Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-01-01 @ 12:41 AM
Study NCT ID:
NCT04707651
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2021-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Formula Diet Treatment for NASH Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D005234', 'term': 'Fatty Liver'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005526', 'term': 'Food, Formulated'}], 'ancestors': [{'id': 'D019648', 'term': 'Foods, Specialized'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Lifestyle intervention including formula diet'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-10', 'studyFirstSubmitDate': '2021-01-11', 'studyFirstSubmitQcDate': '2021-01-11', 'lastUpdatePostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'degree of steatosis', 'timeFrame': '12 weeks', 'description': 'degree of steatosis in decibels per meter (dB/m) measured by Controlled Attenuation Parameter (CAP) estimation'}], 'secondaryOutcomes': [{'measure': 'degree of steatosis', 'timeFrame': '52 weeks', 'description': 'degree of steatosis in decibels per meter (dB/m) measured by Controlled Attenuation Parameter (CAP) estimation'}, {'measure': 'degree of fibrosis', 'timeFrame': '12 weeks and 52 weeks', 'description': 'degree of fibrosis in meter per second (m/s) measured by Acoustic Radiation Force Impulse (ARFI) elastography'}, {'measure': 'fat mass', 'timeFrame': '12 weeks and 52 weeks', 'description': 'fatt mass in kilogram (kg) measured by Bioelectrical Impedance Analysis (BIA)'}, {'measure': 'Glutamate Pyruvate Transaminase (GPT)', 'timeFrame': '12 weeks and 52 weeks', 'description': 'Glutamate Pyruvate Transaminase in units/litre (U/L)'}, {'measure': 'Gamma-glutamyltransferase (GGT)', 'timeFrame': '12 weeks and 52 weeks', 'description': 'Gamma-glutamyltransferase in units/litre (U/L)'}, {'measure': 'insulin', 'timeFrame': '12 weeks and 52 weeks', 'description': 'insulin in micro units per millilitre (µU/ml)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['overweight', 'fatty liver'], 'conditions': ['Steatohepatitis, Nonalcoholic']}, 'descriptionModule': {'briefSummary': 'Non-alcoholic steatohepatitis (NASH) - also called fatty liver - is medically a serious problem because the liver tissue becomes fatty and stiff, and inflammatory reactions occur. This increases the risk of liver fibrosis (= scarring of the liver), liver cirrhosis (= shrunken liver), a liver tumor or death. So far there is no recognized treatment option for this disease. However, there is evidence that a lifestyle change based on a reduced carbohydrate diet, more exercise and a significant weight loss that can improve NASH.', 'detailedDescription': 'Outpatients with NASH will be included into this lifestyle intervention study. Patients will get nutritional advices and a formula diet for 12 weeks. Clinical visits will take place at baseline, after 4, 12 and after 52 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI\\>25 kg/qm\n\nExclusion Criteria:\n\n* history of drug or alcohol abuse\n* acute or chronic diseases (except type 2 diabetes)\n* pregnancy or breast feeding'}, 'identificationModule': {'nctId': 'NCT04707651', 'acronym': 'NASH', 'briefTitle': 'Formula Diet Treatment for NASH Patients.', 'organization': {'class': 'OTHER', 'fullName': 'West German Center of Diabetes and Health'}, 'officialTitle': 'Formula Diet Treatment for Weight Reduction in NASH Patients.', 'orgStudyIdInfo': {'id': 'NASH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle intervention', 'description': 'Nutrition advices and formula diet', 'interventionNames': ['Dietary Supplement: Formula diet']}], 'interventions': [{'name': 'Formula diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Formula diet for 12 weeks', 'armGroupLabels': ['Lifestyle intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40591', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'Düsseldorf Catholic Hospital Group', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '42283', 'city': 'Wuppertal', 'country': 'Germany', 'facility': 'Praxis Prof. Erhardt', 'geoPoint': {'lat': 51.25627, 'lon': 7.14816}}], 'overallOfficials': [{'name': 'Stephan Martin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West-German Centre of Diabetes and Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West German Center of Diabetes and Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Stephan Martin', 'investigatorAffiliation': 'West German Center of Diabetes and Health'}}}}