The Effect of Timed-Restricted Eating on Insulin Sensitivity, De Novo Lipogenesis and Liver Fat in Subjects With Obesity and Insulin Resistance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Insulin Sensitivity
研究概览
简要总结
We aim to determine the effect of combined isocaloric time restricted eating and meal timing on metabolic health, liver fat, functional brain networks, inflammation, and sleep pattern/quality in subjects with obesity and insulin resistance.
详细描述
Obesity is an alarming global health issue, with increasing prevalence. Obesity leads to a vast array of disorders, including dyslipidemia, the accumulation of intrahepatic triglycerides (IHTG), multiorgan insulin resistance and type 2 diabetes mellitus. In addition, disruption of the circadian rhythm (circadian misalignment), which is associated with irregular eating schedules, is an important risk factor for the development of obesity, IHTG and type 2 diabetes mellitus. Time restricted eating (TRE) is a form of intermittent fasting, in which the daily eating period is restricted. The beneficial effect of this type of diet might relate to adequate synchronization of food intake and fasting to the internal rhythm of the circadian tissue clocks, improving metabolic handling of nutrients and metabolic flexibility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to provide informed consent;
- •BMI > 30kg/m^2;
- •Insulin resistance, as defined by fasting plasma insulin > 62 pmol/L and/or prediabetes, as defined by fasting plasma glucose > 5.3 and < 7.0 mmol/L;
- •Stable weight for 3 months prior to study inclusion
- •For women, 1 year after last menstrual cycle
排除标准
- •Use of any medication, except for those related to treatment of metabolic syndrome;
- •Any medical condition interfering with study outcomes or design;
- •History of any psychiatric disorder, including eating disorders;
- •Performing shift work
- •Performing intensive sports (>3 hours/week);
- •Drugs abuse or alcohol abuse (>3 units/day);
- •Contraindication for MRI;
- •Known lactose/gluten intolerance;
- •Known soy, egg, milk or peanut allergy;
- •Childhood onset of obesity
结局指标
主要结局
Insulin Sensitivity
时间窗: Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2
We will use the Oral Minimal Model Method in conjunction with a Mixed Meal Tolerance Test (MMTT) to quantitatively evaluate insulin sensitivity. Concentrations of insulin, glucose, and C-peptide will be measured during the course of the MMTT to serve as the requisite inputs for the model. The output is in dl/kg/min/uU/ml.
次要结局
- Change in plasma glucose(Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2)
- Change in beta cell function (C-peptide)(Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2)
- De novo lipogenesis(Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2)
- Change in intrahepatic fat(Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2)
- Immunological markers(Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2)
- Change in insulin aignaling(Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2)
- Change in glucose variability(Baseline 1 to week 4 for intervention 1, Baseline 2 to week 12 for intervention 2)
- Psychological factor - Food Craving(Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2)
- Psychological factor - Food addiction(Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2)
- Change in plasma insulin(Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2)
- Physical activity(Baseline 1 to week 4 for intervention 1, Baseline 2 to week 12 for intervention 2)
- Psychological factor - Impulsiveness(Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2)
- Functional brain activity(Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2)
- Iowa gambling computational task(Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2)
- Psychological factor - Eating behaviour(Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2)
- Psychological factor - Hunger scale(Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2)
- Delay discounting computational task(Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2)
- Psychological factor - Chronotype(Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2)
- Subject experience with intervention(Baseline 1 and week 4 for intervention 1; Baseline 2 and week 12 for intervention 2)
研究者
Prof. Dr. Mireille JM Serlie
MD PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)