Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-03-07 @ 5:12 PM
Study NCT ID:
NCT02025933
Status:
TERMINATED
Last Update Posted:
2016-05-24
First Post:
2013-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Project Healthy Eating in Children. A Study on the Health Effects of Fish Intake in Overweight Children
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood for DNA analysis'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'We were unable to recruit a sufficient number of participants', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-22', 'studyFirstSubmitDate': '2013-12-17', 'studyFirstSubmitQcDate': '2013-12-30', 'lastUpdatePostDateStruct': {'date': '2016-05-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in metabolic status (glucose, lipids, inflammation)', 'timeFrame': 'Baseline and end of intervention period (12 weeks)', 'description': 'We will investigate any changes in the metabolic status by analyzing parameters affected by changes in glucose homeostasis, lipid metabolism and inflammation.'}], 'secondaryOutcomes': [{'measure': 'Body composition', 'timeFrame': 'Baseline and end of intervention (12 weeks)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Children', 'Age 9-12 years', 'Overweight (iso-BMI > 25)'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'It has previously been seen 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 improve metabolic health in children aged 9-12 years as well when replacing processed food. The hypothesis is that increased intake of unprocessed fish or meat will improve metabolic health in children as measured by glucose tolerance, lipid metabolism and inflammatory markers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '9 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Cildren aged 9-12 years are invited to participate in the study. The children must be healthy and not use prescription medications that affects lipid metabolism, glucose regulation or the immunesystem.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* overweight (iso-BMI \\> 25)\n* 9-12 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': 'NCT02025933', 'briefTitle': 'Project Healthy Eating in Children. A Study on the Health Effects of Fish Intake in Overweight Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Bergen'}, 'officialTitle': 'Title in Norwegian: Ung og Frisk. En Studie av Helseeffekter av Fiskeinntak i Overvektige Barn.', 'orgStudyIdInfo': {'id': '2013/541'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Salmon Group', 'description': 'Participants will eat 75 - 150 grams of salmon for dinner, three times a week for 12 weeks.', 'interventionNames': ['Other: Salmon Group']}, {'label': 'Cod Group', 'description': 'Participants will eat 75-150 grams of cod for dinner, three times a week for 12 weeks.', 'interventionNames': ['Other: Cod Group']}, {'label': 'Meat Group', 'description': 'Participants will eat 75-150 grams of mixed meat for dinner, three times a week for 12 weeks.', 'interventionNames': ['Other: Meat Group']}], 'interventions': [{'name': 'Salmon Group', 'type': 'OTHER', 'description': 'The children are advised to eat at least 75g of salmon per serving, but no more than 150g', 'armGroupLabels': ['Salmon Group']}, {'name': 'Cod Group', 'type': 'OTHER', 'description': 'The children are advised to eat at least 75g of cod per serving, but no more than 150g', 'armGroupLabels': ['Cod Group']}, {'name': 'Meat Group', 'type': 'OTHER', 'description': 'The children are advised to eat at least 75g of meat per serving, but no more than 150g', 'armGroupLabels': ['Meat Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5021', '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'}}}}