Effects of Time-Restricted Feeding on Nonalcoholic Fatty Liver Disease in Obese Adults: a 12-month Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Change in intrahepatic fat content
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 6-month follow-up study of TREATY-FLD trial to evaluate the effect of time restricted feeding (TRF) on hepatic fat contents and cardiometabolic risk factors in obese adults over 6 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
- •Man or women aged≥18 years;
- •Subjects with NAFLD determined by MRI (intrahepatic triglyceride content ≥5%);
- •Body mass index (BMI)of 28.0 to 45.0 kg/m2;
排除标准
- •History of alcoholic liver disease, chronic viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, cirrhosis, and liver cancer;
- •History of HIV, 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);
- •Significant alcohol consumption in the past six months (Consumed more than 20 g/day for women or 30 g/day for men);
- •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
Time Restricted Feeding
Participants will receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women during a window of 8 h/d (8 am to 4 pm).
干预措施: Time restricted feeding (Behavioral)
Continuous Energy Restriction
Participants will follow receive a diet of 1500-1800kcal/ d for men and 1200-1500kcal/d for women, without restriction on feeding time.
干预措施: Continuous Energy Restriction (Behavioral)
结局指标
主要结局
Change in intrahepatic fat content
时间窗: Baseline,month 6, month 12.
Intrahepatic fat content will be assessed by MR mDixon-Quant
次要结局
- Change in liver fiber(Baseline,month 6, month 12.)
- Change in body fat(Baseline,month 6, month 12.)
- Change in waist circumference(Baseline,month 6, month 12.)
- Change in HbA1c level(Baseline,month 6, month 12.)
- Change in serum ALT level(Baseline,month 6, month 12.)
- Change in visceral fat(Baseline,month 6, month 12.)
- Change in body weight(Baseline,month 6, month 12.)
- Change in Systolic blood pressure(Baseline,month 6, month 12.)
- Change in LDL-c level(Baseline,month 6, month 12.)
- Change in insulin sensitivity(Baseline,month 6, month 12.)
研究者
Huijie Zhang
Deputy director of Department of Endocrinology and Metabolism
Nanfang Hospital, Southern Medical University