Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:26 AM
Study NCT ID:
NCT01183520
Status:
COMPLETED
Last Update Posted:
2022-02-02
First Post:
2010-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of High Omega-3 Fish Intake on Lipid Peroxidation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-18', 'studyFirstSubmitDate': '2010-08-16', 'studyFirstSubmitQcDate': '2010-08-16', 'lastUpdatePostDateStruct': {'date': '2022-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Long chain omega-3 fatty acid (n-3)', 'timeFrame': '6 months', 'description': 'Effect of different levels of n-3 intake on n-3 fatty acids in plasma lipoproteins, cell and tissue lipids (cell enrichment)'}], 'secondaryOutcomes': [{'measure': 'lipid peroxidation', 'timeFrame': '6 months', 'description': 'Effect of different levels of n-3 intake on lipid peroxidation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Omega-3 Fatty Acids', 'Lipid Peroxidation']}, 'referencesModule': {'references': [{'pmid': '2873160', 'type': 'BACKGROUND', 'citation': 'Holman RT. Control of polyunsaturated acids in tissue lipids. J Am Coll Nutr. 1986;5(2):183-211. doi: 10.1080/07315724.1986.10720125.'}, {'pmid': '11160538', 'type': 'BACKGROUND', 'citation': 'Raatz SK, Bibus D, Thomas W, Kris-Etherton P. Total fat intake modifies plasma fatty acid composition in humans. J Nutr. 2001 Feb;131(2):231-4. doi: 10.1093/jn/131.2.231.'}, {'pmid': '9593698', 'type': 'BACKGROUND', 'citation': 'Roberts LJ 2nd, Montine TJ, Markesbery WR, Tapper AR, Hardy P, Chemtob S, Dettbarn WD, Morrow JD. Formation of isoprostane-like compounds (neuroprostanes) in vivo from docosahexaenoic acid. J Biol Chem. 1998 May 29;273(22):13605-12. doi: 10.1074/jbc.273.22.13605.'}, {'pmid': '19520854', 'type': 'BACKGROUND', 'citation': 'Song WL, Paschos G, Fries S, Reilly MP, Yu Y, Rokach J, Chang CT, Patel P, Lawson JA, Fitzgerald GA. Novel eicosapentaenoic acid-derived F3-isoprostanes as biomarkers of lipid peroxidation. J Biol Chem. 2009 Aug 28;284(35):23636-43. doi: 10.1074/jbc.M109.024075. Epub 2009 Jun 11.'}, {'pmid': '15037162', 'type': 'BACKGROUND', 'citation': 'Roberts LJ 2nd, Fessel JP. The biochemistry of the isoprostane, neuroprostane, and isofuran pathways of lipid peroxidation. Chem Phys Lipids. 2004 Mar;128(1-2):173-86. doi: 10.1016/j.chemphyslip.2003.09.016.'}, {'pmid': '25604640', 'type': 'DERIVED', 'citation': 'Raatz SK, Scheett AJ, Johnson LK, Jahns L. Validity of electronic diet recording nutrient estimates compared to dietitian analysis of diet records: randomized controlled trial. J Med Internet Res. 2015 Jan 20;17(1):e21. doi: 10.2196/jmir.3744.'}], 'seeAlsoLinks': [{'url': 'https://www.ars.usda.gov/plains-area/gfnd/gfhnrc/', 'label': 'USDA Grand Forks Human Nutrition Research Center'}]}, 'descriptionModule': {'briefSummary': 'The overall goal of this project is to identify an appropriate level of high omega-3 fish (salmon) consumption that will promote optimal omega 3 nutritional status without increasing the level of lipid oxidation in the body.', 'detailedDescription': 'Studies have demonstrated that the intakes of fatty fish and fish oils are associated with decreases in cardiovascular disease and other chronic disease states. This is related to the long chain omega-3 fatty acid (n-3) content of fish and fish oil, specifically eicosapentaenoic acid and docosahexaenoic acid. Although the consumption of high n-3 fish is recommended in the 2005 US Dietary Guidelines for Americans, no specific consumption levels are made for the fatty acid eicosapentaenoic acid (EPA) and/or the fatty acid docosahexaenoic acid (DHA) or total fish intake.\n\nConsumption of high n-3 fish or dietary supplementation of fish oil will lead to increased levels of these fatty acids in plasma lipoproteins, cell and tissue lipid. This change in membrane lipid is thought to be responsible for the anti-inflammatory effects of n-3. Because highly unsaturated fatty acid are subject to peroxidation, the level of fish intake that is sufficient to modify membrane n-3 content and the exact level that enhances peroxidation is unknown.\n\nWe will perform a dose-response feeling study in which varied levels of fish (salmon) will be provided in random order separated by 4 or more week washout periods. We will assess the level of cell membrane enrichment with n-3 and the effect on lipid peroxidation outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 25-34.9\n* Non-smoker\n* Free of major medical conditions\n* Willing to comply with protocol requirements\n\nExclusion Criteria:\n\n* Use of lipid modifying drugs or supplements\n* Taking fish oil or flax supplements\n* Regular fish consumer\n* Planning to gain to lose weight\n* Pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT01183520', 'briefTitle': 'Effect of High Omega-3 Fish Intake on Lipid Peroxidation', 'organization': {'class': 'FED', 'fullName': 'USDA Grand Forks Human Nutrition Research Center'}, 'officialTitle': 'Effect of High Omega-3 Fish Intake on Lipid Peroxidation', 'orgStudyIdInfo': {'id': 'GFHNRC017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '90 grams of Salmon', 'description': 'Subjects will consume 90 grams of salmon twice a week for 4 weeks', 'interventionNames': ['Dietary Supplement: Omega-3 fish oil provided by salmon']}, {'type': 'ACTIVE_COMPARATOR', 'label': '180 grams of salmon', 'description': 'Subjects will consume 180 grams of salmon twice a week for 4 weeks', 'interventionNames': ['Dietary Supplement: Omega-3 fish oil provided by salmon']}, {'type': 'ACTIVE_COMPARATOR', 'label': '270 Grams of Salmon', 'description': 'Subjects will consume 270 grams of salmon twice a week for 4 weeks', 'interventionNames': ['Dietary Supplement: Omega-3 fish oil provided by salmon']}], 'interventions': [{'name': 'Omega-3 fish oil provided by salmon', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Eating 3 different amounts of provided salmon twice a week for four weeks', 'armGroupLabels': ['180 grams of salmon', '270 Grams of Salmon', '90 grams of Salmon']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58202', 'city': 'Grand Forks', 'state': 'North Dakota', 'country': 'United States', 'facility': 'USDA ARS Grand Forks Human Nutrition Research Center', 'geoPoint': {'lat': 47.92526, 'lon': -97.03285}}], 'overallOfficials': [{'name': 'Matthew Picklo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'USDA Grand Forks Human Nutrition Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'USDA Grand Forks Human Nutrition Research Center', 'class': 'FED'}, 'collaborators': [{'name': 'United States Department of Agriculture (USDA)', 'class': 'FED'}, {'name': 'University of North Dakota', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}