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

Muscle Strength Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06264986
• Other study ID #: 2023-09-02
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 13, 2024
• Est. completion date: February 21, 2024

Study information

• Verified date: February 2024
• Source: University Ramon Llull
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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? 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: February 21, 2024
• Est. primary completion date: February 21, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 17 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Strength

Intervention

Dietary Supplement:
• 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.

Other:
• Placebo
600mg chickpea flour in a hydroxypropyl methylcellulose capsule, once a day for 28 days

Locations

Country	Name	City	State
Spain	Club Esportiu Seagull	Badalona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Blanca Roman-Viñas, MD

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increased lower body muscle strength	Jump strength, demonstrated by counter movement jump and squat jump. The unit of measurement will be in centimetres.	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.	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 inches.	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.	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.	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.	28 days