Study of Time-restricted Eating on Weight Loss. A Randomized Controlled Trial of the Effects of Time-restricted Eating on Weight Loss in Obese Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 2
- 主要终点
- Weight Loss
研究概览
简要总结
This is a randomized controlled trial studying the effects of time-restricted eating (TRE) on weight loss in obese humans. Obesity is the number one risk factor for type 2 Diabetes Mellitus (T2DM), and numerous studies demonstrate that weight loss is an effective strategy to prevent T2DM and improve the metabolic health of people diagnosed with T2DM. Unfortunately, classical calorie restriction diets often fail to produce long-term weight loss due to low compliance, reduced resting metabolic rate (RMR), and other factors. Therefore, novel dieting techniques must be explored in order to successfully treat obesity and prevent T2DM. Studies in mice provide compelling evidence that feeding/fasting cycles can be altered to produce beneficial effects on weight loss and metabolic health markers in the absence of calorie restriction. Limited research in human subjects suggests that this feeding paradigm may translate to human health as well, however, more research needs to be done in order to confirm this hypothesis. This study will determine if TRE can lead to weight loss in obese human subjects. Secondary outcomes include changes in body composition, HOMA-IR, hormonal and biochemical serum markers, RMR, and total energy expenditure (TEE).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 30-40 kg/m2
- •Participants must regularly consume breakfast (at least 5 days per week)
- •Must speak, read, and comprehend English
- •Access to reliable internet and/or wifi
- •Must have a valid email address and phone number
- •Must have a cellular phone with data plan
排除标准
- •HIV or immunocompromised
- •Current or past cancer diagnosis
- •Pregnant, breastfeeding, or planned pregnancy in next 6 months
- •Beginning or ending hormonal contraception in next 6 months
- •Current diagnosis of type or type 2 diabetes
- •Currently taking glucose-lowering drugs, statins, or oral steroids
- •History of gastric bypass surgery or any other weight-loss surgery
- •History of anorexia or bulimia
- •Frequent travel across time zones or unusual work hours
- •Unable to fast for prolonged periods due to medical condition
- •Unable to stand for several minutes without aid
- •Cannot lie down on cushioned table for 30 minutes
- •No internal metal artifacts that would alter body composition
- •Unable to travel to UCSF for in-person testing
- •Requires translator services
结局指标
主要结局
Weight Loss
时间窗: Daily for 12 weeks
Measure changes in weight during the 12 week study
次要结局
- Changes in lean mass(Measured twice: Once at study start and once 12 weeks later)
- Fasting insulin levels(Measured twice: Once at study start and once 12 weeks later)
- Resting metabolic rate(Measured twice: Once at study start and once 12 weeks later)
- Total energy expenditure(Measured twice: Once at study start and once 12 weeks later)
- Changes in fasting glucose levels(Measured twice: Once at study start and once 12 weeks later)
- Fat loss(Measured twice: Once at study start and once 12 weeks later)
- Changes in HbA1c levels(Measured twice: Once at study start and once 12 weeks later)