Time Restricted Feeding for Weight Loss and Cardio-protection
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
- Body weight
研究概览
简要总结
Time restricted feeding (TRF) is a novel form of intermittent fasting that involves confining the period of food intake to 8 h/d (e.g. 10 am to 6 pm) without calorie counting. TRF is effective for weight loss and cardio-protection in obese adults. It is of great interest to see whether subjects can adhere to TRF for longer periods of time, and to see what degree of weight loss that can be achieved with TRF. Accordingly, the aims of this trial are: Aim 1: To determine if TRF can be implemented to facilitate weight loss in obese adults, and Aim 2: To determine if TRF can produce clinically meaningful reductions in plasma lipids, blood pressure, insulin resistance, and inflammatory markers.
详细描述
Time restricted feeding (TRF) is a novel form of intermittent fasting that involves confining the period of food intake to 8 h/d (e.g. 10 am to 6 pm) without calorie counting. Recent findings from short-term uncontrolled trials suggest that TRF is effective for weight loss and cardio-protection in obese adults. In view of these pilot findings, it is of great interest to see whether subjects can adhere to TRF for longer periods of time, and to see what degree of weight loss that can be achieved with TRF. Accordingly, the aims of this trial are: Aim 1: To determine if TRF can be implemented to facilitate weight loss in obese adults, and Aim 2: To determine if TRF can produce clinically meaningful reductions in plasma lipids, blood pressure, insulin resistance, and inflammatory markers. To test the study objectives, a 14-week randomized, controlled, parallel-arm trial, divided into 2 consecutive periods: (1) 2-week baseline; and (2) 12-week weight loss, will be implemented. Obese subjects (n = 40) will be randomized to 1 of 2 groups: (1) TRF (n = 20), or (2) control (n = 20). This study will be the first randomized controlled trial of TRF, and will show that TRF can be implemented to help obese individuals lose weight and lower risk of coronary heart disease.
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
- 25 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •Body mass index (BMI) between 30.0 and 40 kg/m2
- •Age between 25 and 65 years
- •Sedentary (light exercise less than 1 h per week) or moderately active (moderate exercise 1 to 2 h per week)
- •Weight stable for >3 months prior to the beginning of the study (gain or loss <4 kg)
- •Able to give written informed consent
排除标准
- •History of cardiovascular disease (myocardial infarction or stroke)
- •Taking weight loss medications
- •History of eating disorders
- •Night-shift workers
- •Perimenopausal
- •Pregnant or trying to become pregnant
研究组 & 干预措施
Time restricted feeding
Time restricted feeding
干预措施: Time restricted feeding (Other)
Control
No intervention
结局指标
主要结局
Body weight
时间窗: 12 weeks
次要结局
- Inflammatory markers: Tumor necrosis factor-alpha (TNF) and Interleukin-6 (IL-6)(12 weeks)
- Insulin resistance measured by Homeostatic model assessment (HOMA)(12 weeks)
- Blood pressure(12 weeks)
- Plasma lipids(12 weeks)
研究者
Krista Varady
Associate Professor
University of Illinois at Chicago
