Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2025-12-31 @ 3:52 PM
Study NCT ID:
NCT04066400
Status:
COMPLETED
Last Update Posted:
2023-12-28
First Post:
2019-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of a Wheat Containing Diet on Non-alcoholic Steatohepatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'randomization'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective, randomized, controlled, bicentric pilot study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-27', 'studyFirstSubmitDate': '2019-08-17', 'studyFirstSubmitQcDate': '2019-08-22', 'lastUpdatePostDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of ATI-free Nutrition on hepatic inflammation', 'timeFrame': '16 weeks', 'description': 'Reduction of Alanine-Aminotransferase (ALT; U/ml) compared to baseline'}], 'secondaryOutcomes': [{'measure': 'Quality of Life using the chronic liver disease questionnaire (CLDQ)', 'timeFrame': '16 weeks', 'description': 'The CLDQ is a validated patient-reported outcome measure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hepatic inflammation'], 'conditions': ['NASH - Nonalcoholic Steatohepatitis', 'Diabetes Mellitus, Type 2', 'Hyperlipidemias']}, 'referencesModule': {'references': [{'pmid': '38462919', 'type': 'DERIVED', 'citation': 'Armandi A, Bespaljko H, Mang A, Huber Y, Michel M, Labenz C, Galle PR, Neerukonda M, Bugianesi E, Schuppan D, Schattenberg JM. Short-term reduction of dietary gluten improves metabolic-dysfunction associated steatotic liver disease: A randomised, controlled proof-of-concept study. Aliment Pharmacol Ther. 2024 May;59(10):1212-1222. doi: 10.1111/apt.17941. Epub 2024 Mar 11.'}]}, 'descriptionModule': {'briefSummary': 'Effects of Wheat-based diet vs. ATI-free diet on NASH', 'detailedDescription': '40 patients with the diagnosis of a non-alcoholic- steatohepatitis (NASH) will be recruited at the University Hospitals of Mainz and Frankfurt. Patients are assessed with regards to their diet using standardized questionnaire and nutritionists.\n\nPatients will be randomized into two parallel groups. The first group will continue a wheat-based Nutrition, while the second Group will receive dietary counselling to achieve an ATI-free nutrition, trying to reduce the daily ATI consumption.\n\nThe clinical trial will run over 16 weeks including 4 visits at the study center. Study visits include physical examinations, blood-based parameters, cytokines and urine samples, as well for the analysis of the intestinal microbiome by using stool samples. In addition the patients have to complete dietary and health-related quality of life (HRQL) questionnaires. Visits are planned at baseline, W4, W8 and W16.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically proven NASH in the past 36 months with increased ALT: males: \\>60, females: \\>42 U/ml\n* no body weight modification about \\>10% in the past 24 weeks\n* no new drugs treating parts of the metabolic syndrome in the past 12 weeks\n* for patients with Diabetes: HbA1c value \\<8,6%\n* the ability to understand the aim and the possible individual consequences of this Trial\n* signed and dated consent before the Trial starts\n\nExclusion Criteria:\n\n* unstable coronary heart disease, stroke in the past 6 months\n* different liver diseases\n* proceeded fibrosis (Fibroscan \\>9,6 kPA) or histological cirrhosis\n* hepatocellular carcinoma or not curative treated carcinomas\n* alcohol consumption \\>10g/day (females), \\>20g/day (males)\n* gravidity\n* drugs causing secondary NASH (e.g. Tamoxifen, corticosteroids)\n* immunological or inflammatory diseases (e.g. systemic Lupus erythematodes)\n* warfarin therapy\n* implementation of another Special diet'}, 'identificationModule': {'nctId': 'NCT04066400', 'acronym': 'NASH-ATI', 'briefTitle': 'Role of a Wheat Containing Diet on Non-alcoholic Steatohepatitis', 'organization': {'class': 'OTHER', 'fullName': 'Johannes Gutenberg University Mainz'}, 'officialTitle': 'Role of a Wheat-based Diet in NASH (NASH-ATI)', 'orgStudyIdInfo': {'id': '2018-13078'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'wheat-based diet', 'description': 'The patients continue a wheat-based diet aiming at a reduction in bodyweight.', 'interventionNames': ['Other: Nutritional Intervention']}, {'type': 'EXPERIMENTAL', 'label': 'ATI reduced diet', 'description': 'Patients are counselled to reduce dietary gluten uptake.', 'interventionNames': ['Other: Nutritional Intervention']}], 'interventions': [{'name': 'Nutritional Intervention', 'type': 'OTHER', 'description': 'Dietary Counselling', 'armGroupLabels': ['ATI reduced diet', 'wheat-based diet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Universität Frankfurt', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Mainz', 'country': 'Germany', 'facility': 'University Medical Center Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johannes Gutenberg University Mainz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Goethe University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Metabolic Liver Disease Program', 'investigatorFullName': 'Jörn M. Schattenberg', 'investigatorAffiliation': 'Johannes Gutenberg University Mainz'}}}}