The Effect of Time-Restricted Eating in 24-hour Metabolic Homeostasis and Diurnal Rhythm
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Blood glucose concentration using a YSI analyzer
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 food intake during the rest of the day. In animals, TRE improves metabolic function without caloric restriction. However, an understanding of the effect of TRE on cardiometabolic health in people is not clear and few studies have evaluated this issue. This study is a randomized controlled trial in people with obesity and prediabetes/insulin resistance. The overall goal of the study is to determine the effect of 9 h TRE for 12 weeks on key metabolic outcomes that are risk factors for cardiovascular disease (CVD): The goal of this study is to answer the following questions: 1) 24-hour metabolic homeostasis 2) 24h diurnal rhythm and appetite regulation.
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
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •willing and able to give informed consent for participation in the study
- •aged 35-75 years
- •men and women
- •body mass index 27-45 kg/m2
- •fasting plasma glucose 5.6-6.9 mmol/L, or 2h OGTT plasma glucose 7.8-11.1 mmol/L or haemoglobin A1C 39-46 mmol/mol, 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)
- •type 1 or 2 diabetes
- •sleep disorder (individuals with well-controlled sleep apnoea)
- •eating disorder
- •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)
- •unable to grant voluntary informed consent or comply with the study instructions
- •individuals with electromedical devices
- •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 Eating (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
Blood glucose concentration using a YSI analyzer
时间窗: 3 months (pre-post intervention)
Changes in 24-h area under the curve for blood glucose concentration will be assessed during a 24h metabolic test day.
次要结局
- Serum insulin concentration using a chemiluminescent assay(3 months (pre-post intervention))
- Serum C-peptide concentration using an ELISA assay(3 months (pre-post intervention))
- Plasma FFA concentration using a colorimetric assay(3 months (pre-post intervention))
- Plasma TG concentration using a colorimetric assay(3 months (pre-post intervention))
- Serum GLP1 concentration using a V-plex assay(3 months (pre-post intervention))
- Serum GIP concentration using a V-plex assay(3 months (pre-post intervention))
- Hunger sensation using a standardised questionnaire (visual analog scale)(3 months (pre-post intervention))
研究者
Maria Chondronikola
Principal Investigator
Cambridge University Hospitals NHS Foundation Trust