The Metabolic Impacts of Time-restricted Feeding in Men at High Risk of Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Glycaemia
研究概览
简要总结
This study will explore the effects of eight weeks of time-restricted feeding (TRF) on body weight and composition, glycaemic control, 24-hour glucose profiles, glucoregulatory hormones, and cardiovascular risk in men at high risk of type 2 diabetes. The investigators hypothesise that 8 weeks of TRF will reduce body weight, improve body composition, improve glycaemic control and blood lipid profiles. The potential mechanism will be explored in terms of the changes in gene expression patterns and multi-omics level (e.g., adipose tissue transcriptome, blood proteome).
详细描述
Following a 2 week baseline monitoring phase (food intake by smartphone APP, activity by accelerometer, glucose by continuous glucose monitor), participants will attend the metabolic clinic for testing (visit 0). Body weight, body composition (by DEXA), and blood pressure will be assessed. Blood and adipose tissue samples will be collected over 24-hour period for assessment of glucose, insulin, glucoregulatory hormones, blood lipids and adipose tissue transcriptome. Glucose and insulin responses to a standardised breakfast will be measured. All food will be provided for 3 days prior to the metabolic visit. Following visit 0, participants will be instructed to eat only within a 10-hour time frame each day for 8 weeks. Participants may self-select the precise window that best suits their lifestyles, however any food and drink must be consumed at least 3 hours prior to their usual bedtime. 24-hour glucose profiles, activity and food intake will be measured again at week 6-8. At the end of the 8 weeks, participants will return for a follow-up metabolic visit, identical to that at visit 0, except foods are provided with the 10h time frame.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Waist circumference ≥94 cm
- •Weight-stable (< 5 % fluctuation in their body weight for past 6-months at study entry)
排除标准
- •Personal history and/or diagnosis of: diabetes, cancer, major psychiatric disorders, liver disease, gastro-intestinal surgery or disease (including malabsorption), eating disorders, anaemia, insomnia, cardiovascular disease deemed unstable by the study physician.
- •use of prescribed or non-prescribed medications which may affect energy metabolism, gastrointestinal function, body weight or appetite, sleep (e.g: domperidone and cisapride, anticholinergic drugs (e.g.: atropine), metoclopramide, orlistat, thyroid medications, diuretics, glucocorticoids, sex steroids, metformin, dipeptidyl peptidase-IV inhibitors, melatonin)
- •recent weight change in past 3 months (> 5% current body weight)
- •individuals who regularly perform high intensity exercise (>2 week)
- •current intake of > 140g alcohol/week
- •current smokers of cigarettes/cigars/marijuana/e-cigarettes/vaporisers
- •current intake of any illicit substance
- •unable to comprehend study protocol
- •currently performing shift work
- •has undertaken, or is planning to undertake, trans meridian travel during the study period, or the preceding 60 days
- •do not own a smartphone
- •eats for less than a 12-hour period per day
研究组 & 干预措施
TRF
Participants will follow their regular diet for two weeks before 3-day lead-in food prior to the metabolic testing at visit 0. Participants will then be instructed to eat their habitual diet only within a 10-hour time frame each day for 8 weeks. Participants may self-select the precise window that best suits their lifestyles, however any food and drink must be consumed by 7:30pm.
干预措施: TRF (Behavioral)
结局指标
主要结局
Glycaemia
时间窗: 2.5 hours
Change in postprandial glucose (iAUC) following a standard breakfast
次要结局
- Body weight(8 weeks)
- Body composition(8 weeks)
- HbA1c(8 weeks)
- Blood lipids(8 weeks)
- Non-esterified fatty acid (NEFA)(8 weeks)
- Insulin(2.5 hours)
- Waist and hip circumference(8 weeks)
- Blood pressure(8 weeks)
- Plasma gastrointestinal (GI) hormones(8 weeks)
- Plasma Melatonin(8 weeks)
- 24-hour glucose profile(8 weeks)
- Adipose tissue transcriptome(8 weeks)
- Evening glycaemia(8 weeks)
- Plasma cortisol(8 weeks)
- Physical activity and sleep(8 weeks)
- Food intake and meal timing(8 weeks)
- Continuous glucose monitoring(8 weeks)
- Objective sleep(8 weeks)
研究者
A/Prof Leonie Heilbronn
A/Prof
University of Adelaide