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

NCT06264986 | Completed Results

• 1 other identifier: 2023-09-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Strength

Outcome Measures

Primary Outcomes (5)

• 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.

  28 days

Secondary Outcomes (2)

• Improved Perception of Wellbeing

  28 days

• Improved Perception of Recovery

  28 days

Study Arms (2)

KSM-66

EXPERIMENTAL

600mg (5% withanolides) KSM-66 ashwagandha, hydroxypropyl methylcellulose capsule

Dietary Supplement: Ashwagandha

Placebo

PLACEBO COMPARATOR

600mg Gluten-free chickpea powder, hydroxypropyl methylcellulose capsule

Other: Placebo

Interventions

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.

Also known as: KSM-66, Root extract ashwagandha

KSM-66

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 17 Years - 40 Years
• Gender Eligibility Details: Participants must be female or assigned female at birth
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Blanca Roman-Viñas, MD: lead

Study Sites (1)

Club Esportiu Seagull

Badalona, Barcelona, 08917, Spain

Location

Related Publications (2)

• 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.

  PMID: 33670194 BACKGROUND

• 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.

  PMID: 39954269 DERIVED

MeSH Terms

Interventions

Ashwagandha

Limitations and Caveats

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.

Results Point of Contact

• Title: Olivia Coope
• Organization: Blanquerna Institute - Universitat Ramon Llull

oliviacharlottec@blanquerna.url.edu

+447882461097

Study Officials

• Blanca Roman Viñas

  Blanquerna, Ramon Llull University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Double-blind, placebo-controlled, randomised trial

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 20, 2024
• Study Start: January 13, 2024
• Primary Completion: February 21, 2024
• Study Completion: April 27, 2024
• Last Updated: January 9, 2025
• Results First Posted: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)