- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07343219
Effects of Root Extract Ashwagandha (KSM-66) on Physiological Stress, Perception of Recovery and Muscle Strength in Youth Footballers
This trial examines if six weeks of taking 450 mg Ashwagandha root extract affects exercise performance and recovery in youth male elite football players.
Ashwagandha root extract is increasingly used by athletes, but controlled research in adolescent athletes is limited and the majority of evidence is in an adult population. This study will assess short-term responses in youth players.
Participants will be randomly assigned to take either Ashwagandha root extract or a placebo once daily for six weeks. Players will complete training-based tests, provide saliva samples and complete a short, validated questionnaire on perception of wellness. Any adverse events will be documented and reported.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The objective of this trial is to learn whether a short period of taking 450mg of Ashwagandha root extract affects performance, recovery, muscle strength and wellbeing in youth male elite football players.
The researchers are studying Ashwagandha root extract as it is increasingly used by athletes and the general population of varying ages for well-being, performance and recovery purposes, despite a lack of controlled research examining its effects in adolescent athletes. Most existing evidence comes from adult populations, and it remains unclear whether similar physiological and perceptual responses occur in adolescents engaged in structured training.
The main questions the study aims to answer are:
Does taking Ashwagandha root extract change stress levels measured through saliva in youth elite footballers?
Does it affect muscle strength, recovery, sleep, or muscle soreness?
Participants will be randomly assigned to take either Ashwagandha root extract or a placebo once a day for six weeks. During the study, players will complete strength and fitness tests during usual training time, then provide saliva samples afterwards. Short questionnaires will be solicited the day after about how they feel. Any adverse events that occur during the study will be documented and reported.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Brighton, United Kingdom
- Strength and Nutrition Ltd
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male youth football player
- Classified as 'healthy' and 'free of disease'
- Actively training with the selected football academy
Exclusion Criteria:
- Lack of signed consent form
- No active use of medication
- No active use of ergogenic aids
- Allergies to nightshades
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ashwagandha root extract
450 mg Ashwagandha root extract
|
450 mg Ashwagandha root extract
|
|
Placebo Comparator: Placebo
450 mg corn starch
|
450 mg corn starch
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in Salivary Cortisol Concentration from Baseline to 6 Weeks
Time Frame: 6 weeks
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Salivary Alpha Amylase from Baseline to 6 Weeks
Time Frame: 6 weeks
|
6 weeks
|
|
|
Change in Handgrip Strength (kg) from Baseline to 6 Weeks
Time Frame: 6 weeks
|
Hand grip strength using CAMRY dynamometer
|
6 weeks
|
|
Change in Countermovement Jump Height (cm) from Baseline to 6 Weeks
Time Frame: 6 weeks
|
6 weeks
|
|
|
Change in 1 km Time Trial Completion Time (seconds) from Baseline to 6 Weeks
Time Frame: 6 weeks
|
Maximal effort run of 1km
|
6 weeks
|
|
Perception of sleep quality
Time Frame: Baseline to 6 weeks
|
Sleep quality will be assessed using the sleep domain of the Hooper Index, which is one of four domains within the questionnaire (fatigue, stress, delayed onset muscle soreness, and sleep).
The sleep item is rated on a 10-point scale (1 to 10), where 1 indicates very, very good sleep and 10 indicates very, very poor sleep.
This domain will be analysed independently as a subset of the Hooper Index, rather than as part of the total score.
|
Baseline to 6 weeks
|
|
Perception of stress
Time Frame: Baseline to 6 weeks
|
Perceived stress will be assessed using the sleep domain of the Hooper Index, which is one of four domains within the questionnaire (fatigue, stress, delayed onset muscle soreness and sleep).
The stress item is rated on a 10-point scale (1 to 10), where 1 indicates very, very good and 10 indicates very, very poor.
This domain will be analysed independently as a subset of the Hooper Index, rather than as part of the total score.
|
Baseline to 6 weeks
|
|
Perception of muscle soreness
Time Frame: Baseline to 6 weeks
|
Perceived muscle soreness will be assessed using the sleep domain of the Hooper Index, which is one of four domains within the questionnaire (fatigue, stress, delayed onset muscle soreness and sleep).
The muscle soreness item is rated on a 10-point scale (1 to 10), where 1 indicates very, very good and 10 indicates very, very poor.
This domain will be analysed independently as a subset of the Hooper Index, rather than as part of the total score.
|
Baseline to 6 weeks
|
|
Perception of fatigue
Time Frame: Baseline to 6 weeks
|
Perceived fatigue will be assessed using the sleep domain of the Hooper Index, which is one of four domains within the questionnaire (fatigue, stress, delayed onset muscle soreness and sleep).
The fatigue item is rated on a 10-point scale (1 to 10), where 1 indicates very, very good and 10 indicates very, very poor.
This domain will be analysed independently as a subset of the Hooper Index, rather than as part of the total score.
|
Baseline to 6 weeks
|
|
Overall Hooper Index Score
Time Frame: Baseline to 6 weeks
|
Perceived recovery will be assessed using the Hooper Index, which evaluates four domains: fatigue, stress, delayed onset muscle soreness (DOMS) and sleep quality.
Each domain is rated on a 10-point scale (1 to 10), where 1 indicates very, very good and 10 indicates very, very poor.
The total Hooper Index score is calculated by summing the four domains, resulting in a possible range of 4 to 40, with higher scores indicating worse perceived recovery, greater fatigue and stress, and lower scores indicating better recovery.
|
Baseline to 6 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Olivia C Coope, PhD, Blanquerna Institute
Publications and helpful links
General Publications
- 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.
- Mishra RK, Trivedi R, Pandya MA. A clinical study of Ashwagandha ghrita and Ashwagandha granules for its Brumhana and Balya effect. Ayu. 2010 Jul;31(3):355-60. doi: 10.4103/0974-8520.77164.
- Petroczi A, Naughton DP, Pearce G, Bailey R, Bloodworth A, McNamee M. Nutritional supplement use by elite young UK athletes: fallacies of advice regarding efficacy. J Int Soc Sports Nutr. 2008 Dec 15;5:22. doi: 10.1186/1550-2783-5-22.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20251103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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