Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 8:24 AM
Study NCT ID:
NCT01092793
Status:
COMPLETED
Last Update Posted:
2023-12-06
First Post:
2010-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Superba Krill on Inflammation in Patients With Coronary Artery Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C058429', 'term': 'krill protein extract'}, {'id': 'D005395', 'term': 'Fish Oils'}], 'ancestors': [{'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-29', 'studyFirstSubmitDate': '2010-03-23', 'studyFirstSubmitQcDate': '2010-03-23', 'lastUpdatePostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inflammatory blood status', 'timeFrame': '8 weeks intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fish oil', 'Krill', 'CAD'], 'conditions': ['Stable Atherosclerotic Coronary Disease']}, 'descriptionModule': {'briefSummary': 'Atherosclerotic coronary heart disease is a condition thought to involve low-grade inflammation. Several reports, clinical and epidemiological, have demonstrated that intake of fish oil may be beneficial in attenuating the inflammatory process. Still, however, there are lacking data in respect to whether differences in composition of various marine oils may influence the inflammatory status differently.\n\nThe hypothesis of the current study is that extract from the antarctic krill (Euphausia superba) is better than traditional fish oils when compared head-to-head with balanced composition of omega 3 content on inflammatory status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 18-80 years\n* Sex: Male and female\n* Stable atherosclerotic coronary heart disease (heart attack \\>3 months ago or objectified angina pectoris).\n* No hospitalization for heart disease last 3 months.\n\nExclusion Criteria:\n\n* Unstable heart disease.\n* Heart failure NYHA class III and IV.\n* Previous valve and/or aortic surgery\n* Significant concomitant disease (i.e. diseases with known inflammatory activation - e.g. various autoimmune diseases, chronic infections, significant acute infections three weeks before or during the study, connective tissue disease, arthritis, chronic pulmonary disease or serious liver- or kidney-disease).\n* Simultaneous involvement in other clinical studies involving intervention.\n* Planned operation or other invasive procedures (e.g. PCI etc.) during the study period.'}, 'identificationModule': {'nctId': 'NCT01092793', 'briefTitle': 'Effect of Superba Krill on Inflammation in Patients With Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Effect of Superba Krill on Inflammation in Patients With Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'Krill-2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Krill', 'interventionNames': ['Dietary Supplement: Krill']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fish oil', 'interventionNames': ['Dietary Supplement: Fish oil']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Krill', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Encapsulated oil from the antarctic crustacean Krill', 'armGroupLabels': ['Krill']}, {'name': 'Fish oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Encapsulated, raffined cod-oil', 'armGroupLabels': ['Fish oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0027', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Department of Cardiology, Oslo University Hospital / Rikshospitalet', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}