Effects of Intermitting Eating on Weight-Loss Maintenance 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
- 270
- 试验地点
- 1
- 主要终点
- Change in body weight over 12 months
研究概览
简要总结
Weight regain after weight loss is a major problem in the treatment of obesity. Two novel types of intermittent fasting recently have received 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 day. This randomized controlled trial aimed to evaluate the effect of TRE and the 5:2 diet on weight loss maintenance and cardiometabolic risk factors after a low-calorie diet in obese adults over 12 months compared to usual health care.
详细描述
Weight regain after weight loss is a major problem in the treatment of persons with obesity. Two novel types of intermittent fasting recently have received 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 day. Preliminary evidence suggests that both TRE and the 5:2 diet have beneficial effects on weight loss and cardioprotection in humans. Whether TRE or the 5:2 diet is an effective approach for weight-loss maintenance remains unknown. This randomized controlled trial aimed to evaluate the effect of TRE and the 5:2 diet on weight loss maintenance and cardiometabolic risk factors after a low-calorie diet in obese adults over 12 months compared to usual health care. All participants who have achieved greater than 5% of weight loss after a 8-week low-calorie-diet induced weight loss phase, will be assigned to one of the three study groups (TRE, the 5:2 diet and control groups) in a 1:1:1 ratio. Participants in the TRE group will be instructed to eat during a window of 8 h/d (8 am to 4 pm) over 12 months. Participants in the 5:2 diet group will be instructed to consume 500-600 kcal/d on fast days and eat ad libitum on feast days. Participants in the control group were instructed to receive usual health care.
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
- •1.Man or women aged 18-75 years;
- •2.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.
研究组 & 干预措施
The TRE group
Participants in the TRE group will be instructed to eat during a window of 8 h/d (8 am to 4 pm).
干预措施: Time-restricted eating (Behavioral)
The 5:2 diet group
Participants in the 5:2 diet group will be instructed to consume 500-600 kcal/d on fast days and eat ad libitum on feast days.
干预措施: The 5:2 diet (Behavioral)
Control
Participants in the control group will receive a general lifestyle counseling.
结局指标
主要结局
Change in body weight over 12 months
时间窗: Baseline to months 12
次要结局
- Change in quality of sleep score measured by the Pittsburgh sleep quality index(Baseline to months 12)
- Change in depression score measured by the Patient Health Questionnaire-9(Baseline to months 12)
- Change in arterial stiffness measured by pulse wave velocity(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 body fat composition meassured by DEXA(Baseline to months 12)
- Change in waist circumference(Baseline to months 12)
- Change in serum LDL-c(Baseline to months 12)
- Change in insulin sensitivity(Baseline to months 12)
- Change in liver fat(Baseline to months 12)
- Change in systolic blood pressure(Baseline to months 12)
- Change in body mass index(Baseline to months 12)
- Change in serum triglycerides(Baseline to months 12)
- Change in serum total cholesterol(Baseline to months 12)
- Change in HbA1c(Baseline to months 12)
- Change in diastolic blood pressure(Baseline to months 12)
- Change in β cell function(Baseline to months 12)
研究者
Huijie Zhang
Professor
Nanfang Hospital, Southern Medical University