Time-restricted Feeding as a Dietary Strategy Against Metabolic Disturbances in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Insulin sensitivity
研究概览
简要总结
This human dietary intervention study with a cross-over design aims to compare the effects of two isocaloric diets - early time-restricted feeding (TRF) vs. late TRF - on glycemic control and lipid metabolism in overweight and obese women.
详细描述
The participants are randomly allocated to one of two study groups: In study group (A) participants will begin with the early TRF (e-TRF) intervention. They will consume their habitual food (and the habitual daily amount of food) between 8 am and 4 pm for two weeks. After a washout-phase participants will conduct the late TRF (l-TRF) and consume their habitual food between 1 pm and 9 pm for another two weeks. Study group (B) receives the same interventions in the reversed order. Both dietary regimens will result in 8-hr eating period and 16-hr fasting period during the 24h day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •BMI 25-35 kg/m²
排除标准
- •prior diagnosis of type 1 or 2 diabetes
- •weight changes > 5% within past 3 months
- •current shift work or history of shift work
- •traveled across more than one time zone one month before the study
- •poor quality of sleep (PSQI score>10)
- •eating disorders, food intolerance/allergy, severe indigestion
- •Pregnant or breastfeeding
- •severe internal or psychiatric disorders or other conditions that might influence the outcome of the study
结局指标
主要结局
Insulin sensitivity
时间窗: 2 weeks
Assessed using Matsuda index in oral glucose tolerance test (OGTT)
次要结局
- Metabolic hormones and inflammatory markers(2 weeks)
- Blood lipids(2 weeks)
- Anthropometric parameters: fat and lean mass(2 weeks)
- Food intake: macronutrient composition(14 days)
- Sleep quality and timing(2 weeks (PSQI) and 14 days (ActiGraph, sleep diary))
- Glucose tolerance, fasting glucose, and overall daily glycemic variation(2 weeks (OGTT) and 14 days (CGM))
- Oxidative stress markers(2 weeks)
- Food intake: eating times(14 days)
- Food intake: calorie intake(14 days)
- Anthropometric parameters: BMI(2 weeks)
- Physical activity(14 days)
- Anthropometric parameters: waist circumference(2 weeks)
- Blood pressure(2 weeks)
- Liver enzymes(2 weeks)
- Anthropometric parameters: body weight(2 weeks)
- Satiety and hunger scores(2 weeks)
- Expression of metabolic genes in adipose tissue(2 weeks)
- Social and economic decision behaviour(2 weeks)
研究者
Olga Ramich (formerly Pivovarova)
project director
German Institute of Human Nutrition