Effects of Time-restricted Eating Supported by Mobile Technology in Patients With Non-alcoholic Fatty Liver Disease: Randomized Controlled Trial
- Conditions
- Time Restricted FeedingMobile TechnologyNon-Alcoholic Fatty Liver Disease
- Interventions
- Behavioral: Mobile application and wearable deviceBehavioral: Time-restricted eating
- Registration Number
- NCT05579158
- Lead Sponsor
- Hanyang University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 337
- 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))
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mobile application-supported both calorie restriction and time-restricted eating (mCR/TRE) Mobile application and wearable device 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). Mobile application-supported both calorie restriction and time-restricted eating (mCR/TRE) Time-restricted eating 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). Mobile application-supported calorie restriction (mCR) Mobile application and wearable device 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).
- Primary Outcome Measures
Name Time Method Change in hepatic steatosis (%) 16 weeks Change in hepatic steatosis (%) on Magnetic Resonance Imaging (MRI) Proton Density Fat fraction (PDFF) of the Liver
- Secondary Outcome Measures
Name Time Method Change in hemoglobin A1c level (%) 16 weeks Evaluate the mean change in hemoglobin A1c level (%)
Change in body weight (kg) at 6 months after the intervention 40 weeks Evaluate the mean change in body weight (kg) at 24 weeks after the end of 16-week intervention period
Change in urine microalbumin (mcg/min) 16 weeks Evaluate the mean change in urine microalbumin (mcg/min)
Change in liver fibrosis by liver stiffness (kPa) 16 weeks Evaluate the mean change in liver fibrosis by liver stiffness (kPa) under FibroScan®
Change in body muscle mass (kg) 16 weeks Evaluate the mean change in body muscle mass (kg) as measured by bioelectrical impedance analysis (InBody)
Change in 10-year atherosclerotic cardiovascular disease (ASCVD) risk 16 weeks Evaluate the mean change in atherosclerotic cardiovascular disease (ASCVD) risk score (%) (high ASCVD risk score means high risk of ASCVD)
Change in insulin sensitivity 16 weeks Evaluate the mean change in homeostatic model assessment for insulin resistance (HOMA-IR)
Change in body weight (kg) 16 weeks Evaluate the mean change in body weight (kg)
Change in systolic blood pressure (mmHg) 16 weeks Evaluate the mean change in systolic blood pressure (mmHg)
Change in serum alanine aminotransferase level (IU/L) 16 weeks Evaluate the mean change in serum alanine aminotransferase level (IU/L)
Change in body weight (kg) at 12 months after the intervention 64 weeks Evaluate the mean change in body weight (kg) at 48 weeks after the end of 16-week intervention period
Change in liver fibrosis (kPa) by Magnetic Resonance Elastography (MRE) 16 weeks Evaluate the mean change in liver fibrosis (kPa) on Magnetic Resonance Elastography (MRE) of the Liver
Change in low-density lipoprotein level (mg/dL) 16 weeks Evaluate the mean change in low-density lipoprotein level (mg/dL)
Change in liver steatosis by controlled attenuation parameter (dB/m) 16 weeks Evaluate the mean change in liver steatosis by controlled attenuation parameter (dB/m) under FibroScan®
Trial Locations
- Locations (1)
Hanyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of