Influence of Diet on Sleep and Cardiovascular Risk
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Score on the Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
The goal of this study is to test the impact of diet on sleep and cardiovascular disease risk factors.
详细描述
Poor sleep quality is highly prevalent in adults in the U.S. and worldwide. Recent work suggests that dietary intakes may influence sleep. This mechanistic study will test whether consuming a healthy, Mediterranean diet will improve sleep quality in U.S. adults with poor sleep and lead to better cardiovascular disease risk profile. Given the relationship between sleep and cardiovascular health, improving sleep quality through dietary measures could contribute to improving health in adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Statistician and research technicians involved in data and sample analyses will be blind to intervention.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sleep >6 hours/night
- •Sleep complaints
排除标准
- •Allergies to foods
- •Inability to comply with study procedures
- •Gastrointestinal disorders
结局指标
主要结局
Score on the Pittsburgh Sleep Quality Index (PSQI)
时间窗: 4 weeks
The 19 questions which compose this survey assess sleep quality, latency, duration, habitual sleep efficiency, sleep disturbances, medication use and daytime dysfunction. Scores range 0 (minimum) to 21 (maximum) with \>5 indicating poor sleep quality so a lower score is a better outcome.
Sleep Fragmentation Index
时间窗: 4 weeks
Sleep Fragmentation is an index of restlessness during the sleep period expressed as a percentage (0 to 100%). The higher the index, the more sleep is disrupted.
Average Sleep Duration Per Night
时间窗: 4 weeks
Sleep duration will be actigraphy-derived.
次要结局
- Change in Urinary 6-sulfatoxymelatonin Level(Change from baseline to 4 weeks)
- Change in Tryptophan(Change from baseline to 4 weeks)
- Change in Kynurenine(Change from baseline to 4 weeks)
- Change in Serotonin(Change from baseline to 4 weeks)
研究者
Marie-Pierre St-Onge
Associate Professor of Nutritional Medicine
Columbia University