Time Restricted Feeding (4-hour Versus 6-hour) for Weight Loss in Obese Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Change from baseline to week 8 in body weight
研究概览
简要总结
The aims of this proposal are to compare the effects of 4-h versus 6-h time restricted feeding (TRF) on body weight and metabolic disease risk factors in adults with obesity. To test the study objectives, a 10-week randomized, controlled, parallel-arm trial, divided into 2 consecutive periods: (1) 2-week baseline period; and (2) 8-week TRF weight loss period, will be implemented. Obese subjects will be randomized to 1 of 3 groups: (1) 4-h TRF, (2) 6-h TRF, or a no-intervention control group. This study will be the first randomized controlled trial to compare 4-h versus 6-h TRF.
详细描述
Modest weight loss of 5-10% is sufficient to reduce metabolic disease risk in obese individuals. The first line of therapy prescribed for weight loss is daily calorie restriction (CR; 25% restriction every day). However, adherence to CR greatly diminishes after 4-6 weeks, due to subject frustration with constantly having to count calories and never being able to eat freely. In light of these issues with CR, another approach that limits timing of food intake, instead of number of calories consumed, has been developed. This strategy is termed time restricted feeding (TRF), and involves confining the period of food intake to 8 h/d (10 am to 6 pm) without calorie counting. Preliminary findings of 8-h TRF demonstrate modest weight loss and blood pressure reductions after 12 weeks. What remains unknown however, is whether shorter feeding windows during TRF (such as 4-h or 6-h feeding windows) can produce even greater weight loss in obese adults. Also of interest, is the impact of these shorter feeding windows on metabolic disease risk indicators (such as plasma lipids, blood pressure, and insulin resistance, inflammation and oxidative stress). Accordingly, the aims of this proposal are: AIM 1: To compare the effects of 4-h versus 6-h time restricted feeding (TRF) on body weight in adults with obesity; AIM 2: To compare the effects of 4-h versus 6-h TRF on metabolic disease risk factors in adults with obesity. To test the study objectives, a 10-week randomized, controlled, parallel-arm trial, divided into 2 consecutive periods: (1) 2-week baseline period; and (2) 8-week TRF weight loss period, will be implemented. Obese subjects will be randomized to 1 of 3 groups: (1) 4-h TRF, (2) 6-h TRF, or a no-intervention control group. This study will be the first randomized controlled trial to compare 4-h versus 6-h TRF on body weight and metabolic disease risk markers.
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
- 18 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 49.9 kg/m2;
- •age between 18 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
- •Smoker; diabetic;
- •taking weight loss medications;
- •taking medication that requires eating food before (or with) the medication; history of eating disorders;
- •night-shift workers;
- •perimenopausal;
- •pregnant women
结局指标
主要结局
Change from baseline to week 8 in body weight
时间窗: Measured at week 1 and 8
Measured by an electronic scale
次要结局
- Change from baseline to week 8 in body composition(Measured at week 1 and 8)
- Change from baseline to week 8 in Blood pressure(Measured at week 1 and 8)
- Change from baseline to week 8 in inflammatory markers (TNF-a, IL-6)(Measured at week 1 and 8)
- Change from baseline to week 8 in physical activity (steps/d)(Measured at week 1 and 8)
- Change from baseline to week 8 in Fasting glucose(Measured at week 1 and 8)
- Change from baseline to week 8 in Fasting insulin(Measured at week 1 and 8)
- Change from baseline to week 8 in sleep quality(Measured at week 1 and 8)
- Change from baseline to week 8 in heart rate(Measured at week 1 and 8)
- Change from baseline to week 8 in insomnia severity(Measured at week 1 and 8)
- Change from baseline to week 8 in plasma lipids(Measured at week 1 and 8)
- Change from baseline to week 8 in calorie and macronutrient intake(Measured at week 1 and 8)
- Change from baseline to week 8 in sex steroid levels (estrogen, androgens, sex hormone binding globulin)(Measured at week 1 and 8)
- Change from baseline to week 8 in Insulin resistance(Measured at week 1 and 8)
- Change from baseline to week 8 in adverse events(Measured weekly from baseline to week 8)
- Change from baseline to week 8 in oxidative stress (8-isoprostane)(Measured at week 1 and 8)
- Change from baseline to week 8 in diet adherence(Measured weekly from baseline to week 8)
- Change from baseline to week 8 in risk of sleep apnea(Measured at week 1 and 8)
研究者
Krista Varady
Professor of Nutrition
University of Illinois at Chicago