Circadian Rhythms in Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- Change in Body Mass Index
研究概览
简要总结
This is a randomized, parallel two-arm clinical trial design to study the efficacy of time-restricted feeding on metabolic risk in postmenopausal women, who may be particularly vulnerable to disruption of circadian eating rhythms and the associated metabolic dysfunction. It is hypothesized that time-restricted feeding will improve insulin sensitivity, glucose tolerance, body weight, and other metabolic parameters in metabolically-unhealthy postmenopausal women.
详细描述
This is a randomized, parallel two-arm clinical trial design to study the efficacy of time-restricted feeding (TRF) on metabolic risk in postmenopausal women. Data will be collected for 18 weeks. Baseline food timing, activity/sleep, and metabolic parameter (OGTT, body composition, anthropometric measurements, lipid panel, inflammatory markers) data will be collected in the first two weeks (baseline). Subjects will then be randomized to the TRF intervention or no TRF for 16 weeks. Subjects in the TRF group will be educated about the health benefits of TRF. Then each subject in the TRF group will self-select a 10-h window and consume all daily calories during this time frame. Subjects in both the TRF and no TRF groups will text the time of their first and last daily meals for the duration of the study. At the end of the 16-week TRF intervention or no TRF, metabolic and anthropometric measurements will be collected.
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
- None
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •postmenopausal women
- •age 45-65 years
- •prediabetic or have at least 2 features of metabolic syndrome
排除标准
- •on hormone therapy
- •heart disease
- •alcohol consumption of >2 drinks per day
- •significant circadian disruption
- •having care-taking responsibilities that significantly affect sleep
- •shift work or irregular lifestyle
- •uncontrolled sleep apnea or other uncontrolled sleep disorder
- •extreme early or late chronotypes
- •significant psychiatric disorders
- •taking ADHD medications
- •diagnosed dysregulated eating behaviors
- •smoking >5 cigarettes/day or 30 pack-year history
- •participating in formal weight loss program
- •not weight stable
研究组 & 干预措施
Time-Restricted Feeding (TRF) Group
Participants in this group will have baseline and post-study data collected, including food timing, activity/sleep data, and metabolic parameters (OGTT, body composition, anthropometric measurements, lipid panel, inflammatory markers). Subjects in this group will be educated about the health benefits of time-restricted feeding (TRF). Then each subject in the TRF group will self-select a 10-h window during which she will consume all daily calories for 16 weeks.
干预措施: Time-Restricted Feeding (TRF) (Behavioral)
Control
Participants in this group will have baseline and post-study data collected, including food timing, activity/sleep data, and metabolic parameters (OGTT, body composition, anthropometric measurements, lipid panel, inflammatory markers). There will be no intervention.
结局指标
主要结局
Change in Body Mass Index
时间窗: 18 weeks (baseline and post-intervention)
Body mass index will be calculated from height and weight.
Change in Triglycerides
时间窗: 18 weeks (baseline and post-intervention)
Triglycerides will be measured from fasting blood
Change in Insulin Sensitivity
时间窗: 18 weeks (baseline and post-intervention)
Matsuda index will be assessed by the oral glucose tolerance test (OGTT).
次要结局
- Change in Hemoglobin A1c(18 weeks (baseline and post-intervention))
- Change in Mid-sleep(18 weeks (baseline and post-intervention))
- Change in C-Reactive Protein(18 weeks (baseline and post-intervention))
- Change in Sleep Fragmentation Index(18 weeks (baseline and post-intervention))
研究者
Julie Pendergast
Assistant Professor
University of Kentucky