Effects of Time-restricted Eating Supported by Mobile Technology in Patients With Non-alcoholic Fatty Liver Disease: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 337
- 试验地点
- 1
- 主要终点
- Change in hepatic steatosis (%)
研究概览
简要总结
In non-alcoholic fatty liver disease (NAFLD), it is established that calorie restriction is the most essential dietary modification. The time-restricted diet is successful lowering total calorie consumption and insulin resistance, and is anticipated to be beneficial for patients with NAFLD. Therefore, this study aims to conduct a prospective study to determine the effect of time-restricted diet via a mobile application on the amount of intrahepatic fat and 10-year cardiovascular disease risk in patients with NAFLD.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged ≥ 19 years who are willing and able to complete all procedures
- •Hepatic steatosis by imaging (ultrasound, computed tomography, magnetic resonance imaging, and controlled attenuation parameter (≥260 dB/m))
排除标准
- •Body mass index (BMI) <23
- •Other causes of chronic liver disease (HBV, HCV), autoimmune diseases or chronic cholestatic liver disease
- •Medications which cause liver disease or secondary hepatic steatosis (Tamoxifen, systemic corticosteroids, methotrexate, tetracycline, estrogens, valproic acid, and statin (registration is possible if statin is delivered in a consistent dosage within 12 weeks)
- •Significant alcohol intake (>210g/week for men, >140g/week for women)
- •Severe medical comorbidities (ischemic heart disease, 3rd degree atrioventricular block, chronic obstructive pulmonary disease, severe hypertension (blood pressure > 200/120 mmHg)
- •Psychiatric illnesses which limit ability to exercise safely
- •Diagnosed with diabetes on medication or insulin
- •Participation in a weight-loss program within 12 weeks
- •MRI contraindications
研究组 & 干预措施
Mobile application-supported both calorie restriction and time-restricted eating (mCR/TRE)
This arm receives wearable device and mobile application-supported nutritional counseling for four months. The nutritional counseling consists of both calorie restriction (500kcal below estimated energy requirement) and time-restricted eating (an 8-hour period (from 10 a.m. to 6 p.m.) each day).
干预措施: Mobile application and wearable device (Behavioral)
Mobile application-supported both calorie restriction and time-restricted eating (mCR/TRE)
This arm receives wearable device and mobile application-supported nutritional counseling for four months. The nutritional counseling consists of both calorie restriction (500kcal below estimated energy requirement) and time-restricted eating (an 8-hour period (from 10 a.m. to 6 p.m.) each day).
干预措施: Time-restricted eating (Behavioral)
Mobile application-supported calorie restriction (mCR)
This arm receives wearable device and mobile application-supported nutritional counseling for four months. The nutritional counseling consists of only calorie restriction (500kcal below estimated energy requirement).
干预措施: Mobile application and wearable device (Behavioral)
Calorie restriction (CR)
Standard of care. This arm receives a brief counseling of calorie restriction.
结局指标
主要结局
Change in hepatic steatosis (%)
时间窗: 16 weeks
Change in hepatic steatosis (%) on Magnetic Resonance Imaging (MRI) Proton Density Fat fraction (PDFF) of the Liver
次要结局
- Change in liver fibrosis by liver stiffness (kPa)(16 weeks)
- Change in urine microalbumin (mcg/min)(16 weeks)
- Change in body muscle mass (kg)(16 weeks)
- Change in 10-year atherosclerotic cardiovascular disease (ASCVD) risk(16 weeks)
- Change in hemoglobin A1c level (%)(16 weeks)
- Change in insulin sensitivity(16 weeks)
- Change in body weight (kg)(16 weeks)
- Change in systolic blood pressure (mmHg)(16 weeks)
- Change in serum alanine aminotransferase level (IU/L)(16 weeks)
- Change in body weight (kg) at 12 months after the intervention(64 weeks)
- Change in liver fibrosis (kPa) by Magnetic Resonance Elastography (MRE)(16 weeks)
- Change in low-density lipoprotein level (mg/dL)(16 weeks)
- Change in body weight (kg) at 6 months after the intervention(40 weeks)
- Change in liver steatosis by controlled attenuation parameter (dB/m)(16 weeks)