Effects of Modified Intermittent Eating Strategy on Weight Loss and Cardiometabolic Risk Factors in Obese Adults: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Change in body weight over 12 months
研究概览
简要总结
Calorie restriction (CR) is the most important treatment for weighting loss. In recent years, two novel types of intermittent fasting recently have gained more attention: the 5:2 diet and time-restricted eating (TRE). TRE requires individuals to eat in a specified number of hours per day (typically 4 to 10 hours) without energy intake restriction. The 5:2 diet involves 5 feast days and 2 fast days per week; participants eat ad libitum without restriction on feast days while 25% of energy needs (approximately 500-800 kcal per day) are consumed on fast days. However, the effects of dietary strategy of intermittent fasting plus time-restricted eating (modified time-restricted eating: TRE 5 days and fasting 2days per week) on weight loss and cardiometabolic risk factors in obese adults have not been proved. This randomized controlled trial aimed to evaluate the effect of modified time-restricted eating (mTRE) and CR on weight loss and cardiometabolic risk factors in obese adults compared to usual health care over 12 months.
详细描述
Obesity is becoming a major global public health issue. Calorie restriction (CR) is the most important treatment for weighting loss. In recent years, two novel types of intermittent fasting recently have gained more attention: the 5:2 diet and time-restricted eating (TRE). TRE requires individuals to eat in a specified number of hours per day (typically 4 to 10 hours) without energy intake restriction. The 5:2 diet involves 5 feast days and 2 fast days per week; participants eat ad libitum without restriction on feast days while 25% of energy needs (approximately 500-800 kcal per day) are consumed on fast days. However, the effects of dietary strategy of intermittent fasting plus time-restricted eating (modified time-restricted eating: TRE 5 days and fasting 2days per week) on weight loss and cardiometabolic risk factors in obese adults have not been proved. This randomized controlled trial aimed to evaluate the effect of modified time-restricted eating (mTRE) and CR on weight loss and cardiometabolic risk factors in obese adults compared to usual health care over 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Man or women aged 18-75 years;
- •Body mass index (BMI)of 28.0 to 45.0 kg/m2;
排除标准
- •History of HIV, hepatitis B or C (self-report) or active pulmonary tuberculosis;
- •Diagnosis of type 1 and type 2 diabetes;
- •History of malignant tumors;
- •Serious liver dysfunction or chronic kidney disease (AST or ALT > 3 times the upper limit of normal, or eGFR<30 ml/min/1.73 m2);
- •History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
- •History of severe gastrointestinal diseases or gastrointestinal surgery in the past 12 months;
- •History of Cushing's syndrome, hypothyroidism, acromegaly, hypothalamic obesity;
- •Being a smoker or having been a smoker in the 3 months prior to their screening visit;
- •Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician;
- •Currently participating in weight loss programs or weight change in the past 3 months (> 5% current body weight) ;
- •Women who are pregnant or plan to become pregnant;
- •Patients who cannot be followed for 24 months (due to a health situation or migration);
- •Patients who are unwilling or unable to give informed consent.
结局指标
主要结局
Change in body weight over 12 months
时间窗: Baseline to months 12
Change in body weight over 12 months
次要结局
- Change in systolic blood pressure(Baseline to months 12)
- Change in liver fat(Baseline to months 12)
- Change in waist circumference(Baseline to months 12)
- Change in body mass index （BMI）(Baseline to months 12)
- Change in diastolic blood pressure(Baseline to months 12)
- Change in concentration of serum LDL-c(Baseline to months 12)
- Change in body fat composition meassured by DEXA(Baseline to months 12)
- Change in concentration of serum total cholesterol(Baseline to months 12)
- Change in concentration of HbA1c(Baseline to months 12)
- Change in insulin sensitivity(Baseline to months 12)
- Change in depression score measured by the Patient Health Questionnaire-9(Baseline to months 12)
- Change in quality of sleep score measured by the Pittsburgh sleep quality index(Baseline to months 12)
- Change in quality of life score measured by the 12-item Short-Form Health Survey Questionnaire(Baseline to months 12)
- Change in concentration of serum triglyceride(Baseline to months 12)
- Change in β cell function(Baseline to months 12)
- Change in arterial stiffness measured by pulse wave velocity(Baseline to months 12)