Time-Restricted Feeding to Improve Glucose Tolerance and Vascular Condition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Change in Glucose Tolerance
研究概览
简要总结
The purpose of this pilot study is to find out what eating meals in a short time period early in the day (time-restricted feeding) versus eating meals spread out during the day (grazing) does to the body's ability to control blood sugar and to the health of its blood vessels.
The investigators hypothesize that time-restricted feeding will be more effective at improving glucose tolerance and vascular condition (inflammation and micro- and macro-vascular function) than grazing.
详细描述
Each participant will eat according to one of the two eating schedules (grazing or time-restricted feeding) for 5 weeks, have a 7-week washout period, and then eat according to the other eating schedule for 5 weeks. Measurements of glucose homeostasis and vascular condition will be performed before and after a participant follows each eating schedule.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Overweight: Have a body mass index between 25 and 50 kg/m^2 inclusive (a number calculated from height and weight)
- •Are 35-70 years of age
- •Have a hemoglobin A1C between 5.5 - 6.4% or prior medical indication of prediabetes
- •Have a blood sugar level between 140 and 199 mg/dL two hours after drinking a sugary solution (OGTT)
- •Have been eating dinner at least 8.5 hours after eating breakfast at least 90% of the time during the past year
- •Have not fasted (go for a day without any food) more than 12 days total during the past year
- •Be willing to eat most meals at Pennington Biomedical and/or under supervision
- •Not eat any food other than that served by Pennington Biomedical
- •Not drink any alcohol, juice, or other beverages that have calories other than what is served by Pennington Biomedical
- •Keep water and no-calorie drinks like tea or diet soda the same during both of the timed eating periods
- •Be willing to eat your meals according to the fixed schedules
排除标准
- •Have diabetes or are on anti-diabetes medication
- •Have evidence of cardiovascular disease
- •Suffer from significant cardiovascular, renal (kidney), cardiac (heart), liver, lung or nervous system disease
- •Evidence of significant gastrointestinal issues or surgery that impacts nutrient absorption
- •Regularly use medications such as steroids, beta blockers, and adrenergic-stimulating agents
- •Are on any regular medicine that has not had the same dose for 1 month or longer
- •Have a clinically significant abnormality as measured by a blood test
- •Regularly drink alcohol (more than 2 servings per day)
- •Have to do any kind of heavy physical activity
- •Currently perform overnight shift work more than one day a week
- •Are not able to eat only the food served to you by Pennington Biomedical, while in the study
- •Are not able to stop drinking alcohol or other drinks with calories (e.g., soda, juice) other than what is served to you by Pennington Biomedical, while in the study
研究组 & 干预措施
Time-Restricted Feeding (early in the day eating)
Participants will consume all meals early in the day and within a 6-hour window.
干预措施: Time-Restricted Feeding (Other)
Grazing
Participants will eat meals spread out over the course of the day.
干预措施: Grazing (Other)
结局指标
主要结局
Change in Glucose Tolerance
时间窗: Before and after 5 weeks on each feeding schedule
Glucose tolerance and indices of glucose homeostasis will be determined using an Oral Glucose Tolerance Test (OGTT).
次要结局
- Change in Vascular Function(Before and after 5 weeks on each feeding schedule)
- Change in Inflammation and Metabolic Markers(Before and after 5 weeks on each feeding schedule)
研究者
Courtney Peterson
Instructor
Pennington Biomedical Research Center