Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2026-03-03 @ 10:06 AM
Study NCT ID:
NCT01960660
Status:
COMPLETED
Last Update Posted:
2015-12-14
First Post:
2013-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Marketing-oriented Study to Evaluate the Comparative Bioavailability of Omega-3 Fatty Acids From Four Different Natural Health Products
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D004281', 'term': 'Docosahexaenoic Acids'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-10', 'studyFirstSubmitDate': '2013-10-08', 'studyFirstSubmitQcDate': '2013-10-09', 'lastUpdatePostDateStruct': {'date': '2015-12-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Omega-Score', 'timeFrame': 'Change from Baseline in Omega-Score at 28 days', 'description': 'The Omega ScoreTM is a measurement of the levels of the Omega-3 Fatty Acids in a blood sample. The summed amounts of these Omega-3 Fatty Acids (EPA+DPA+DHA) as a % of the total fatty acids represents the Omega ScoreTM in whole blood.'}], 'secondaryOutcomes': [{'measure': 'Lipemic IndexTM', 'timeFrame': 'Change from Baseline in Lipemic Index at 28 days', 'description': 'The Lipemic Index™ is the post-prandial rise in TG levels over a 5-hour period, following the consumption drink containing a measured amount of fat, carbohydrate and protein.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fish Oil', 'EPA', 'DHA', 'Omega-Score', 'Lipemic Index', 'ethyl esters', 'triglycerides', 'phospholipids'], 'conditions': ['Comparative Bioavailability']}, 'referencesModule': {'references': [{'pmid': '24952576', 'type': 'DERIVED', 'citation': "Laidlaw M, Cockerline CA, Rowe WJ. A randomized clinical trial to determine the efficacy of manufacturers' recommended doses of omega-3 fatty acids from different sources in facilitating cardiovascular disease risk reduction. Lipids Health Dis. 2014 Jun 21;13:99. doi: 10.1186/1476-511X-13-99."}]}, 'descriptionModule': {'briefSummary': "Supplementation with omega-3 fatty acids has been extensively researched and is known to provide healthful benefits for patients with a diversity of conditions and diseases. Not all omega-3 supplements are created equally however; some sources of omega-3 fatty acids are superior to others due to a greater bioavailability of omega-3 fatty acids than others, differences in source material, and processing techniques.\n\nThe purpose of this study is to determine which marketed omega-3 product provided the greatest effect, as measured against its' label claim and recommended dosage."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is fluent in English\n* Participant understands the study requirements and is willing to comply with the protocol\n* Participant is willing to provide written informed consent\n* Participant is 18 years of age or older\n\nExclusion Criteria:\n\n* Unwilling or unable to provide written consent\n* Participant has taken omega-3 supplements in the last 3 months\n* Participants consumes fish on a regular basis (more than 1 serving per week)\n* Females who are pregnant or breastfeeding\n* Participant has an allergy to fish or seafood\n* Participant has been diagnosed with any medical illness or conditions\n* Participant has a history of drug dependence or substance abuse (excluding nicotine)\n* Participant is taking cholesterol or triglyceride lowering medications or supplements (statins, niacin, carnitine, fibrates)\n* Individual has difficulty giving multiple blood samples'}, 'identificationModule': {'nctId': 'NCT01960660', 'briefTitle': 'A Marketing-oriented Study to Evaluate the Comparative Bioavailability of Omega-3 Fatty Acids From Four Different Natural Health Products', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nordic Pharma, USA'}, 'officialTitle': 'A Marketing-oriented Study to Evaluate the Comparative Bioavailability of Omega-3 Fatty Acids From Four Different Natural Health Products', 'orgStudyIdInfo': {'id': '12.0216'}, 'secondaryIdInfos': [{'id': '12-03-001', 'type': 'OTHER', 'domain': 'Canadian SHIELD Ethics Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Investigational Product', 'description': 'Omega-3 fatty acids in the form of triglycerides', 'interventionNames': ['Dietary Supplement: Omega-3 Fatty Acids']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator Product 1', 'description': 'Omega-3 fatty acids in the form of ethyl esters.', 'interventionNames': ['Dietary Supplement: Omega-3 Fatty Acids']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator Product 2', 'description': 'Omega-3 fatty acids in the form of phospholipids from krill oil.', 'interventionNames': ['Dietary Supplement: Omega-3 Fatty Acids']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Comparator Product 3', 'description': 'Omega-3 fatty acids from salmon oil.', 'interventionNames': ['Dietary Supplement: Omega-3 Fatty Acids']}], 'interventions': [{'name': 'Omega-3 Fatty Acids', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['EPA: Eicosapentaenoic acid (20:5(n-3))', 'DHA: Docosahexaenoic acid (22:6(n-3))'], 'armGroupLabels': ['Comparator Product 1', 'Comparator Product 2', 'Comparator Product 3', 'Investigational Product']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N1G0B4', 'city': 'Guelph', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Nutrasource Diagnostics Inc', 'geoPoint': {'lat': 43.54594, 'lon': -80.25599}}], 'overallOfficials': [{'name': 'Maggie D Laidlaw, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nutrasource Diagnostics'}, {'name': 'Carla Cockerline, M.Sc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nutrasource Diagnostics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nordic Pharma, USA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Nutrasource Pharmaceutical and Nutraceutical Services, Inc.', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'SPONSOR'}}}}