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

Not Applicable

Completed

Conditions: Muscle Strength

Interventions: Dietary Supplement: Ashwagandha
Other: Placebo

Registration Number: NCT06264986

Lead Sponsor: Blanca Roman-Viñas, MD

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 30

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KSM-66	Ashwagandha	600mg (5% withanolides) KSM-66 ashwagandha, hydroxypropyl methylcellulose capsule
Placebo	Placebo	600mg Gluten-free chickpea powder, hydroxypropyl methylcellulose capsule

Primary Outcome Measures

Name	Time	Method
Increased Lower Body Muscle Strength 1/2	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	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	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Improved Perception of Wellbeing	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).
Improved Perception of Recovery	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.