The Effect of Time-Restricted Eating in Cardiometabolic Health
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Adipose tissue gene expression
研究概览
简要总结
Time-restricted eating (TRE) is a dietary manipulation that involves restricting food intake to 6-12 h/day with no energy intake the rest of the day. In rodents, TRE improves metabolic function without caloric restriction, potentially by activating nutrient sensing mechanisms and effects on circadian oscillations. However, an understanding of the effect of TRE on cardiometabolic health in people is not clear and few studies have evaluated this issue. Accordingly, the investigators propose to conduct a randomized controlled trial in people with obesity and prediabetes to determine the effect of 9 h TRE for 12 weeks, without a change in body weight, on key metabolic outcomes that are risk factors for cardiovascular disease (CVD): 1) multi-organ insulin sensitivity; 2) 24 h metabolic homeostasis and diurnal rhythm; and 3) adipose tissue and skeletal muscle biology. The proposed studies will elucidate the cardiometabolic implications of TRE in people with obesity and prediabetes.
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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •body mass index 30-39.9 kg/m2
- •fasting plasma glucose 100-125 mg/dl, or 2h OGTT plasma glucose 140-199 mg/dl or hemoglobin A1C 5.7-6.4%
- •self-reported habitual eating period > 15 h per day
排除标准
- •shift worker, recent or expected travel crossing time zones
- •fasting >12 h/day more than once a week or vegan
- •shift worker, recent or expected travel crossing time zones
- •fasting >12 h/day more than once a week or vegan
- •> once a week no food intake after 1800 h
- •habitually waking up before 0400 h and sleeping before 2230 h
- •≥ 150 min per week of structured exercise
- •unstable weight (>5% change the last 2 months)
- •type 2 diabetes or other major chronic disease
- •sleep disorder
- •cancer in last 5 years
- •conditions that render subject unable to complete all testing procedures
- •use of medications that affect the study outcome measures or increase the risk of study procedures and that cannot be temporarily discontinued (e.g., steroids, alpha or beta adrenergic blockers or agonists, etc.)
- •smoking and illegal drug use
- •pregnant or lactating
- •menopause
- •individuals that have performed procedures involving substantial exposure to radiation in the last 12 months
- •gastrointestinal or bariatric surgery
- •unable to grant voluntary informed consent or comply with the study instructions
- •individuals who are not yet adults (infants, children, teenagers)
- •prisoners
结局指标
主要结局
Adipose tissue gene expression
时间窗: 3 months (pre-post intervention)
Changes in the expression of genes involved in energy metabolism will be assessed by using qPCR.
Insulin sensitivity
时间窗: 3 months (pre-post intervention)
Insulin sensitivity will be assessed by using a hyperinsulinemic euglycemic clamp procedure in conjunction with infusion of stable isotope tracers.
24 h glycemic control
时间窗: 3 months (pre-post intervention)
Changes in plasma glucose concentration will be assessed during a 24 h feeding study.
次要结局
- Peripheral diurnal rhythmicity in in peripheral mononuclear blood cells(3 months (pre-post intervention))