A Randomized Placebo-controlled Trial Investigating the Effects of Riboflavin in Mitigating Muscle Soreness in Ultra-marathon Athletes
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Muscle soreness measure for long stage of the ultramarathon
研究概览
简要总结
The aim of this project is to investigate the effects of riboflavin, also known as vitamin B2, on preventing delayed onset muscle soreness (DOMS) in ultramarathon athletes through a randomized placebo-controlled study.
详细描述
The riboflavin 100 mg capsules will be self-dosed by the participant, one capsule prior to the long stage of the race followed by a second dose at the end of the long stage. Historically, long-stage finish times have ranged between 8 and 24 hours. The placebo will also be dosed as one capsule on the morning of the long stage, prior to the race start, and one capsule at the end of the long stage.
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
- Single (Participant)
盲法说明
Subjects will be masked to which intervention they receive, active study drug or placebo.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 18 or over
- •In good general health as evidenced by readiness to participate in an ultramarathon
- •Ability to take oral medication and be willing to adhere to the study regimen
- •For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening.
排除标准
- •Unable to read or understand English
- •Under 18 years of age
- •Pregnancy or lactation
- •Known allergic reactions to components of the investigational drugs
研究组 & 干预措施
Riboflavin Group
Riboflavin 100mg will be self administered by participants, one capsules prior to the long stage of the race followed by a second dose at the completion of the long stage.
干预措施: Riboflavin (Drug)
Placebo/Control Group
Placebo will be self administered by participants, one capsule prior to the long stage of the race followed by a second dose at the completion of the long stage.
干预措施: Placebo (Drug)
结局指标
主要结局
Muscle soreness measure for long stage of the ultramarathon
时间窗: Baseline to 6 days
Change in muscle soreness at completion of the long stage (80+ kilometers) of the ultramarathon. Muscle soreness the day following long stage completion. Muscle soreness will be measured using a Likert scale rated from 0 to 10 where 0 indicates no soreness and 10 indicates unbearable pain.
次要结局
- Muscle soreness measure post-race(Day 7)
研究者
Steven Moore
Associate Professor
The University of Texas Health Science Center at San Antonio