Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-02-26 @ 12:37 AM
Study NCT ID:
NCT03378232
Status:
COMPLETED
Last Update Posted:
2018-02-20
First Post:
2017-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiometabolic Benefits of Omega-3 Polyunsaturated Fatty Acids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Participant as well as student investigators were blinded to the treatment randomization.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-16', 'studyFirstSubmitDate': '2017-12-12', 'studyFirstSubmitQcDate': '2017-12-17', 'lastUpdatePostDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Omega-3 Index', 'timeFrame': 'CHANGE from Baseline at 12 weeks', 'description': 'Omega-3 Index, as determined by measuring omega-3 fats in red blood cells using gas chromatography'}], 'secondaryOutcomes': [{'measure': 'Triglycerides', 'timeFrame': 'CHANGE from Baseline at 12 weeks', 'description': 'Fasted serum triglycerides (mmol/L)'}, {'measure': 'High-sensitivity C-Reactive Protein (hs-CRP)', 'timeFrame': 'CHANGE from Baseline at 12 weeks', 'description': 'Blood hs-CRP levels'}, {'measure': 'Energy Expenditure', 'timeFrame': 'CHANGE from Baseline at 12 weeks', 'description': 'Resting Metabolic Rate'}, {'measure': 'Blood Pressure', 'timeFrame': 'CHANGE from Baseline at 12 weeks', 'description': 'Both systolic and diastolic blood pressure will be assessed'}, {'measure': 'Muscle sympathetic nerve activity (MSNA)', 'timeFrame': 'Change from Baseline at 12 weeks', 'description': 'Fibular nerve microneurography'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['DHA', 'EPA', 'fatty acids', 'blood pressure', 'resting metabolic rate', 'blood lipids', 'muscle sympathetic nerve activity (MSNA)'], 'conditions': ['Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '24936800', 'type': 'BACKGROUND', 'citation': 'Roke K, Mutch DM. The role of FADS1/2 polymorphisms on cardiometabolic markers and fatty acid profiles in young adults consuming fish oil supplements. Nutrients. 2014 Jun 16;6(6):2290-304. doi: 10.3390/nu6062290.'}, {'pmid': '27144909', 'type': 'BACKGROUND', 'citation': 'Roke K, Jannas-Vela S, Spriet LL, Mutch DM. FADS2 genotype influences whole-body resting fat oxidation in young adult men. Appl Physiol Nutr Metab. 2016 Jul;41(7):791-4. doi: 10.1139/apnm-2016-0043. Epub 2016 Mar 16.'}, {'pmid': '24610882', 'type': 'BACKGROUND', 'citation': 'Miller PE, Van Elswyk M, Alexander DD. Long-chain omega-3 fatty acids eicosapentaenoic acid and docosahexaenoic acid and blood pressure: a meta-analysis of randomized controlled trials. Am J Hypertens. 2014 Jul;27(7):885-96. doi: 10.1093/ajh/hpu024. Epub 2014 Mar 6.'}, {'pmid': '20565855', 'type': 'BACKGROUND', 'citation': 'Merino DM, Ma DW, Mutch DM. Genetic variation in lipid desaturases and its impact on the development of human disease. Lipids Health Dis. 2010 Jun 18;9:63. doi: 10.1186/1476-511X-9-63.'}, {'pmid': '29080057', 'type': 'BACKGROUND', 'citation': 'Klingel SL, Roke K, Hidalgo B, Aslibekyan S, Straka RJ, An P, Province MA, Hopkins PN, Arnett DK, Ordovas JM, Lai CQ, Mutch DM. Sex Differences in Blood HDL-c, the Total Cholesterol/HDL-c Ratio, and Palmitoleic Acid are Not Associated with Variants in Common Candidate Genes. Lipids. 2017 Dec;52(12):969-980. doi: 10.1007/s11745-017-4307-5. Epub 2017 Oct 27.'}, {'pmid': '38649096', 'type': 'DERIVED', 'citation': 'Metherel AH, Valenzuela R, Klievik BJ, Cisbani G, Rotarescu RD, Gonzalez-Soto M, Cruciani-Guglielmacci C, Laye S, Magnan C, Mutch DM, Bazinet RP. Dietary docosahexaenoic acid (DHA) downregulates liver DHA synthesis by inhibiting eicosapentaenoic acid elongation. J Lipid Res. 2024 Jun;65(6):100548. doi: 10.1016/j.jlr.2024.100548. Epub 2024 Apr 20.'}, {'pmid': '31535138', 'type': 'DERIVED', 'citation': 'Klingel SL, Metherel AH, Irfan M, Rajna A, Chabowski A, Bazinet RP, Mutch DM. EPA and DHA have divergent effects on serum triglycerides and lipogenesis, but similar effects on lipoprotein lipase activity: a randomized controlled trial. Am J Clin Nutr. 2019 Dec 1;110(6):1502-1509. doi: 10.1093/ajcn/nqz234.'}, {'pmid': '31204771', 'type': 'DERIVED', 'citation': 'Metherel AH, Irfan M, Klingel SL, Mutch DM, Bazinet RP. Compound-specific isotope analysis reveals no retroconversion of DHA to EPA but substantial conversion of EPA to DHA following supplementation: a randomized control trial. Am J Clin Nutr. 2019 Oct 1;110(4):823-831. doi: 10.1093/ajcn/nqz097.'