Effects of Time-restricted Eating Supported by Mobile Technology in Patients With Non-alcoholic Fatty Liver Disease: Randomized Controlled Trial

Effects of Time-restricted Eating Supported by Mobile Technology in Patients With Non-alcoholic Fatty Liver Disease: Randomized Controlled Trial

Effects of Time-restricted Eating Supported by Mobile Technology in Patients With Non-alcoholic Fatty Liver Disease: Randomized Controlled Trial

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.

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).

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).

Mobile application-supported nutritional counseling includes education, monitoring, interaction, and physical activity

Change in hepatic steatosis (%) on Magnetic Resonance Imaging (MRI) Proton Density Fat fraction (PDFF) of the Liver

Evaluate the mean change in atherosclerotic cardiovascular disease (ASCVD) risk score (%) (high ASCVD risk score means high risk of ASCVD)

Evaluate the mean change in liver fibrosis (kPa) on Magnetic Resonance Elastography (MRE) of the Liver

Evaluate the mean change in body muscle mass (kg) as measured by bioelectrical impedance analysis (InBody)

Evaluate the mean change in liver steatosis by controlled attenuation parameter (dB/m) under FibroScan®

Evaluate the mean change in body weight (kg) at 24 weeks after the end of 16-week intervention period

Evaluate the mean change in body weight (kg) at 48 weeks after the end of 16-week intervention period

Inclusion Criteria: 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)) Exclusion Criteria: 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