Feasibility of Implementing Time-restricted Eating in Women With Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Number of participants adhering to TRE protocol
研究概览
简要总结
This study will investigate the feasibility of implementing a time-restricted eating intervention in females with mild cognitive impairment. Targeted therapeutic interventions that improve cognitive impairment and delay onset of ADRD are particularly important for females, who have twice the lifetime risk of developing AD, compared to males.
详细描述
This study will investigate the feasibility of implementing a time-restricted eating (TRE) intervention in females with mild cognitive impairment. Data will be collected for 10 weeks. Baseline food timing, activity/sleep, metabolic health (fasting labs and anthropometric measures), and cognitive testing will be collected in the first two weeks. Subjects will then be invited to enroll in a TRE intervention for 8 weeks. Subjects will be educated about the potential health benefits of TRE, and then each subject will self-select a 10-hr window and consume all daily calories during this time frame. Subjects will text the time of their first and last daily calories for the duration of the study. At the end of the 8-week TRE intervention, metabolic, anthropometric, activity/sleep, and cognitive measurements will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 95 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal Women
- •Age 45-95
- •Diagnosis of mild cognitive impairment
排除标准
- •Individuals prone to hypoglycemia
- •Liver disease
- •Taking medications that affect eating behaviors
- •Alcohol consumption of >2 drinks per day
- •Significant circadian disruption
- •Having care-taking responsibilities that significantly affect sleep
- •Shift work or irregular lifestyle
- •Diagnosed clinical eating disorder
- •Participating in a formal weight loss program
研究组 & 干预措施
Time-restricted eating
Participants will have baseline and post-study data collected, including activity/sleep data, metabolic parameters (fasting labs and anthropometric measurements), and cognitive testing. In addition, food timing will be collected throughout the study. Subjects will be educated about the potential health benefits of time-restricted eating and will self-select a 10-hr window, during which all daily calories will be consumed for 8 weeks.
干预措施: Time-restricted eating (Behavioral)
结局指标
主要结局
Number of participants adhering to TRE protocol
时间窗: From enrollment to study completion up to approximately 8 weeks
The times of first and last meals will be collected from participants with an SMS texting system. Adherence defined as minimum 10 hour (+/- 1hr) TRE window 5 days per week.
次要结局
未报告次要终点
研究者
Julie Pendergast
Associate Professor
University of Kentucky