NCT03032445已完成不适用
Potential Impacts of Beer on Post-Race Ultramarathon Athletes
State University of New York - Upstate Medical University1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2017年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Changes in sodium level pre and post intervention
研究概览
简要总结
Athletes who are participating in the Keys100 Ultramarathon event in Key West, FL are eligible, based on inclusion criteria, to participate in this research study that is seeking to determine whether supplementation of beer (alcohol) immediately following a long distance ultramarathon race can positively impact exercise-associated hyponatremia [EAH].
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Completed informed consent
- •Ability to read and speak English language
- •Age 21 years or older
- •Not considered a vulnerable population, such as pregnant (by history) or cognitively impaired.
- •Able to tolerate needle exposure for blood draw
- •Willing to drink alcoholic or nonalcoholic beer
- •Willing not to eat or drink other than the study fluid during 1 hour study period
- •Participating in 100 mile or 50 mile race
- •To participate in the controlled part of the study the individual must have fully completed either the 100 mile or the 50 mile race.
排除标准
- •Under age 21 years
- •Vulnerable population, such as pregnant (by history) or cognitively impaired
- •Subjects who are alcohol-naive (i.e first exposure to alcohol)
- •Subjects with known familial and/or genetic backgrounds at higher risk for the development of alcohol dependence
- •Subjects should not be seeking treatment for alcohol or drug abuse
- •Subjects who are in general high risk for abuse such as those completing or participating in alcohol or drug abuse programs
- •Subjects who have had a sustained period of abstinence, with history of heavy drinking problems, while living in the community
研究组 & 干预措施
Alcoholic beer
Experimental
At least 6% alcohol content
干预措施: Alcoholic Beer (Other)
Non alcoholic beer
Placebo Comparator
Less than 0.5% alcohol content
干预措施: Non alcoholic beer (Other)
结局指标
主要结局
Changes in sodium level pre and post intervention
时间窗: One hour
次要结局
- Number of participants with abnormal laboratory values(One hour)
- Level of cognition(Within one month of intervention)
- Measurement of urine output(One hour)
研究者
Jeremy Joslin, MD
Associate Professor
State University of New York - Upstate Medical University
研究点 (1)
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