Randomized Clinical Trial to Analyze the Safety of Chronic Intake of a β-alanine Supplement in Active Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Liver safety variables
研究概览
简要总结
Single-center, double-blind, placebo-controlled clinical trial with two arms (product and placebo) to analyze the safety of beta-alanine consumption in active people.
详细描述
After recruitment, subjects will be randomized and assigned to one of the two arms of the study: beta-alanine group or control group (placebo).
Subjects must be active people, and will take a dose of 15 g per day of the product for 4 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men between 18 and 40 years of age.
- •Physically active people. They must train at least 3 sessions per week.
- •Have been training continuously for at least one year.
排除标准
- •Participant suffering from chronic illness.
- •Serious or terminal illness.
- •Suffering from a lasting injury that prevents him/her from training in the month prior to the intervention.
- •Inability to understand the informed consent.
- •Previous experience in the consumption of beta alanine.
结局指标
主要结局
Liver safety variables
时间窗: Change in hepatic safety after 8 weeks of consumption
It is a blood test that measures the presence of some enzymes, proteins and bilirubin in the blood, with the aim of determining if there is any alteration in the liver. Enzyme GPT, GOT, Gamma GT, LDH, alkaline phosphatase and bilirubin (UI/L)
次要结局
- Paresthesia test(Change after 8 weeks of consumption)
研究者
Francisco Javier López Román
Principal Investigator
Universidad Católica San Antonio de Murcia