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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
337
Mobile application-supported nutritional counseling includes education, monitoring, interaction, and physical activity
Time-restricted eating (an 8-hour period (from 10 a.m. to 6 p.m.) each day)
Hanyang University Seoul Hospital
Seoul, South Korea
Change in hepatic steatosis (%)
Change in hepatic steatosis (%) on Magnetic Resonance Imaging (MRI) Proton Density Fat fraction (PDFF) of the Liver
Time frame: 16 weeks
Change in 10-year atherosclerotic cardiovascular disease (ASCVD) risk
Evaluate the mean change in atherosclerotic cardiovascular disease (ASCVD) risk score (%) (high ASCVD risk score means high risk of ASCVD)
Time frame: 16 weeks
Change in liver fibrosis (kPa) by Magnetic Resonance Elastography (MRE)
Evaluate the mean change in liver fibrosis (kPa) on Magnetic Resonance Elastography (MRE) of the Liver
Time frame: 16 weeks
Change in body weight (kg)
Evaluate the mean change in body weight (kg)
Time frame: 16 weeks
Change in systolic blood pressure (mmHg)
Evaluate the mean change in systolic blood pressure (mmHg)
Time frame: 16 weeks
Change in low-density lipoprotein level (mg/dL)
Evaluate the mean change in low-density lipoprotein level (mg/dL)
Time frame: 16 weeks
Change in serum alanine aminotransferase level (IU/L)
Evaluate the mean change in serum alanine aminotransferase level (IU/L)
Time frame: 16 weeks
Change in hemoglobin A1c level (%)
Evaluate the mean change in hemoglobin A1c level (%)
Time frame: 16 weeks
Change in insulin sensitivity
Evaluate the mean change in homeostatic model assessment for insulin resistance (HOMA-IR)
Time frame: 16 weeks
Change in urine microalbumin (mcg/min)
Evaluate the mean change in urine microalbumin (mcg/min)
Time frame: 16 weeks
Change in body muscle mass (kg)
Evaluate the mean change in body muscle mass (kg) as measured by bioelectrical impedance analysis (InBody)
Time frame: 16 weeks
Change in liver fibrosis by liver stiffness (kPa)
Evaluate the mean change in liver fibrosis by liver stiffness (kPa) under FibroScan®
Time frame: 16 weeks
Change in liver steatosis by controlled attenuation parameter (dB/m)
Evaluate the mean change in liver steatosis by controlled attenuation parameter (dB/m) under FibroScan®
Time frame: 16 weeks
Change in body weight (kg) at 6 months after the intervention
Evaluate the mean change in body weight (kg) at 24 weeks after the end of 16-week intervention period
Time frame: 40 weeks
Change in body weight (kg) at 12 months after the intervention
Evaluate the mean change in body weight (kg) at 48 weeks after the end of 16-week intervention period
Time frame: 64 weeks
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