NCT05700643已完成1 期
Effects of Montmorency Cherry Supplementation on Sleep and Inflammatory Outcomes
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Change in insomnia symptoms
研究概览
简要总结
This study will test the effects of Montmorency cherry supplementation on sleep outcomes and inflammatory biomarkers.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •body mass index (BMI) of ≥ 25.0 kg/m2;
- •sleep issues as identified by a global score of 5 or greater on the Pittsburgh Sleep Quality Index (PSQI) and/or a score 8 or higher on the Insomnia Severity Index (ISI);
- •ability to adhere to a diet low in antioxidants during the study period; and
- •willingness to wear a Fitbit for the duration of the study and to wear the Zmachine on selected nights.
排除标准
- •unwilling or unable to stop the use of sleep medication
- •unable to attend laboratory visits on the East Lansing, Michigan campus
结局指标
主要结局
Change in insomnia symptoms
时间窗: Through study completion, two weeks for each arm
Insomnia Severity Index scores, scores range from 0-28, higher scores indicate worse outcomes
Change in total sleep time
时间窗: Through study completion, two weeks for each arm
sleep duration in hours and minutes
Change in sleep quality
时间窗: Through study completion, two weeks for each arm
Pittsburgh Sleep Quality Index scores, scores range from 0-21, higher scores indicate worse outcomes
次要结局
- Change in Interleukin-8(Through study completion, two weeks for each arm)
- Change in Interleukin-17(Through study completion, two weeks for each arm)
- Change in Tumor necrosis factor-alpha(Through study completion, two weeks for each arm)
- Change in Interleukin-6(Through study completion, two weeks for each arm)
- Change in C-reactive protein(Through study completion, two weeks for each arm)
- Change in Anthropometrics(Through study completion, two weeks for each arm)
研究者
Robin Tucker
Associate Professor
Michigan State University
研究点 (2)
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