The Effect of Time-Restricted Eating in Cardiometabolic Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Insulin sensitivity
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
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •must be able to grant voluntary informed consent and comply with the study instructions
- •aged 25-75 years
- •men and women
- •body mass index 27-45 kg/m2
- •fasting plasma glucose 5.6-6.9 mmol/L, or 2h oral glucose tolerance test plasma glucose 7.8-11.1 mmol/L or haemoglobin A1C 39-46 mmol/mol or homeostasis model assessment-insulin resistance (HOMA-IR) score ≥2.73
- •self-reported habitual eating period ≥ 13 h per day
排除标准
- •shift worker
- •fasting >12 h/day more than once a week
- •> once a week no food intake after ~1800 h
- •habitually waking up before ~0400 h and sleeping before ~2100 h
- •unstable weight (>5% change the last 2 months)
- •Clinical diagnosis of type 1 or 2 diabetes
- •Clinical diagnosis of sleep disorder
- •Clinical diagnosis of eating disorder
- •Clinical diagnosis of cancer in last 5 years
- •conditions that render subject unable to complete all testing procedures (including individuals with known allergies or contraindications to the medications used in this study)
- •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
- •gastrointestinal or bariatric surgery (except cholecystectomy and appendectomy)
- •individuals with electromedical devises
- •prisoners
- •alcohol abuse
研究组 & 干预措施
TRE group
Participants assigned to the TRE group will have to consume all their daily meals and snacks during a 9-hour window for 12 weeks.
干预措施: Time restricted eating (Behavioral)
TRE group
Participants assigned to the TRE group will have to consume all their daily meals and snacks during a 9-hour window for 12 weeks.
干预措施: Healthy diet (Behavioral)
Control group
Participants assigned to the control group will have to consume all their daily meals and snacks during a 14-hour window for 12 weeks.
干预措施: Extended eating window (Behavioral)
Control group
Participants assigned to the control group will have to consume all their daily meals and snacks during a 14-hour window for 12 weeks.
干预措施: Healthy diet (Behavioral)
结局指标
主要结局
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.
次要结局
- 24 h glycemic control(3 months (pre-post intervention))
- Adipose tissue gene expression(3 months (pre-post intervention))
研究者
Maria Chondronikola
Principal Investigator
Cambridge University Hospitals NHS Foundation Trust