}]}, 'descriptionModule': {'briefSummary': 'Omega 3 fatty acids have been shown to provide a number of cardiometabolic benefits in both healthy and at risk populations. Specifically, the daily consumption of fish oil supplements has been reported to reduce blood triglyceride levels, and influence glucose homeostasis and whole-body inflammation. Furthermore, a number of cardiovascular effects (i.e. reduced blood pressure, reduced coagulation) have been found to result from omega-3 consumption, as well as influencing energy expenditure (i.e. resting metabolic rate). The goal of this study is to examine the cardiometabolic and cardiovascular effects that result from long-term consumption of omega-3 fatty acids.', 'detailedDescription': "Cardiovascular disease (CVD) and type 2 diabetes (T2D) are major contributors to healthcare costs in Canada. A cluster of cardiometabolic risk factors including insulin resistance, dyslipidemia, hypertension, and abdominal obesity increases the risk of developing the aforementioned diseases. While drugs can help to treat or slow the development of cardiometabolic problems, they are not always effective and in some instances can have adverse effects on a patient's health. In comparison, changing, modifying or improving dietary habits is now recognized as a safe and effective way to help reduce the risk of developing CVD, as well as treat CVD and T2D. The consumption of omega-3 fatty acids (FAs) is highly recommended due to their known benefits for health and development; however, considerable variability exists in the literature regarding the benefits of omega-3 FAs. This variability stems from differences in study design; differing in dosage, duration of supplementation, population studied, sample size, as well as the amounts of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) used in supplements. The current study will investigate the effects of EPA and DHA on markers of cardiometabolic and cardiovascular health in young adults.\n\nTo assess the effectiveness of EPA and DHA on markers of cardiometabolic health, including\n\n1. blood lipids, such as triglycerides, total cholesterol, high-density lipoprotein (HDL) and low-density lipoprotein (LDL) levels\n2. markers of inflammation, such as high-sensitivity C-reactive protein (hs-CRP) and other circulating cytokines\n3. whole-body glucose and insulin levels\n4. resting metabolic rate\n5. blood pressure and muscle sympathetic nerve activity"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of 18-30 years\n* Healthy\n\nExclusion Criteria:\n\n* Younger than 18 years\n* Older than 30 years\n* Allergic to fish and/or shellfish or gelatin\n* High consumption of omega-3 fats (either fatty fish or dietary supplements)\n* Chronic or communicable diseases\n* Anticipated change in lifestyle (moving to a new house, starting a new fitness routine).\n* Discomfort giving blood\n* Use of lipid-controlling medication, including cholesterol lowering drugs (statins), fatty acid/triglyceride altering (fibrates) or any other drug known to have lipid altering effects, such as ezetimibe, colesevelam, torcetrapib, avasimibe, and implitapide\n* Chronic use of anti-inflammatory medications\n* Pregnant, or is planning to become pregnant during the study'}, 'identificationModule': {'nctId': 'NCT03378232', 'acronym': 'TGIF', 'briefTitle': 'Cardiometabolic Benefits of Omega-3 Polyunsaturated Fatty Acids', 'organization': {'class': 'OTHER', 'fullName': 'University of Guelph'}, 'officialTitle': 'EPA and DHA Regulation of Blood Triglycerides, Resting Metabolic Rate and Blood Markers of Cardiometabolic Health.', 'orgStudyIdInfo': {'id': 'The Goodness In Fish Oil'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Olive Oil', 'description': 'Placebo supplement with olive oil', 'interventionNames': ['Dietary Supplement: Placebo Olive Oil']}, {'type': 'EXPERIMENTAL', 'label': 'High EPA Supplement', 'description': 'Supplements providing up to 3g per day of Omega-3, with increased EPA', 'interventionNames': ['Dietary Supplement: High EPA Supplement']}, {'type': 'EXPERIMENTAL', 'label': 'High DHA Supplement', 'description': 'Supplements providing up to 3g per day of Omega-3, with increased DHA', 'interventionNames': ['Dietary Supplement: High DHA Supplement']}], 'interventions': [{'name': 'Placebo Olive Oil', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Each participant was instructed to consume the dietary supplement on a daily basis for 12 weeks.', 'armGroupLabels': ['Placebo Olive Oil']}, {'name': 'High EPA Supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Each participant was instructed to consume assigned dietary supplement on a daily basis for 12 weeks.', 'armGroupLabels': ['High EPA Supplement']}, {'name': 'High DHA Supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Each participant was instructed to consume assigned dietary supplement on a daily basis for 12 weeks.', 'armGroupLabels': ['High DHA Supplement']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'David M Mutch, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Guelph'}, {'name': 'Phillip Millar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Guelph'}, {'name': 'Lawrence Spriet, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Guelph'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Guelph', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ontario Ministry of Agriculture, Food and Rural Affairs', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'David M Mutch', 'investigatorAffiliation': 'University of Guelph'}}}}