Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-01-21 @ 9:44 PM
Study NCT ID:
NCT02025920
Status:
COMPLETED
Last Update Posted:
2021-04-30
First Post:
2013-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Project Healthy Eating in Adults. A Study on the Health Effects of Fish Intake in Overweight Adults (FINS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-27', 'studyFirstSubmitDate': '2013-12-17', 'studyFirstSubmitQcDate': '2013-12-30', 'lastUpdatePostDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in metabolic status (glucose, lipids, inflammation)', 'timeFrame': 'Baseline and end of intervention (12 weeks)', 'description': 'The effects of fish intake on glucose homeostasis, lipid metabolism and inflammation will be assessed.'}], 'secondaryOutcomes': [{'measure': 'Changes in plasma concentrations of amino acids and their metabolites', 'timeFrame': 'Baseline and end of intervention (12 weeks)'}, {'measure': 'Changes in plasma concentrations of vitamins', 'timeFrame': 'Baseline and end of intervention (12 weeks)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Overweight or Obese Adults', 'Healthy']}, 'descriptionModule': {'briefSummary': 'It has previously been observed that increased fish intake improves the metabolic health of overweight and obese adults, and animal protein improved metabolic health of obese rats. In this project the investigators will investigate whether increased intake of fish or meat improves metabolic health in overweight/obese adults aged 20-55 years when replacing processed food. The hypothesis is that increased intake of unprocessed fish or meat will improve metabolic health in adults as measured by glucose tolerance, lipid metabolism and inflammatory markers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\> 27\n* 20-55 years\n* healthy\n\nExclusion Criteria:\n\n* diagnosed diseases such as diabetes, CVD, intestinal diseases, arthritis\n* prescription medications affecting the metabolism of glucose, lipids or the immune system\n* use of supplements containing long chain n-3 fatty acids\n* high intake of fish\n* food allergy'}, 'identificationModule': {'nctId': 'NCT02025920', 'briefTitle': 'Project Healthy Eating in Adults. A Study on the Health Effects of Fish Intake in Overweight Adults (FINS)', 'organization': {'class': 'OTHER', 'fullName': 'University of Bergen'}, 'officialTitle': 'Title in Norwegian: Sunn og Frisk. En Studie av Helseeffekter av Fiskeinntak i Overvektige Voksne (FINS)', 'orgStudyIdInfo': {'id': '2013/558'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Salmon Group', 'description': 'Participants will eat 150g salmon for dinner, 3 times per week for 12 weeks', 'interventionNames': ['Other: Salmon Group']}, {'type': 'EXPERIMENTAL', 'label': 'Cod Group', 'description': 'Participants will eat 150g cod for dinner, 3 times per week for 12 weeks', 'interventionNames': ['Other: Cod Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Meat Group', 'description': 'Participants will eat 150g mixed meat for dinner, 3 times per week for 12 weeks', 'interventionNames': ['Other: Meat Group']}], 'interventions': [{'name': 'Salmon Group', 'type': 'OTHER', 'armGroupLabels': ['Salmon Group']}, {'name': 'Cod Group', 'type': 'OTHER', 'armGroupLabels': ['Cod Group']}, {'name': 'Meat Group', 'type': 'OTHER', 'armGroupLabels': ['Meat Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bergen', 'country': 'Norway', 'facility': 'University of Bergen', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}], 'overallOfficials': [{'name': 'Oddrun A Gudbrandsen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bergen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bergen', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Fisheries and Aquaculture Industry Research Fund', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Researcher', 'investigatorFullName': 'Oddrun Anita Gudbrandsen', 'investigatorAffiliation': 'University of Bergen'}}}}