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The Effects of Ashwagandha (Withania Somnifera) Supplementation on Exercise Performance in Female Footballers

The Effects of Ashwagandha (Withania Somnifera) Supplementation on Exercise Performance in Female Footballers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06264986
Enrollment
30
Registered
2024-02-20
Start date
2024-01-13
Completion date
2024-04-27
Last updated
2025-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Strength

Brief 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? 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.

Interventions

DIETARY_SUPPLEMENTAshwagandha

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.

OTHERPlacebo

600mg chickpea flour in a hydroxypropyl methylcellulose capsule, once a day for 28 days

Sponsors

Blanca Roman-Viñas, MD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Intervention model description

Double-blind, placebo-controlled, randomised trial

Eligibility

Sex/Gender
FEMALE
Age
17 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Female * Playing football professionally * At a sub-elite to elite standard * Healthy and free of disease

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Increased Maximum Voluntary Muscle Strength28 daysHand grip strength. This will be measured with a CAMRY digital hand dynamometer and the unit of measurement will be kilograms.
Improved Overall Muscle Strength28 daysRate 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 2/228 daysLower 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.
Increased Lower Body Muscle Strength 1/228 daysJump 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 Upper Body Muscle Strength and Explosiveness28 daysMedicine 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.

Secondary

MeasureTime frameDescription
Improved Perception of Recovery28 daysTotal 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.
Improved Perception of Wellbeing28 daysHooper 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).

Countries

Spain

Participant flow

Participants by arm

ArmCount
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.
15
Placebo
600mg Gluten-free chickpea powder, hydroxypropyl methylcellulose capsule Placebo: 600mg chickpea flour in a hydroxypropyl methylcellulose capsule, once a day for 28 days
15
Total30

Baseline characteristics

CharacteristicKSM-66PlaceboTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
15 Participants15 Participants30 Participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Spain
15 participants15 participants30 participants
Sex/Gender, Customized
Female
15 Participants15 Participants30 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 150 / 15
other
Total, other adverse events
0 / 150 / 15
serious
Total, serious adverse events
0 / 150 / 15

Outcome results

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.

Time frame: 28 days

ArmMeasureValue (MEAN)Dispersion
KSM-66Improved Overall Muscle Strength6.1 Units on a scaleStandard Deviation 0.3
PlaceboImproved Overall Muscle Strength5.4 Units on a scaleStandard Deviation 0.5
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.

Time frame: 28 days

ArmMeasureValue (MEAN)Dispersion
KSM-66Increased Lower Body Muscle Strength 1/22410.0 WattsStandard Deviation 82.5
PlaceboIncreased Lower Body Muscle Strength 1/22492.5 WattsStandard Deviation 96.6
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.

Time frame: 28 days

ArmMeasureValue (MEAN)Dispersion
KSM-66Increased Lower Body Muscle Strength in 2/227.9 CentimetresStandard Deviation 1
PlaceboIncreased Lower Body Muscle Strength in 2/228.7 CentimetresStandard Deviation 1.5
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.

Time frame: 28 days

ArmMeasureValue (MEAN)Dispersion
KSM-66Increased Maximum Voluntary Muscle Strength33.14 kilogramsStandard Deviation 1.5
PlaceboIncreased Maximum Voluntary Muscle Strength31.8 kilogramsStandard Deviation 1
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.

Time frame: 28 days

ArmMeasureValue (MEAN)Dispersion
KSM-66Increased Upper Body Muscle Strength and Explosiveness160.7 CentimetresStandard Deviation 8.4
PlaceboIncreased Upper Body Muscle Strength and Explosiveness153.9 CentimetresStandard Deviation 7.9
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.

Time frame: 28 days

ArmMeasureValue (MEAN)Dispersion
KSM-66Improved Perception of Recovery15.9 Units on a scaleStandard Deviation 0.6
PlaceboImproved Perception of Recovery14.0 Units on a scaleStandard Deviation 0.6
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).

Time frame: 28 days

ArmMeasureValue (MEAN)Dispersion
KSM-66Improved Perception of Wellbeing11.4 Units on a scaleStandard Deviation 1.2
PlaceboImproved Perception of Wellbeing13.5 Units on a scaleStandard Deviation 1.3

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026