Ignite Creation Date:
2025-12-24 @ 12:13 PM
Ignite Modification Date:
2026-01-24 @ 2:51 PM
Study NCT ID:
NCT03300661
Status:
COMPLETED
Last Update Posted:
2019-05-23
First Post:
2017-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non Alcoholic Fatty Liver Disease: Nutritional Epidemiology and Lifestyle Medicine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A single cohort of patients with NAFLD, without control group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-22', 'studyFirstSubmitDate': '2017-09-28', 'studyFirstSubmitQcDate': '2017-09-28', 'lastUpdatePostDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight loss', 'timeFrame': '12 months', 'description': 'A reduction of at least 3 Kg'}, {'measure': 'Body Mass Index (BMI) decrease', 'timeFrame': '12 months', 'description': 'A dicresae of at least 1Kg/m2'}, {'measure': 'Waist Circumference (WC) decrease', 'timeFrame': '12 months', 'description': 'A decrease of at least 1.5 cm'}], 'secondaryOutcomes': [{'measure': 'Blood sugar level decrease', 'timeFrame': '12 months', 'description': 'A decrease of 6 mg/dL'}, {'measure': 'Blood cholesterol level decrease', 'timeFrame': '12 months', 'description': 'A decrease of 9 mg/dL'}, {'measure': 'Blood triglycerides level dicrease', 'timeFrame': '12 months', 'description': 'A decrease of 12 mg/dL'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non Alcoholic Fatty Liver Disease', 'Lifestyle', 'Diet Modification']}, 'referencesModule': {'references': [{'pmid': '38303926', 'type': 'DERIVED', 'citation': 'Zanini B, Benini F, Marullo M, Simonetto A, Rossi A, Cavagnoli P, Bonalumi A, Marconi S, Pigozzi MG, Gilioli G, Valerio A, Donato F, Castellano M, Ricci C. Mediterranean-Oriented Dietary Intervention Is Effective to Reduce Liver Steatosis in Patients with Nonalcoholic Fatty Liver Disease: Results from an Italian Clinical Trial. Int J Clin Pract. 2024 Jan 25;2024:8861126. doi: 10.1155/2024/8861126. eCollection 2024.'}]}, 'descriptionModule': {'briefSummary': 'The study is an open-label intervention non pharmacological Cohort Study without control arm in patients with Non Alcoholic Fatty Liver Disease (NAFLD) and in healthy subjects.\n\nThe intervention in patients with NAFLD is educational, providing personalized suggestions to improve diet and physical activity; the intervention in healthy subjects is educational, providing general suggestions to improve diet and physical activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of Fatty Liver at ultrasonography\n\nExclusion Criteria:\n\n* Pregnancy;\n* Breast Feeding\n* Cirrhosis or End Stage Liver Disease\n* Fatty Liver due to Hepatic Diseases other than Non Alcoholic Fatty Liver disease\n* Concomitant severe clinical condition'}, 'identificationModule': {'nctId': 'NCT03300661', 'acronym': 'SEELN', 'briefTitle': 'Non Alcoholic Fatty Liver Disease: Nutritional Epidemiology and Lifestyle Medicine', 'organization': {'class': 'OTHER', 'fullName': 'Università degli Studi di Brescia'}, 'officialTitle': 'Open-label, Non-Pharmacological, Intervention Cohort Study Without Control Arm, in Patients With Non Alcoholic Fatty Liver Disease and in Healthy Subjects.', 'orgStudyIdInfo': {'id': 'Ubrescia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mediterranean Style', 'description': 'Educational intervention with personalized suggestions to improve diet and physical activity', 'interventionNames': ['Behavioral: Mediterranean Style']}], 'interventions': [{'name': 'Mediterranean Style', 'type': 'BEHAVIORAL', 'description': 'After completion of a Food Frequency Questinnaire (FFQ) and the International Physical Activity Questionnaire (IPAQ), patients enrolled in the study undergo a personalized educational intervention by a registered dietician. During the intervention the dietician advice about the main errors in diet and physical activity (by FFQ and IPAQ) and chooses three aims in diet modification and one aim in physical activity improvement. Patients adherence is assessed by the same dietician every three months, using FFQ and IPAQ, and futher supports are provided. Total intervention lenght is twelve months.', 'armGroupLabels': ['Mediterranean Style']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25123', 'city': 'Brescia', 'country': 'Italy', 'facility': 'ASST Spedali Civili Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}], 'overallOfficials': [{'name': 'Chiara Ricci, MD. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Università degli Studi di Brescia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Università degli Studi di Brescia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Chiara Ricci', 'investigatorAffiliation': 'Università degli Studi di Brescia'}}}}