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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KSM-66 | Experimental | 600mg (5% withanolides) KSM-66 ashwagandha, hydroxypropyl methylcellulose capsule |
|
| Placebo | Placebo Comparator | 600mg Gluten-free chickpea powder, hydroxypropyl methylcellulose capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ashwagandha | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
Participants must be female or assigned female at birth
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| Name | Affiliation | Role |
|---|---|---|
| Blanca Roman Viñas | Blanquerna, Ramon Llull University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Club Esportiu Seagull | Badalona | Barcelona | 08917 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33670194 | Background | 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. | |
| 39954269 | Derived | Coope 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | KSM-66 | 600mg (5% withanolides) KSM-66 ashwagandha, hydroxypropyl methylcellulose capsule 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. |
| FG001 | Placebo | 600mg Gluten-free chickpea powder, hydroxypropyl methylcellulose capsule Placebo: 600mg chickpea flour in a hydroxypropyl methylcellulose capsule, once a day for 28 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Female, healthy, over 18 years of age, footballer assigned to a professional club.
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| ID | Title | Description |
|---|---|---|
| BG000 | KSM-66 | 600mg (5% withanolides) KSM-66 ashwagandha, hydroxypropyl methylcellulose capsule 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. 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. | Posted | Mean | Standard Deviation | Watts | 28 days |
|
One month
Adverse events were defined in accordance with ClinicalTrials.gov standards including any medical occurrences regardless of relation to the intervention. Serious adverse events included any events resulting in death, life-threatening situations, hospitalisation or significant disability. Data were collected over one month, with monitoring conducted weekly based on participant self-reports and investigator assessments. No differences in definition were applied from the standard ClinicalTrials.gov
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | KSM-66 | 600mg (5% withanolides) KSM-66 ashwagandha, hydroxypropyl methylcellulose capsule 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. |
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No clinical testing, such as blood biomarkers, to correlate physiological data with observed outcomes, limiting conclusions about ashwagandha's biochemical effects on muscle strength and recovery. Sleep quality was self-reported - future studies should use objective methods. The convenience sample limits generalisability, and larger samples are needed. Lack of a crossover design also restricts control over confounders, and future research could benefit from this approach to reduce variability.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Olivia Coope | Blanquerna Institute - Universitat Ramon Llull | +447882461097 | oliviacharlottec@blanquerna.url.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2024 | Jan 3, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 1, 2024 | Jan 3, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| C030693 | Ashwagandha |
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Double-blind, placebo-controlled, randomised trial
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|
|
| Placebo | Other | 600mg chickpea flour in a hydroxypropyl methylcellulose capsule, once a day for 28 days |
|
| 28 days |
| 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. | 28 days |
| BG001 | Placebo | 600mg Gluten-free chickpea powder, hydroxypropyl methylcellulose capsule Placebo: 600mg chickpea flour in a hydroxypropyl methylcellulose capsule, once a day for 28 days |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | 600mg Gluten-free chickpea powder, hydroxypropyl methylcellulose capsule Placebo: 600mg chickpea flour in a hydroxypropyl methylcellulose capsule, once a day for 28 days |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | kilograms | 28 days |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Centimetres | 28 days |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Units on a scale | 28 days |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | Units on a scale | 28 days |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Units on a scale | 28 days |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | Centimetres | 28 days |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Placebo | 600mg Gluten-free chickpea powder, hydroxypropyl methylcellulose capsule Placebo: 600mg chickpea flour in a hydroxypropyl methylcellulose capsule, once a day for 28 days | 0 | 15 | 0 | 15 | 0 | 15 |
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