NCT03745612已完成不适用
Effects of Time-Restricted Feeding on Weight Loss and Cardiometabolic Risk Factors in Obese Adults: a Randomized Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 1
- 主要终点
- Change in body weight over 12 months
研究概览
简要总结
Time restricted feeding (TRF) is a novel type of intermittent calorie restriction diet that involves eating a daily period of 8 hours or less. This is a randomized controlled trial to evaluate the effect of time restricted feeding (TRF) on weight loss and cardiometabolic risk factors in obese adults over 12 months compared to continuous energy restriction (CER).
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
- •Male of female aged between 18 and 75 years old;
- •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 12 months
次要结局
- Change in blood lipids(Baseline to 12 months)
- Change in body composition(Baseline to 12 months)
- Change in waist circumference(Baseline to 12 months)
- Change in liver fat(Baseline to 12 months)
- Change in visceral fat(Baseline to 12 months)
- Change in HbA1c(Baseline to 12 months)
- Change in Blood pressure(Baseline to 12 months)
- Change in insulin sensitivity(Baseline to 12 months)
- Change in β cell function(Baseline to 12 months)
- Change in pulse wave velocity (PWV)(Baseline to 12 months)
- Depression measured by the Patient Health Questionnaire-9 (PHQ-9)(Baseline to 12 months)
- Quality of sleep measured by the Pittsburgh sleep quality index (PSQI)(Baseline to 12 months)
- Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12)(Baseline to 12 months)
研究者
研究点 (1)
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