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临床试验/NCT07041853
NCT07041853已完成不适用

The Effects of KSM-66 Ashwagandha (Withania Somnifera) Supplementation on Recovery and Muscle Strength in Academy Athletes

University Ramon Llull1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2025年6月12日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
56
试验地点
1
主要终点
Cortisol

研究概览

简要总结

This double-blind, randomised, placebo-controlled trial will examine the effects of 42-day root extract ashwagandha (KSM-66) supplementation on recovery and muscle strength in male and female rugby and water polo players. Participants will receive either 600 mg of ashwagandha or a placebo daily. Outcomes include hormonal stress markers, perceived exertion, wellness, muscle soreness and strength and performance metrics (grip strength, jump tests, 1RM lifts, Bronco test).

详细描述

This double-blind, randomised, placebo-controlled trial aims to investigate the effects of ashwagandha (ASH) supplementation on recovery and muscle strength in male and female rugby and water polo players. Participants will supplement either KSM-66 ashwagandha (600 mg, standardised to 5% withanolides) or a placebo once daily for 42 days. The study will evaluate outcomes related to hormonal stress markers, perceived exertion, wellness, muscle soreness, and physical performance.

Primary biomarkers include cortisol, DHEA-S, testosterone, melatonin, alpha-amylase, and cortisone, assessed through saliva samples. Subjective measures will include the Borg Rate of Perceived Exertion Scale and the Hooper Index for sleep quality, stress, fatigue, and delayed onset muscle soreness (DOMS). Physical performance will be assessed using grip strength (CAMRY dynamometer), vertical jump tests (countermovement jump, squat jump), broad jump, 1-repetition maximum (1RM) tests for deadlift, bench press, and pull-up, as well as the Bronco test. Supplement satisfaction will be evaluated via questionnaire.

Participants' dietary intake will be recorded using a self-tracking method (Snap-N-Send) and analysed using Nutritics software; food diaries will serve as covariates in the final analysis. The study will be conducted in partnership with CN Poble Nou, a professional sports club in Barcelona, Spain.

Ashwagandha use is increasingly common among athletes despite limited evidence on appropriate dosing and performance outcomes. This study will contribute to scientific understanding of its potential short-term benefits, particularly in high-contact sports where managing cortisol and recovery is critical.

All participants will provide informed consent, and ethical considerations focus on safety, data privacy, and the right to withdraw from the study at any time.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Above the age of 18
  • Healthy and free of disease
  • Assigned as an athlete at CN Poble Nou sports academy

排除标准

  • Allergies to nightshades such as tomato, aubergine, potatoes and peppers
  • Active supplementation with other ergogenic aids (to not interfere with existing treatment)
  • Medication or contraceptives (to not interfere with existing treatment)
  • Liver conditions (to not interfere with existing treatment)
  • Thyroid conditions (to not interfere with existing treatment)
  • Diabetes or certain autoimmune conditions (to not interfere with existing treatment)
  • Active pregnancy (to not interfere with existing treatment)
  • No signing of the consent form

结局指标

主要结局

Cortisol

时间窗: Baseline and final measurement at 6 weeks

Salivary cortisol

Hand grip

时间窗: Baseline and final measurement at 6 weeks

Hand grip strength in kilograms, CAMRY dynanometer

次要结局

  • Cortisone(Baseline and final measurement at 6 weeks)
  • Testosterone(Baseline and final measurement at 6 weeks)
  • Melatonin(Baseline and final measurement at 6 weeks)
  • DHEA-s(Baseline and final measurement at 6 weeks)
  • Alpha-amylase(Baseline and final measurement at 6 weeks)
  • Bronco test(Baseline and final measurement at 6 weeks)

研究者

发起方
University Ramon Llull
申办方类型
Other
责任方
Principal Investigator
主要研究者

Blanca Roman-Viñas, MD

Professor

University Ramon Llull

研究点 (1)

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