Mobile Technology, Non-Alcoholic Fatty Liver Disease, Time Restricted Feeding
Conditions
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.
Interventions
BEHAVIORALMobile application and wearable device
Mobile application-supported nutritional counseling includes education, monitoring, interaction, and physical activity
BEHAVIORALTime-restricted eating
Time-restricted eating (an 8-hour period (from 10 a.m. to 6 p.m.) each day)
Sponsors
National Institute of Health, Korea
Hanyang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hepatic steatosis (%) | 16 weeks | Change in hepatic steatosis (%) on Magnetic Resonance Imaging (MRI) Proton Density Fat fraction (PDFF) of the Liver |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in systolic blood pressure (mmHg) | 16 weeks | Evaluate the mean change in systolic blood pressure (mmHg) |
| 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 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 serum alanine aminotransferase level (IU/L) | 16 weeks | Evaluate the mean change in serum alanine aminotransferase level (IU/L) |
| Change in hemoglobin A1c level (%) | 16 weeks | Evaluate the mean change in hemoglobin A1c level (%) |
| Change in body weight (kg) | 16 weeks | Evaluate the mean change in body weight (kg) |
| Change in urine microalbumin (mcg/min) | 16 weeks | Evaluate the mean change in urine microalbumin (mcg/min) |
| 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 liver fibrosis by liver stiffness (kPa) | 16 weeks | Evaluate the mean change in liver fibrosis by liver stiffness (kPa) under FibroScan® |
| 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® |
| 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 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 insulin sensitivity | 16 weeks | Evaluate the mean change in homeostatic model assessment for insulin resistance (HOMA-IR) |
Countries
South Korea
Outcome results
None listed