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Finalising ethics approval before completing.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ashwagandha root extract | Experimental | 450 mg Ashwagandha root extract |
|
| Placebo | Placebo Comparator | 450 mg corn starch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Root extract Ashwagandha | Dietary Supplement | 450 mg Ashwagandha root extract |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Salivary Cortisol Concentration from Baseline to 6 Weeks | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Salivary Alpha Amylase from Baseline to 6 Weeks | 6 weeks | |
| Change in Handgrip Strength (kg) from Baseline to 6 Weeks | Hand grip strength using CAMRY dynamometer | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivia C Coope, PhD | Blanquerna Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Strength and Nutrition Ltd | Brighton | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33670194 | Background | 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. | |
| 22131739 | Background | 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. |
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De-identified individual participant data related to primary and secondary outcomes will be shared with other sports nutrition researchers upon reasonable request. Data sharing will be subject to ethical approval, data protection requirements, and safeguarding considerations, and will exclude any information that could identify participants.
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Randomised, double-blind and placebo-controlled clinical trial
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| Corn Starch |
| Other |
450 mg corn starch |
|
| Change in Countermovement Jump Height (cm) from Baseline to 6 Weeks | 6 weeks |
| Change in 1 km Time Trial Completion Time (seconds) from Baseline to 6 Weeks | Maximal effort run of 1km | 6 weeks |
| Perception of sleep quality | 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 | 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 | 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 | 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 | 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 |
| 19077317 | Background | 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. |
| ID | Term |
|---|---|
| D013213 | Starch |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |
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