NCT04427319已完成不适用
A Randomised Double-blind Clinical Trial to Analyse the Efficacy of Short-term β-Alanine Supplementation in Performance Outcomes of Road Professional Endurance Cyclists
Universidad Católica San Antonio de Murcia2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2020年2月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Fatigue
研究概览
简要总结
A double-blind, placebo-controlled, randomised, with two arms (product and placebo) unicentric clinical trial to analyse the efficacy on physical performance parameters of a product designed for sport during a lapse of two weeks (7 days).
详细描述
After recruitment, subject will be randomised and allocated to one group of the 2 study arms: treatment group or control group (placebo).
A simple randomisation will be performed using software by a random number generator, and assigned to participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Not respecting rest the day before physical tests.
- •Not being in a fasted state (at least 2 h from last meal).
- •Having consumed stimulants acutely before the trial, or under drug treatment affecting perceived effort of the trial.
- •Not being available to perform every trial on the same conditions at the same time of the day.
- •Not sticking to the same diet, 24 h before each trial.
排除标准
- •Adverse event
- •Protocol violation
- •Lost to follow-up
- •Allergy to any of the components of the treatment or placebo product. This includes allergy to β-alanine, wheat, soy, nuts (including peanuts), sesame and its byproducts.
结局指标
主要结局
Fatigue
时间窗: Change of baseline rate of perceived exertion at seven days
Rate of perceived exertion
次要结局
- Paresthesia test(It will be measured on three different occasions. Twice on day 1 (before and after consumption) and seven days after.)
- Microcapillary blood(It will be measured on two different occasions. Day one and seven days later.)
- Performance outcomes(It will be measured on two different occasions. Day one and seven days later.)
研究者
Francisco Javier López Román
Principal Investigator
Universidad Católica San Antonio de Murcia
研究点 (2)
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