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临床试验/NCT03596307
NCT03596307Unknown不适用

The Effects of Ashwagandha In Endurance Exercise Performance

Arjuna Natural Limited2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2018年8月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
12
试验地点
2
主要终点
Performance (mean power output (Watt))

研究概览

简要总结

Ashwagandha (Withania Somnifera) is a widely used herb in Ayurvedic medicine for vitality and rejuvenation. This study investigates the effects of both acute and short-term oral supplementation of Shoden (Ashwagandha extract) intake on performance and rate of perceived exertion in high-intensity aerobic and anaerobic exercise.

详细描述

Only a few clinical trials have looked at the effects of Ashwagandha in exercise and training. The studies had a dosage of 2 x 300 mg & 2 x 500 mg per day for 8 weeks and found to stimulate effects of strength training on muscle strength and muscle mass (Wankhede et al., 2015) and small increments in time to exhaustion and VO2max (Shenoy et al., 2012). However, the training intervention in both the studies were not adequately controlled and did not make a distinction between the acute and short-term effects of Ashwagandha intake.

Moreover, a lot of herbal supplements are commercially available containing majority of alkaloids and small amount of withaferine. European Food Safety Authority (EFSA) has categorized anaferine, anahygrine, withanine, sominiferine, somnine, tropine etc as toxic and harmful. Apart from alkaloids, withaferine A has also been categorized as cytotoxic lactones by EFSA. The Ashwagandha extract developed by Arjuna Natural Ltd is free from these alkaloids and is standardized to contain about 35% glycowithanolides.

This study will be a randomized, double blinded, placebo controlled, two treatment, crossover study and will be conducted in 2 phases ( acute & short term) with a total of 5 identical test sessions. Each test session involves a maximal incremental cycling test followed by a 90-sec maximal cycling performance test (day 1), and a 30-min simulated time-triaI on a cycling ergometer (day 2). Day 1 and day 2 are separated by a 24hr rest interval and for each subject it will be consistently scheduled on the same time of the day in order to eliminate a potential impact of diurnal variation in the results.

研究设计

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

盲法说明

Double blinded

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Males between 18 and 35 years old
  • Physically fit and involved in physical fitness training, or in individual or team sport activity for 2-4hours per week, or 3-6 hours per week for cycling
  • Body mass index between 18 and 25
  • Good health status confirmed by a medical screening

排除标准

  • Any kind of injury/pathology that is a contra-indication to perform high-intensity exercise.
  • Intake of any medication or nutritional supplement that is proven to affect exercise performance
  • Intake of analgetics, anti-oxidants, or anti-inflammatory agents from 2 weeks prior to the start of the study
  • More than 3 alcoholic beverages per day, including a maximum of one glass of wine per day
  • Blood donation within 3 months prior to the start of the study
  • Involvement in elite athletic training at a semi-professional or professional level
  • Current participation in another research trial
  • Any other argument to believe that the subject is unlikely to successfully complete the full study protocol

研究组 & 干预措施

Ashwagandha extract

Experimental

180 mg Shoden once daily before breakfast for 2 days in Acute Phase and 16 days in Short Term Phase.

干预措施: Ashwagandha extract (Dietary Supplement)

Ashwagandha extract

Experimental

180 mg Shoden once daily before breakfast for 2 days in Acute Phase and 16 days in Short Term Phase.

干预措施: Placebo (Dietary Supplement)

Placebo

Placebo Comparator

180 mg identical placebo once daily before breakfast for 2 days in Acute Phase and 16 days in Short Term Phase.

干预措施: Ashwagandha extract (Dietary Supplement)

Placebo

Placebo Comparator

180 mg identical placebo once daily before breakfast for 2 days in Acute Phase and 16 days in Short Term Phase.

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

Performance (mean power output (Watt))

时间窗: 30-min simulated time trials

Simulated time trial on cycling ergometer (Avantronic Cyclus2)

次要结局

  • Oxygen Intake (VO2Max)(Measured during Incremental, 90s, and 30 min time trial.)
  • Capillary Lactate(Incremental VO2 max test - middle and at the end of each incremental step ; 90s VO2 max test - just before the start of the test and 4 min following exhaustion; 30-Min Time Trial - 5-min intervals)
  • Rate of perceived exertion(At the end of incremental VO2 max test ; halfway (15 min) and at the end (30 min) of the 30 min time trial; on cycling ergometer)

研究者

发起方
Arjuna Natural Limited
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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