NCT04988230已完成不适用
Effects of Time-Restricted Feeding on Nonalcoholic Fatty Liver Disease in Obese Adults: a 12-month Randomized Clinical Trial
适应症
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.
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 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 liver fiber(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
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Time Restricted Feeding on Nonalcoholic Fatty Liver DiseaseNonalcoholic Fatty Liver DiseaseNCT03786523Nanfang Hospital, Southern Medical University88
已完成
不适用
Time Restricted Feeding on Weight Loss and Cardio-protection (TREATY Trial)Time Restricted FeedingWeight LossCalorie RestrictionObesityNCT03745612Nanfang Hospital, Southern Medical University139
已完成
不适用
Effect of Time-Restricted Feeding on Fat Loss and Cardiometabolic Risk Factors in Overweight AdultsObesityNCT03459703University of Alabama at Birmingham90
已完成
不适用
Time Restricted Feeding for Weight Loss and Cardio-protectionCoronary DiseaseWeight LossNCT02948517University of Illinois at Chicago31
已完成
不适用
The Impact of Time Restricted Feeding (TRF) in Improving the Health of Patients With Metabolic SyndromeWeight LossMetabolic SyndromeOverweight and ObesityNCT03182985University of California, San Diego35