Randomized Clinical Trial to Analyze the Efficacy of Chronic Intake of Different Doses of a β-alanine Supplement on Performance in Recreational Cross-country Road Cyclists
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Power
研究概览
简要总结
Randomized, controlled, double-blind, single-center, controlled clinical trial with three parallel arms depending on the product consumed (experimental product dose 1 and dose 2 and placebo product) to measure the efficacy of 28-day consumption of a sustained-release beta alanine on the physiological efficacy of physical performance in recreational cyclists.
详细描述
Subjects meeting the selection criteria will be randomly assigned to each of the study groups (investigational product dose 1 or dose 2, or placebo, depending on the group to which they have been assigned).
The product to be consumed is beta alanine. Participants will consume the product for 28 days. They will have to take 4 intakes every three hours, the first intake being two hours after waking up.
The study subjects will have to make 2 visits to the laboratory. Physical performance and physiological changes will be evaluated with a 10-minute time trial. The first test will be performed without product consumption and the second after 28 days of consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Male cyclists with more than two years of cycling experience.
- •Perform tests without fatigue.
- •Road bike training at least twice a week.
排除标准
- •Participants with chronic illness.
- •Have a long-term injury that prevents you from training in the previous month.
- •Inability to understand informed consent.
- •Have consumed beta alanine in the three years prior to the start of the study.
- •Consumption of other supplements that may alter performance.
结局指标
主要结局
Power
时间窗: It will be measured on two different occasions. The first day and twenty-eight days later.
Physical performance is measured by direct variables evaluated by the power roller (average power, maximum power, etc.).
Distance covered
时间窗: It will be measured on two different occasions. The first day and twenty-eight days later.
Physical performance is measured by direct variables evaluated by the power roller.
次要结局
- Fatigue(Change of baseline rate of perceived exertion at twenty-eight days)
- Microcapillary blood(It will be measured on two different occasions. Day one and twenty-eight days later.)
- Body weight(The test will be measured at baseline and after 28 days of consumption.)
- Muscle mass(The test will be measured at baseline and after 28 days of consumption.)
- Fat mass(The test will be measured at baseline and after 28 days of consumption.)
- Paresthesia test(It will be measured on two different occasions. on day 1 (before consumption) and twenty-eight days after (after consumption).)
- Lactate(It will be measured on two different occasions. Day one and twenty-eight days later.)
- Heart Rate(It will be measured on two different occasions. Day one and twenty-eight days later.)
- Liver safety variables(It will be measured twice, once at baseline or at the end of the study after 28 days.)
研究者
Francisco Javier López Román
Principal Investigator
Universidad Católica San Antonio de Murcia