Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-31 @ 9:52 AM
Study NCT ID:
NCT04768595
Status:
UNKNOWN
Last Update Posted:
2021-02-24
First Post:
2021-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Effect of Different Fish Oils on Omega-3 Index (CetoIndex)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Fish oil or placebo are given as gelatin capsules packaged in identical white bottles.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-22', 'studyFirstSubmitDate': '2021-02-18', 'studyFirstSubmitQcDate': '2021-02-22', 'lastUpdatePostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Omega-3 index', 'timeFrame': 'Baseline (supplementation start: time point 0) to 2 months of supplementation', 'description': 'Change in the omega-3 index (EPA and DHA content as a % of total fatty acids in red blood cells) from baseline to end of supplementation'}], 'secondaryOutcomes': [{'measure': 'Change in fatty acid profile from baseline to end of supplementation between study arms.', 'timeFrame': 'Baseline to 2 months of supplementation.', 'description': 'The secondary endpoint measures the fatty acid profiles from baseline to end of supplementation for each study arm. The results will then be compared between groups. Fatty acid profiles will be analyzed on whole blood samples using the Omega-quant test kit and analysis service. Changes in the analyzed fatty acids are determined from statistical assessment of whole blood analysis. The fatty acid profile is an exploratory endpoint.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The study determines the EPA DHA uptake from different omega-3 supplements against a control.', 'detailedDescription': 'The chronic uptake of omega-3 fatty acids EPA and DHA are commonly determined by measurement of EPA and DHA in red bloods cells and presented as a % of total fatty acids, the so-called Omega-3 Index. The index is a validated risk assessment for cardiovascular disease. Different fish oils may influence the Omega-3 Index differently depending on their composition. This study assesses omega-3 commonly found as a supplement vs a fish oil based on north atlantic fish species.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Men or women, ≥18 -65 years of age.\n2. Willing to refrain from taking omega-3 supplements for 1 month prior to study start\n3. Willing to take study supplement for 2 months\n\nExclusion Criteria:\n\n1. Subjects with known allergy to fish products\n2. Subjects known to be pregnant or breast feeding'}, 'identificationModule': {'nctId': 'NCT04768595', 'acronym': 'CetoIndex', 'briefTitle': 'Study of the Effect of Different Fish Oils on Omega-3 Index (CetoIndex)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Epax Norway AS'}, 'officialTitle': 'A Nutritional, Placebo Controlled, Randomised, Blinded Study of the Effect of Different Fish Oils on Omega-3 Index (CetoIndex)', 'orgStudyIdInfo': {'id': 'P2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '1g corn oil capsules', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Ceto 10', 'description': '1g capsules containing oil from north atlantic fish containing broad spectrum marine oil.', 'interventionNames': ['Dietary Supplement: Ceto 10']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Omega-3', 'description': '1 g capsules containing traditional, commericially available omega-3 marine oil.', 'interventionNames': ['Dietary Supplement: Fish oil']}], 'interventions': [{'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Two, 1g capsules taken daily with food', 'armGroupLabels': ['Placebo']}, {'name': 'Ceto 10', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Two, 1g capsules daily with food', 'armGroupLabels': ['Ceto 10']}, {'name': 'Fish oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Two, 1g capsules daily with food', 'armGroupLabels': ['Omega-3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6006', 'city': 'Ålesund', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Lisa Midtbø', 'role': 'CONTACT'}], 'facility': 'Møreforsking AS', 'geoPoint': {'lat': 62.47225, 'lon': 6.15492}}], 'centralContacts': [{'name': 'Derek Tobin, PhD', 'role': 'CONTACT', 'email': 'derek.tobin@pelagia.com'}], 'overallOfficials': [{'name': 'Lisa Midtbø, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Møreforsking AS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Epax Norway AS', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Møreforsking AS', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}