Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2025-12-24 @ 5:58 PM
Study NCT ID:
NCT06802068
Status:
RECRUITING
Last Update Posted:
2025-02-20
First Post:
2025-01-27
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Change in Omega 3 Index in Healthy Adults with OmeGo or a Standard Omega-3 Oil Supplement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003060', 'term': 'Cod Liver Oil'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized to either a whole salmon oil supplement or a cod liver oil supplement.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2025-01-27', 'studyFirstSubmitQcDate': '2025-01-27', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess and compare the bioavailability of a natural salmon oil with that of a standard omega-3 supplement', 'timeFrame': '18 weeks', 'description': 'Change in omega-3 index after 14 weeks supplementation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Omega-3 index, salmon oil CARDIO, omega-3 oil'], 'conditions': ['Supplementation in Healthy Adults to Assess Impact on Omega 3 Index and Cardiometabolic Health']}, 'referencesModule': {'references': [{'pmid': '30954305', 'type': 'BACKGROUND', 'citation': 'GBD 2017 Diet Collaborators. Health effects of dietary risks in 195 countries, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2019 May 11;393(10184):1958-1972. doi: 10.1016/S0140-6736(19)30041-8. Epub 2019 Apr 4.'}]}, 'descriptionModule': {'briefSummary': 'Omega-3 index is used as a proxy for an adequate intake of fish unsaturated fats in the diet. However, omega-3 supplements have not consistently shown the health benefits of eating fresh fish. This study will assess the change in omega-3 index and impact on markers of cardiometabolic health with two different supplements: a whole, unprocessed salmon oil and a standard, processed, concentrated oemga-3 oil. The markers to be studies included impact on inflammation and oxidative stress, cholesterol and markers of risk of diabetes. Change in sleep metrics will also be assessed.', 'detailedDescription': 'Omega-3 index is used as a proxy for an adequate intake of fish unsaturated fats in the diet. However, omega-3 supplements have not consistently shown the health benefits akin to eating fresh fish. This could be because contains many more fats than just EPA and DHA and these other fats have well defined health benefits such as oleic acid which is also abundant in olive oil. Alternatively this might be a result of significant processing needed to extract and concentrate the omega-3 fraction resulting in elevated levels of oxidation and free fatty acids, both of which are pro-inflammatory and would therefore impair the health benefits of omega-3. This study will assess the change in omega-3 index and impact on markers of cardiometabolic health with two different supplements: a whole, unprocessed salmon oil and a standard, processed, concentrated oemga-3 oil. The markers to be studies included impact on common drivers of inflammation and oxidative stress, blood cholesterol and markers of the risk of developing diabetes. Change in sleep metrics will also be assessed using both questionnaires and data from the hypnograms recorded by wearable device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, non-pregnant adults; 40-80 years of age; stable body weight prior 3 months\n\nExclusion Criteria:\n\n* Fish or seafood allergies; Pregnant; already consuming fish oil supplementation; malabsorption states; malignancy in remission for less than 12 months; diabetic'}, 'identificationModule': {'nctId': 'NCT06802068', 'briefTitle': 'Change in Omega 3 Index in Healthy Adults with OmeGo or a Standard Omega-3 Oil Supplement', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hofseth Biocare ASA'}, 'officialTitle': 'A Randomized Controlled Clinical Trial Assessing the Impact of 14-week Natural Salmon Oil Supplementation (CARDIO®) on the Omega-3 Index Response and Cardiometabolic and Inflammatory Biomarkers in Healthy, Non-Pregnant Adults', 'orgStudyIdInfo': {'id': 'HBC-CARDIO-2024-001-v2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CARDIO salmon oil soft gel capsules', 'description': 'A minimally processed, whole salmon oil containing all the fatty acid fractions found in salmon', 'interventionNames': ['Dietary Supplement: whole salmon oil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Omega-3 cod liver oil soft gel capsules', 'description': 'A standard, processed, concentrated omega-3 supplement', 'interventionNames': ['Dietary Supplement: Cod liver oil']}], 'interventions': [{'name': 'whole salmon oil', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['CARDIO oil'], 'description': 'A minimally processed whole salmon oil', 'armGroupLabels': ['CARDIO salmon oil soft gel capsules']}, {'name': 'Cod liver oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Standard, processed omega-3 cod liver oil', 'armGroupLabels': ['Omega-3 cod liver oil soft gel capsules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94025', 'city': 'Menlo Park', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Zeenia Framroze', 'role': 'CONTACT', 'phone': '1-650-206-8006'}], 'facility': 'Alethios', 'geoPoint': {'lat': 37.45383, 'lon': -122.18219}}, {'zip': '94109', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Zeenia Framroze', 'role': 'CONTACT', 'email': 'zeenia@alethios.com'}, {'name': 'Gurpreet Atwal', 'role': 'CONTACT', 'email': 'gurpreet@alethios.com'}], 'facility': 'Alethios, Inc.', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Crawford Currie, MBBS', 'role': 'CONTACT', 'email': 'cc@hofsethbiocare.no', 'phone': '1-650-206-8006'}, {'name': 'Christian Bjerknes, MD', 'role': 'CONTACT', 'email': 'chbj@hofsethbiocare.no', 'phone': '1-650-206-8006'}], 'overallOfficials': [{'name': 'Crawford Currie, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HBC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'We will put the anonymized data from the study onto the Figshare platform so that journal reviewers and editors can review it as well as other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hofseth Biocare ASA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}