Clinical trial NCT05579158: Effects of Time-restricted Eating Supported by Mobile Technology in Patients With Non-alcoholic Fatty Liver Disease: Randomized Controlled Trial
Official title: Effects of Time-restricted Eating Supported by Mobile Technology in Patients With Non-alcoholic Fatty Liver Disease: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Time Restricted Feeding
Mobile Technology
Lead sponsor: Hanyang University
Sponsor class: OTHER
Collaborators: name: National Institute of Health, Korea
First posted: 2022-10-13
Enrollment: 337
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in hepatic steatosis (%)
timeFrame: 16 weeks
Secondary outcomes:
measure: Change in 10-year atherosclerotic cardiovascular disease (ASCVD) risk
timeFrame: 16 weeks
measure: Change in liver fibrosis (kPa) by Magnetic Resonance Elastography (MRE)
timeFrame: 16 weeks
measure: Change in body weight (kg)
timeFrame: 16 weeks
measure: Change in systolic blood pressure (mmHg)
timeFrame: 16 weeks
measure: Change in low-density lipoprotein level (mg/dL)
timeFrame: 16 weeks
measure: Change in serum alanine aminotransferase level (IU/L)
timeFrame: 16 weeks
measure: Change in hemoglobin A1c level (%)
timeFrame: 16 weeks
measure: Change in insulin sensitivity
timeFrame: 16 weeks
measure: Change in urine microalbumin (mcg/min)
timeFrame: 16 weeks
measure: Change in body muscle mass (kg)
timeFrame: 16 weeks
measure: Change in liver fibrosis by liver stiffness (kPa)
timeFrame: 16 weeks
measure: Change in liver steatosis by controlled attenuation parameter (dB/m)
timeFrame: 16 weeks
measure: Change in body weight (kg) at 6 months after the intervention
timeFrame: 40 weeks
measure: Change in body weight (kg) at 12 months after the intervention
timeFrame: 64 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
Study officials:
affiliation: Hanyang University
name: Dae Won Jun, M.D., Ph.D.
role: STUDY_CHAIR
References: