The Effects of Sleep on Human Microbiota: Implications for Health and Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Changes in human microbiota induced by sleep manipulation in healthy subjects
研究概览
简要总结
The aggregate of microorganisms inhabiting the human body can be regarded as a dynamic reflector of both healthy and disease states, altering in response to changes in the environment. This may precede clinically detectable disease; and thereby, could be used to predict disease onset and additionally monitor response to treatment and predict prognosis. The primary hypothesis of this pilot study is that the human microbial communities are influenced by sleep and altered in humans with abnormal sleep patterns, and they may ultimately relate to disease risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
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
- •Only subjects who are eligible for ongoing IRB-approved studies will be deemed eligible for this protocol.
排除标准
- •Pregnant or breast-feeding women
- •Subjects who are ineligible for ongoing IRB-approved studies will not be included in this protocol
研究组 & 干预措施
weight gain
Weight gain
干预措施: Weight gain (Dietary Supplement)
sleep restriction
Sleep restriction
干预措施: Sleep restriction (Behavioral)
normal sleep
Normal sleep
结局指标
主要结局
Changes in human microbiota induced by sleep manipulation in healthy subjects
时间窗: 1 year
Changes in human microbiota induced by fluctuations in body weight and sleep in healthy subjects
时间窗: 20 weeks
次要结局
未报告次要终点