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| Name | Class |
|---|---|
| National Institute of Health, Korea | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile application-supported both calorie restriction and time-restricted eating (mCR/TRE) | Experimental | 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) | Active Comparator | 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). |
|
| Calorie restriction (CR) | No Intervention | Standard of care. This arm receives a brief counseling of calorie restriction. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile application and wearable device | Behavioral | Mobile application-supported nutritional counseling includes education, monitoring, interaction, and physical activity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in hepatic steatosis (%) | Change in hepatic steatosis (%) on Magnetic Resonance Imaging (MRI) Proton Density Fat fraction (PDFF) of the Liver | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 16 weeks |
| Change in liver fibrosis (kPa) by Magnetic Resonance Elastography (MRE) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dae Won Jun, M.D., Ph.D. | Hanyang University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hanyang University Seoul Hospital | Seoul | 133792 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40543603 | Derived | Oh JH, Yoon EL, Park H, Lee S, Jo AJ, Cho S, Kwon E, Nah EH, Lee JH, Park JH, Ahn SB, Jun DW. Efficacy and safety of time-restricted eating in metabolic dysfunction-associated steatotic liver disease. J Hepatol. 2025 Dec;83(6):1256-1265. doi: 10.1016/j.jhep.2025.06.005. Epub 2025 Jun 19. |
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| Time-restricted eating | Behavioral | Time-restricted eating (an 8-hour period (from 10 a.m. to 6 p.m.) each day) |
|
Evaluate the mean change in liver fibrosis (kPa) on Magnetic Resonance Elastography (MRE) of the Liver |
| 16 weeks |
| Change in body weight (kg) | Evaluate the mean change in body weight (kg) | 16 weeks |
| Change in systolic blood pressure (mmHg) | Evaluate the mean change in systolic blood pressure (mmHg) | 16 weeks |
| Change in low-density lipoprotein level (mg/dL) | Evaluate the mean change in low-density lipoprotein level (mg/dL) | 16 weeks |
| Change in serum alanine aminotransferase level (IU/L) | Evaluate the mean change in serum alanine aminotransferase level (IU/L) | 16 weeks |
| Change in hemoglobin A1c level (%) | Evaluate the mean change in hemoglobin A1c level (%) | 16 weeks |
| Change in insulin sensitivity | Evaluate the mean change in homeostatic model assessment for insulin resistance (HOMA-IR) | 16 weeks |
| Change in urine microalbumin (mcg/min) | Evaluate the mean change in urine microalbumin (mcg/min) | 16 weeks |
| Change in body muscle mass (kg) | Evaluate the mean change in body muscle mass (kg) as measured by bioelectrical impedance analysis (InBody) | 16 weeks |
| Change in liver fibrosis by liver stiffness (kPa) | Evaluate the mean change in liver fibrosis by liver stiffness (kPa) under FibroScan® | 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® | 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 | 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 | 64 weeks |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000076251 | Wearable Electronic Devices |
| ID | Term |
|---|---|
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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