Development of Countermeasures Against Adverse Metabolic Effects of Shift Work
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in plasma leptin levels across sleep/wake cycle
研究概览
简要总结
The goal of this application is to determine whether changing the timing of food intake prevents the adverse metabolic effects of circadian misalignment.
详细描述
Shift work is associated with circadian misalignment and an increased risk for the development diabetes, obesity, and cardiovascular disease. This research will determine whether changing the feeding schedule can prevent metabolic alterations that can lead to the abovementioned disorders. This research will provide mechanistic insight and may provide a novel therapeutic approach against the increased risk for diabetes, obesity, and cardiovascular disease among shift workers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 18.5 and 29.9 kgm-2
- •Healthy adults with regular sleep-wake timing
- •Non-smokers
- •Completion of medical and psychological screening tests
- •Able to spend 14 consecutive days in the sleep laboratory
排除标准
- •BMI <18.5 or > 29.9 kgm-2
- •History of neurological or psychiatric disorder
- •History of sleep disorder or regular use of sleep-promoting medication
- •Current prescription, herbal, or over-the-counter medication use
- •Traveling across 2 or more time zones within past 3 months
- •Donating blood within past 8 weeks
- •Worked night or rotating shift work within past 3 years
- •Hearing impairment
- •Drug or alcohol dependency
研究组 & 干预措施
Experimental
During Forced Desynchrony sleep and wake will occur at different circadian phases, while meals are restricted to the biological day.
干预措施: Meal schedule (Behavioral)
Control
During Forced Desynchrony sleep and wake, as well as meals, will occur at different circadian phases.
干预措施: Meal schedule (Behavioral)
结局指标
主要结局
Change in plasma leptin levels across sleep/wake cycle
时间窗: During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Frequent blood samples
Change in circadian profile of plasma leptin
时间窗: During constant routine before forced desynchrony (Days 3-4) and constant routine after forced desynchrony (Days 12-13)
Frequent blood samples
Change in plasma insulin levels after standardized test meal
时间窗: During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Frequent blood samples before and after standardized meals
Change in circadian profile of plasma insulin levels
时间窗: During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Frequent blood samples
Change in glucose tolerance
时间窗: During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Frequent blood samples before and after standardized meals
Change in circadian profile of plasma glucose levels
时间窗: During circadian alignment (Day 7) and circadian misalignment (Day 10-11)
Frequent blood samples
次要结局
- Changes in sleep(sleep periods following day 1, days 6-7 and days 10-11)
- Changes circadian rhythm in resting energy expenditure(During constant routine before forced desynchrony (Days 3-4) and constant routine after forced desynchrony (Days 12-13))
- o Change in circadian phase markers, such as from core body temperature, melatonin, and cortisol(Core temperature and frequent blood samples)
- Change in hunger and appetite, mood, and cognitive performance(Tests taken throughout the protocol, days 1-14)
- Changes in microbiota, gene expression, epigenetic or proteomic markers(samples taken during forced desychrony (days 7-11) and the constant routine protocols (days 3-4 and 11-13))
研究者
Frank AJL Scheer, PhD
Frank AJL Scheer, PhD
Brigham and Women's Hospital