Effects of Time-restricted Eating Supported by Mobile Technology in Patients With Non-alcoholic Fatty Liver Disease: Randomized Controlled Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mobile application-supported both calorie restriction and time-restricted eating (mCR/TRE) 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). |
Behavioral: Mobile application and wearable device
Mobile application-supported nutritional counseling includes education, monitoring, interaction, and physical activity
Behavioral: Time-restricted eating
Time-restricted eating (an 8-hour period (from 10 a.m. to 6 p.m.) each day)
|
| Active Comparator: Mobile application-supported calorie restriction (mCR) 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). |
Behavioral: Mobile application and wearable device
Mobile application-supported nutritional counseling includes education, monitoring, interaction, and physical activity
|
| No Intervention: Calorie restriction (CR) Standard of care. This arm receives a brief counseling of calorie restriction. |
Outcome Measures
Primary Outcome Measures
- 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
- 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 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 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 insulin sensitivity [16 weeks]
Evaluate the mean change in homeostatic model assessment for insulin resistance (HOMA-IR)
- 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®
Eligibility Criteria
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:
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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)
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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
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Diagnosed with diabetes on medication or insulin
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hanyang University Seoul Hospital | Seoul | Korea, Republic of | 133792 |
Sponsors and Collaborators
- Hanyang University
- National Institute of Health, Korea
Investigators
- Study Chair: Dae Won Jun, M.D., Ph.D., Hanyang University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HanyangU