Nighttime Synchrony of Your Nutrition and Circadian Health: The N-Sync Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Insulin Sensitivity
研究概览
简要总结
Sleep is an important factor for overall health. This study will see how different light exposure patterns and food intake impact a person's metabolism (how the body breaks down food) when sleeping is reduced.
Participants will attend 6 to 8 in-person visits to the study clinic, including three overnight stays. People will complete surveys and medical tests. The study will last about 4 to 6 months.
详细描述
This study is a randomized in-lab, cross-over trial. Each participant will complete all three arms in either condition order #1 (A-B-C) or order #2 (A-C-B). Each arm will consist of 5 nights of experimental sleep restriction followed by a constant routine protocol for assessment of 24-h rhythms. Sleep restriction in the three arms will occur under the following conditions: (A-control condition) Sleep Restriction with Central and Peripheral Alignment; (B) Sleep Restriction with Central Clock Misalignment; and (C) Sleep Restriction with Peripheral Misalignment. Prior to enrollment participants will complete a comprehensive medical history and clinical overnight sleep disorders screening. Baseline consists of a ~2-week ambulatory real-world monitoring segment that will occur immediately prior to each in-lab sleep restriction condition. Following the 5 days of sleep restriction in each arm, participants will complete an intravenous glucose tolerance test to analyze insulin sensitivity, prior to completing the constant routine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Randomization to condition order will be concealed to research staff and participants until the conclusion of the condition "A", which all participants will complete first.
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
- •Age: 18-35 years old; equal numbers of men and women
- •Body Mass Index (BMI): 18.5-24.9 kg/m2
- •Sleep Habits: habitual self-reported average total sleep time (TST) 7-9 hours per night for prior 6 months
排除标准
- •Clinically diagnosed sleep disorder or apnea hypopnea index (AHI) ≥5
- •Evidence of significant organ system dysfunction or disease (e.g., heart disease, diabetes)
- •Fasting plasma glucose ≥100 mg/dL
- •Major psychiatric illness (e.g., major depressive disorder)
- •Cancer that has been in remission less than 5 years
- •History of shift-work in prior year
- •Weight change >5% of body weight over prior six months
- •Currently following a weight-loss program
- •Pregnant/nursing
- •Greater than 5-day variation in menstrual cycle length month-to-month
- •Currently smoking
- •Alcohol intake >14 drinks/week or >3 drinks/day.
- •Use of prescription medications (except oral contraceptives) within one month prior to or during in-lab visits.
- •Consumption of illegal drugs or >500mg per day of caffeine.
研究组 & 干预措施
Sleep Restriction with Central and Peripheral Alignment
(Arm "A")-Control condition with central and peripheral aligned circadian rhythms
Sleep Restriction with Central Clock Misalignment
(Arm "B")-Misalignment of the central clock by nighttime electrical light exposure and dim-light in morning hours.
干预措施: Central Clock Misalignment (Behavioral)
Sleep Restriction with Peripheral Misalignment
(Arm "C")-Misalignment of peripheral oscillators by shifting the majority of food intake to the nighttime hours.
干预措施: Peripheral Misalignment (Behavioral)
结局指标
主要结局
Insulin Sensitivity
时间窗: Immediately following the 5-day sleep restriction segment
Insulin sensitivity will be measured by intravenous glucose tolerance tests.
Internal Circadian Misalignment (Uridine and Isobutyryl-L-carnitine)
时间窗: During the constant routine, following the 5-day sleep restriction segment
Phase angle between DLMO and acrophase of uridine and isobutyryl-L-carnitine during constant routine.
次要结局
未报告次要终点
研究者
Christopher Depner
PhD
University of Utah