Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-10 @ 8:52 PM
Study NCT ID:
NCT05579158
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2022-10-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Time-restricted Eating Supported by Mobile Technology in Patients With Non-alcoholic Fatty Liver Disease: Randomized Controlled Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D000093763', 'term': 'Intermittent Fasting'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005215', 'term': 'Fasting'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000076251', 'term': 'Wearable Electronic Devices'}], 'ancestors': [{'id': 'D055615', 'term': 'Electrical Equipment and Supplies'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 337}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-22', 'studyFirstSubmitDate': '2022-10-10', 'studyFirstSubmitQcDate': '2022-10-11', 'lastUpdatePostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in hepatic steatosis (%)', 'timeFrame': '16 weeks', 'description': 'Change in hepatic steatosis (%) on Magnetic Resonance Imaging (MRI) Proton Density Fat fraction (PDFF) of the Liver'}], 'secondaryOutcomes': [{'measure': 'Change in 10-year atherosclerotic cardiovascular disease (ASCVD) risk', 'timeFrame': '16 weeks', 'description': 'Evaluate the mean change in atherosclerotic cardiovascular disease (ASCVD) risk score (%) (high ASCVD risk score means high risk of ASCVD)'}, {'measure': 'Change in liver fibrosis (kPa) by Magnetic Resonance Elastography (MRE)', 'timeFrame': '16 weeks', 'description': 'Evaluate the mean change in liver fibrosis (kPa) on Magnetic Resonance Elastography (MRE) of the Liver'}, {'measure': 'Change in body weight (kg)', 'timeFrame': '16 weeks', 'description': 'Evaluate the mean change in body weight (kg)'}, {'measure': 'Change in systolic blood pressure (mmHg)', 'timeFrame': '16 weeks', 'description': 'Evaluate the mean change in systolic blood pressure (mmHg)'}, {'measure': 'Change in low-density lipoprotein level (mg/dL)', 'timeFrame': '16 weeks', 'description': 'Evaluate the mean change in low-density lipoprotein level (mg/dL)'}, {'measure': 'Change in serum alanine aminotransferase level (IU/L)', 'timeFrame': '16 weeks', 'description': 'Evaluate the mean change in serum alanine aminotransferase level (IU/L)'}, {'measure': 'Change in hemoglobin A1c level (%)', 'timeFrame': '16 weeks', 'description': 'Evaluate the mean change in hemoglobin A1c level (%)'}, {'measure': 'Change in insulin sensitivity', 'timeFrame': '16 weeks', 'description': 'Evaluate the mean change in homeostatic model assessment for insulin resistance (HOMA-IR)'}, {'measure': 'Change in urine microalbumin (mcg/min)', 'timeFrame': '16 weeks', 'description': 'Evaluate the mean change in urine microalbumin (mcg/min)'}, {'measure': 'Change in body muscle mass (kg)', 'timeFrame': '16 weeks', 'description': 'Evaluate the mean change in body muscle mass (kg) as measured by bioelectrical impedance analysis (InBody)'}, {'measure': 'Change in liver fibrosis by liver stiffness (kPa)', 'timeFrame': '16 weeks', 'description': 'Evaluate the mean change in liver fibrosis by liver stiffness (kPa) under FibroScan®'}, {'measure': 'Change in liver steatosis by controlled attenuation parameter (dB/m)', 'timeFrame': '16 weeks', 'description': 'Evaluate the mean change in liver steatosis by controlled attenuation parameter (dB/m) under FibroScan®'}, {'measure': 'Change in body weight (kg) at 6 months after the intervention', 'timeFrame': '40 weeks', 'description': 'Evaluate the mean change in body weight (kg) at 24 weeks after the end of 16-week intervention period'}, {'measure': 'Change in body weight (kg) at 12 months after the intervention', 'timeFrame': '64 weeks', 'description': 'Evaluate the mean change in body weight (kg) at 48 weeks after the end of 16-week intervention period'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-Alcoholic Fatty Liver Disease', 'Time Restricted Feeding', 'Mobile Technology']}, 'referencesModule': {'references': [{'pmid': '40543603', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥ 19 years who are willing and able to complete all procedures\n* Hepatic steatosis by imaging (ultrasound, computed tomography, magnetic resonance imaging, and controlled attenuation parameter (≥260 dB/m))\n\nExclusion Criteria:\n\n* Body mass index (BMI) \\<23\n* Other causes of chronic liver disease (HBV, HCV), autoimmune diseases or chronic cholestatic liver disease\n* 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)\n* Significant alcohol intake (\\>210g/week for men, \\>140g/week for women)\n* Severe medical comorbidities (ischemic heart disease, 3rd degree atrioventricular block, chronic obstructive pulmonary disease, severe hypertension (blood pressure \\> 200/120 mmHg)\n* Psychiatric illnesses which limit ability to exercise safely\n* Diagnosed with diabetes on medication or insulin\n* Participation in a weight-loss program within 12 weeks\n* MRI contraindications'}, 'identificationModule': {'nctId': 'NCT05579158', 'briefTitle': 'Effects of Time-restricted Eating Supported by Mobile Technology in Patients With Non-alcoholic Fatty Liver Disease: Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Hanyang University'}, 'officialTitle': 'Effects of Time-restricted Eating Supported by Mobile Technology in Patients With Non-alcoholic Fatty Liver Disease: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HanyangU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mobile application-supported both calorie restriction and time-restricted eating (mCR/TRE)', 'description': '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).', 'interventionNames': ['Behavioral: Mobile application and wearable device', 'Behavioral: Time-restricted eating']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mobile application-supported calorie restriction (mCR)', 'description': '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).', 'interventionNames': ['Behavioral: Mobile application and wearable device']}, {'type': 'NO_INTERVENTION', 'label': 'Calorie restriction (CR)', 'description': 'Standard of care. This arm receives a brief counseling of calorie restriction.'}], 'interventions': [{'name': 'Mobile application and wearable device', 'type': 'BEHAVIORAL', 'description': 'Mobile application-supported nutritional counseling includes education, monitoring, interaction, and physical activity', 'armGroupLabels': ['Mobile application-supported both calorie restriction and time-restricted eating (mCR/TRE)', 'Mobile application-supported calorie restriction (mCR)']}, {'name': 'Time-restricted eating', 'type': 'BEHAVIORAL', 'description': 'Time-restricted eating (an 8-hour period (from 10 a.m. to 6 p.m.) each day)', 'armGroupLabels': ['Mobile application-supported both calorie restriction and time-restricted eating (mCR/TRE)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '133792', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Hanyang University Seoul Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Dae Won Jun, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hanyang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanyang University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Health, Korea', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dae Won Jun', 'investigatorAffiliation': 'Hanyang University'}}}}