Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT00804427
Status:
COMPLETED
Last Update Posted:
2023-02-22
First Post:
2008-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Fish Oil on Plasma Triglycerides in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015228', 'term': 'Hypertriglyceridemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'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': 'D005395', 'term': 'Fish Oils'}, {'id': 'D014280', 'term': 'Triglycerides'}, {'id': 'D013024', 'term': 'Soybean Oil'}], 'ancestors': [{'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005989', 'term': 'Glycerides'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D005224', 'term': 'Fats, Unsaturated'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-18', 'studyFirstSubmitDate': '2008-12-04', 'studyFirstSubmitQcDate': '2008-12-04', 'lastUpdatePostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Triglycerides at 3 months', 'timeFrame': 'Baseline and 3 months', 'description': 'Change was calculated as the value at 3 months minus the value at baseline'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in LDL particle concentration (LDL1, LDL2, LDL3, LDL4) at 3 months', 'timeFrame': 'Baseline and 3 months', 'description': 'Change was calculated as the value at 3 months minus the value at baseline'}, {'measure': 'Change from baseline in LDL phenotype pattern (A, B, or A/B) at 3 months', 'timeFrame': 'Baseline and 3 months', 'description': 'Change was calculated as the number (and percent) of participants who improved their LDL phenotype pattern at 3 months.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fish oil', 'Triglycerides', 'Low-density Lipoprotein (LDL) cholesterol', 'Low-density Lipoprotein (LDL) subclass', 'Low-density Lipoprotein (LDL) particle size', 'Low-density Lipoprotein (LDL) phenotype'], 'conditions': ['Hypertriglyceridemia']}, 'referencesModule': {'references': [{'pmid': '21924882', 'type': 'RESULT', 'citation': 'Oelrich B, Dewell A, Gardner CD. Effect of fish oil supplementation on serum triglycerides, LDL cholesterol and LDL subfractions in hypertriglyceridemic adults. Nutr Metab Cardiovasc Dis. 2013 Apr;23(4):350-7. doi: 10.1016/j.numecd.2011.06.003. Epub 2011 Sep 15.'}], 'seeAlsoLinks': [{'url': 'https://med.stanford.edu/nutrition/research/completed-studies/fish-oil-and-triglycerides.html', 'label': 'Description of study and summary of results'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this small, short pilot study is to determine the feasibility (e.g., recruitment, dose acceptance, retention) of a future longer trial comparing the effects of two types of omega-3 fats from fish oil on plasma triglycerides. The two types of fish oil are composed of (1) omega-3 fatty acids in triglyceride form; and (2) as esterified free fatty acids (i.e. ethyl esters). Although these two types of fish oil supplements are available to the public, it remains unclear whether they are equally effective in lowering plasma triglycerides.', 'detailedDescription': 'This study is a double-blinded, parallel design, placebo controlled trial with three active treatment arms to compare the triglyceride (TG) lowering effects of the same dose of EPA and DHA provided in three formulations of supplements that differ in the proportion of omega-3 FA present as ethyl esters vs. triglycerides. The active therapy for each of the three fish oil supplementation arms is 4 g/day of combined EPA and DHA provided as: a) 90% TG formulation, b) 60% TG formulation, or c) ethyl esters (esterified fatty acids)(i.e., 0% TG). The placebo was a soy oil supplement with an identical total fat content. The primary outcome is the 12-week change in TG concentrations in the active groups vs. placebo. Secondary outcomes include LDL particle distribution, defined as either subclasses LDL1, LDL2, LDL3 and LDL4, and LDL subclass phenotype patterns A, B, or A/B.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\\*Gender: Both women and men\n\n* Age: \\> or = 18 years\n* Ethnicity and race: All ethnic and racial backgrounds welcome\n* Fasting blood triglycerides greater than or equal to 150 mg/dL\n* Planning to be available for clinic visits for the 12 weeks of study participation\n* Ability and willingness to give written informed consent\n* No known active psychiatric illness. Exclusion Criteria:\\*At screening:\n* Daily intake of dietary supplements containing omega-3 FAs within the past month.\n* Fasting blood glucose greater than or equal to 126 mg/dL\n* Self reported personal history of:\n* Clinically significant atherosclerosis (e.g., CAD, PAD)\n* Malignant neoplasm\n* Subjects currently receiving the following medications (self report):\n* Lipid lowering drugs including statins\n* Anti-hypertensive drugs: beta-blockers and thiazides\n* Body Mass Index (BMI) greater than or equal to 40.\n* Pregnant or Lactating\n* Inability to communicate effectively with study personnel'}, 'identificationModule': {'nctId': 'NCT00804427', 'briefTitle': 'Effect of Fish Oil on Plasma Triglycerides in Adults', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Effect of Fish Oil as an Ethyl Ester or Triglyceride Preparation on Plasma Triglycerides in Hypertriglyceridemic Adults', 'orgStudyIdInfo': {'id': 'SU-12042008-1358'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fish oil (90% triglycerides)', 'description': 'Fish oil (4 grams/day of combined EPA and DHA) as 90% triglyceride formulation, taken in two divided doses with main meals.', 'interventionNames': ['Dietary Supplement: Fish oil (90% triglycerides)']}, {'type': 'EXPERIMENTAL', 'label': 'Fish oil (60% triglycerides)', 'description': 'Fish oil (4 grams/day of combined EPA and DHA) as 60% triglyceride formulation, taken in two divided doses with main meals.', 'interventionNames': ['Dietary Supplement: Fish oil (60% triglycerides)']}, {'type': 'EXPERIMENTAL', 'label': 'Fish oil (ethyl esters)', 'description': 'Fish oil (4 grams/day of combined EPA and DHA) as ethyl esters formulation (0% triglycerides), taken in two divided doses with main meals.', 'interventionNames': ['Dietary Supplement: Fish oil (ethyl esters)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Soy oil', 'description': 'Soy oil supplement with identical total fat content, taken in two divided doses with main meals.', 'interventionNames': ['Dietary Supplement: Soy oil']}], 'interventions': [{'name': 'Fish oil (90% triglycerides)', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Fish oil (90% triglycerides)']}, {'name': 'Fish oil (60% triglycerides)', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Fish oil (60% triglycerides)']}, {'name': 'Fish oil (ethyl esters)', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Fish oil (ethyl esters)']}, {'name': 'Soy oil', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Soy oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Christopher D Gardner', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nordic Naturals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine (Research)', 'investigatorFullName': 'Christopher Gardner', 'investigatorAffiliation': 'Stanford University'}}}}