |
Who may qualify
- Ages
- 17 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Female
- Playing football professionally
- At a sub-elite to elite standard
- Healthy and free of disease
Key exclusion criteria (7 listed)
- Active supplementation with other ergogenic aids
- Medication or contraceptives (to not interfere with existing treatment)
- Thyroid conditions (due to interaction with cortisol)
- Diabetes or certain autoimmune conditions (to not interfere with existing treatment)
- Active pregnancy (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 |
|---|---|---|
| AshwagandhaAlso: KSM-66, Root extract ashwagandhaThe intervention will be 600mg of KSM-66, a branded supplement derived from the root extract of the herb ashwagandha, with a consistent rate of 5% withanolides for 28 days. It is the most clinically studied extract of the herb and is the only type of ashwagandha to receive third party testing certification (Informed Sport, Informed Ingredient, Banned Substances Control Group, Clean Label Project). The laboratory where the product is made, Ixoreal Biomed, has received Current Good Laboratory Practices (cGLP), quality controlled and tested against heavy metals and pesticides. | Dietary supplement | KSM-66 |
| Placebo600mg chickpea flour in a hydroxypropyl methylcellulose capsule, once a day for 28 days | Other | Placebo |
Primary outcome
Increased Lower Body Muscle Strength 1/2
Time frame: 28 days
Jump strength, assessed by Peak Power, is calculated based on jump height (in centimetres) and body mass (in kilograms) using this formula Peak power (W) = (60.7) × (jump height [cm]) + 45.3 × (body mass [kg]) - 2055 [1]. Jumps are measured using a clinically validated open-source jump mat (Chronojump Bocosystems) to ensure accuracy. The highest recorded value is used for analysis. 1. Sayers, S. P.; Harackiewicz, D. V.; Harman, E. A.; Frykman, P. N.; Rosenstein, M. T. Cross-Validation of Three Jump Power Equations. Medicine and science in sports and exercise 1999, 31 (4), 572-577. https://doi.org/10.1097/00005768-199904000-00013.
Increased Maximum Voluntary Muscle Strength
Time frame: 28 days
Hand grip strength. This will be measured with a CAMRY digital hand dynamometer and the unit of measurement will be kilograms.
Increased Upper Body Muscle Strength and Explosiveness
Time frame: 28 days
Medicine ball throw using a 5 kilogram medicine ball. Participants will throw a medicine ball while standing. The distance of the throw will be measured in centimetres.
Improved Overall Muscle Strength
Time frame: 28 days
Rate of perceived exertion (RPE) using the Borg Scale measuring the difficulty of high-intensity exercise. 1 represents a score of very light activity, and 10 represents a score of maximum effort activity.
Increased Lower Body Muscle Strength in 2/2
Time frame: 28 days
Lower body muscle strength is assessed using the countermovement jump (CMJ) and squat jump (SJ) tests, two validated measures of lower body explosive power. Each participant performs a single jump for each test on a clinically validated open-source jump mat (Chronojump Bocosystems), which records jump height in centimetres. The jump mat uses precise force and time measurements to calculate height, ensuring reliable data output. Participants receive standardised instructions and a demonstration before testing to ensure consistency and accuracy.The highest recorded value is used for analysis.
2 secondary outcomes
Improved Perception of Wellbeing
Time frame: 28 days
Improved Perception of Recovery
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Derived from this study: PubMed 39954269Coope OC, Reales Salguero A, Spurr T, Paez Calvente A, Domenech Farre A, Jordan Fisas E, Lloyd B, Gooderick J, Abad Sangra M, Roman-Vinas B. Effects of Root Extract of Ashwagandha (Withania somnifera) on Perception of Recovery and Muscle Strength in Female Athletes. Eur J Sport Sci. 2025 Mar;25(3):e12265. doi: 10.1002/ejsc.12265.
- Individual participant dataSharing planned: No
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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.
Blanca Roman Viñas principal investigator
Blanquerna, Ramon Llull University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ashwagandha in people with Muscle Strength, run by Blanca Roman-Viñas, MD 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 4 inclusion and 7 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 9 Jan 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?
Yes. Results are posted in the registry (first posted 9 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Increased Lower Body Muscle Strength 1/2 (time frame: 28 days). The study lists 5 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 NCT06264986, which also lists 2 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 9 Jan 2025.