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

NCT ID: NCT06264986

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-13
• Study Completion Date: 2024-04-27

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.

Conditions

Muscle Strength

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

KSM-66

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

Group Type: EXPERIMENTAL

Ashwagandha

Intervention Type: 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.

Placebo

600mg Gluten-free chickpea powder, hydroxypropyl methylcellulose capsule

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: OTHER

Other Intervention Names

KSM-66; Root extract ashwagandha

Eligibility Criteria

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

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Blanca Roman-Viñas, MD

OTHER

Sponsor Role: lead

Responsible Party

Blanca Roman-Viñas, MD

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Blanca Roman Viñas

Role: PRINCIPAL_INVESTIGATOR

Blanquerna, Ramon Llull University

Locations

Club Esportiu Seagull

Badalona, Barcelona, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 33670194 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39954269 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2023-09-02

Identifier Type: -

Identifier Source: org_study_id