Timing of Circadian Synchronizers: The TOCS Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Insulin sensitivity change from baseline
研究概览
简要总结
The overall goal is to examine the efficacy of a circadian intervention in people with overweight and obesity and habitual short sleep duration (HSSD). Participants will undergo a randomized controlled trial, with circadian intervention and control (healthy lifestyle) groups. The circadian intervention is designed to reduce nighttime light exposure and after-dinner snack food intake. Alternatively, the control group will receive basic health information (e.g., physical activity, goal setting, and nutrition when eating out).
详细描述
The study is a randomized controlled trial with control and circadian intervention groups. Group allocation will be blinded to research staff and participants until the conclusion of the baseline segment. The circadian intervention group will receive counseling and instruction to reduce evening and nighttime light exposure, increase morning room light and sunlight exposure, and complete all food consumption at least 4 hours before bedtime. Participants randomized to control will maintain their habitual food intake and sleep habits in their home environment for ~8 weeks. Both groups will have equal contact time with the study team.
Prior to enrollment participants will complete an clinical overnight sleep disorders screening. Baseline consists of an ~1-week ambulatory real-world monitoring segment. Following baseline participants will be randomized to the control or intervention groups for the 8 week experimental segment. Throughout the study sleep duration will be monitored using an actiwatch wrist-device and a daily electronic sleep log. At the end of the baseline and experimental segments participants will complete overnight laboratory visits to assess insulin sensitivity and circadian timing by oral glucose tolerance test and dim light melatonin onset, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Group allocation will be blinded to research staff and participants until the conclusion of the baseline segment.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-45 years old; equal numbers of men and women
- •Body mass index (BMI): 25.0-34.9 kg/m2,
- •Sleep Habits: habitual self-reported average total sleep time (TST) <6.5 hours per night for prior 6 months
排除标准
- •Clinically diagnosed sleep disorder or major psychiatric illness
- •Evidence of significant organ dysfunction or disease (e.g., diagnosed diabetes, cardiovascular disease, or kidney disease)
- •Use of prescription drugs or substances known to influence sleep or glucose metabolism
- •Shift-work: current or history of within last year
- •Weight change: >10% of body weight over prior six months
- •Experiencing menopause or post-menopausal
- •Current enrollment in weight loss or physical activity program like the Diabetes Prevention Program
- •Currently pregnant or planning to become pregnant, or currently lactating.
- •Currently smoking
- •Alcohol intake >3 drinks per day or >14 drinks per week
研究组 & 干预措施
Control Group
Provided with general health information on diet and physical activity.
Intervention Group
Circadian-based intervention focused on timing of light exposure and food intake.
干预措施: Circadian Intervention (Behavioral)
结局指标
主要结局
Insulin sensitivity change from baseline
时间窗: Change from baseline to end of the ~8 week experimental segment
Oral Glucose Tolerance Test (OGTT), Matsuda Index
次要结局
- Timing of central circadian clock change from baseline(Change from baseline to end of the ~8 week experimental segment)
- Plasma ceramides change from baseline(Change from baseline to end of the ~8 week experimental segment)
- Average (per week) self-reported sleep duration change from baseline(Analyzed as change from baseline for each week of the ~8 week experimental segment)
- Average (per week) sleep satisfaction change from baseline(Analyzed as change from baseline for each week of the ~8 week experimental segment)
- Average (per week) nightly total sleep time change from baseline(Analyzed as change from baseline for each week of the ~8 week experimental segment)
- Average (per week) timing of food intake change from baseline(Change from baseline to week 8 of the ~8 week experimental segment)
- Average (per week) daytime alertness change from baseline(Analyzed as change from baseline for each week of the ~8 week experimental segment)
研究者
Christopher Depner
Assistant Professor
University of Utah