Trial Outcomes & Findings for The Effects of Ashwagandha (Withania Somnifera) Supplementation on Exercise Performance in Female Footballers (NCT NCT06264986)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

28 days

Results posted on

2025-01-09

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Placebo 600mg Gluten-free chickpea powder, hydroxypropyl methylcellulose capsule Placebo: 600mg chickpea flour in a hydroxypropyl methylcellulose capsule, once a day for 28 days
Overall Study STARTED	15	15
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	15	15

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	KSM-66 n=15 Participants 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.	Placebo n=15 Participants 600mg Gluten-free chickpea powder, hydroxypropyl methylcellulose capsule Placebo: 600mg chickpea flour in a hydroxypropyl methylcellulose capsule, once a day for 28 days	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=15 Participants	15 Participants n=15 Participants	30 Participants n=30 Participants
Age, Categorical >=65 years	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=30 Participants
Sex/Gender, Customized Female	15 Participants n=15 Participants	15 Participants n=15 Participants	30 Participants n=30 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Spain	15 participants n=15 Participants	15 participants n=15 Participants	30 participants n=30 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	KSM-66 n=15 Participants 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.	Placebo n=15 Participants 600mg Gluten-free chickpea powder, hydroxypropyl methylcellulose capsule Placebo: 600mg chickpea flour in a hydroxypropyl methylcellulose capsule, once a day for 28 days
Increased Lower Body Muscle Strength 1/2	2410.0 Watts Standard Deviation 82.5	2492.5 Watts Standard Deviation 96.6

PRIMARY outcome

Timeframe: 28 days

Hand grip strength. This will be measured with a CAMRY digital hand dynamometer and the unit of measurement will be kilograms.

Outcome measures

Outcome measures
Measure	KSM-66 n=15 Participants 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.	Placebo n=15 Participants 600mg Gluten-free chickpea powder, hydroxypropyl methylcellulose capsule Placebo: 600mg chickpea flour in a hydroxypropyl methylcellulose capsule, once a day for 28 days
Increased Maximum Voluntary Muscle Strength	33.14 kilograms Standard Deviation 1.5	31.8 kilograms Standard Deviation 1.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	KSM-66 n=15 Participants 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.	Placebo n=15 Participants 600mg Gluten-free chickpea powder, hydroxypropyl methylcellulose capsule Placebo: 600mg chickpea flour in a hydroxypropyl methylcellulose capsule, once a day for 28 days
Increased Upper Body Muscle Strength and Explosiveness	160.7 Centimetres Standard Deviation 8.4	153.9 Centimetres Standard Deviation 7.9

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	KSM-66 n=15 Participants 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.	Placebo n=15 Participants 600mg Gluten-free chickpea powder, hydroxypropyl methylcellulose capsule Placebo: 600mg chickpea flour in a hydroxypropyl methylcellulose capsule, once a day for 28 days
Improved Overall Muscle Strength	6.1 Units on a scale Standard Deviation 0.3	5.4 Units on a scale Standard Deviation 0.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	KSM-66 n=15 Participants 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.	Placebo n=15 Participants 600mg Gluten-free chickpea powder, hydroxypropyl methylcellulose capsule Placebo: 600mg chickpea flour in a hydroxypropyl methylcellulose capsule, once a day for 28 days
Increased Lower Body Muscle Strength in 2/2	27.9 Centimetres Standard Deviation 1.0	28.7 Centimetres Standard Deviation 1.5

SECONDARY outcome

Timeframe: 28 days

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).

Outcome measures

Outcome measures
Measure	KSM-66 n=15 Participants 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.	Placebo n=15 Participants 600mg Gluten-free chickpea powder, hydroxypropyl methylcellulose capsule Placebo: 600mg chickpea flour in a hydroxypropyl methylcellulose capsule, once a day for 28 days
Improved Perception of Wellbeing	11.4 Units on a scale Standard Deviation 1.2	13.5 Units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: 28 days

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.

Outcome measures

Outcome measures
Measure	KSM-66 n=15 Participants 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.	Placebo n=15 Participants 600mg Gluten-free chickpea powder, hydroxypropyl methylcellulose capsule Placebo: 600mg chickpea flour in a hydroxypropyl methylcellulose capsule, once a day for 28 days
Improved Perception of Recovery	15.9 Units on a scale Standard Deviation 0.6	14.0 Units on a scale Standard Deviation 0.6

Adverse Events

KSM-66

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Olivia Coope

Blanquerna Institute - Universitat Ramon Llull

Phone: +447882461097

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place