Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-02-24 @ 3:13 PM
Study NCT ID:
NCT00350194
Status:
UNKNOWN
Last Update Posted:
2012-03-02
First Post:
2006-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Omega-3 Fatty Acids on Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D005395', 'term': 'Fish Oils'}], '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': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-02-29', 'studyFirstSubmitDate': '2006-07-06', 'studyFirstSubmitQcDate': '2006-07-06', 'lastUpdatePostDateStruct': {'date': '2012-03-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Carotid IMT', 'timeFrame': '1 year, 2 years'}], 'secondaryOutcomes': [{'measure': 'Lipid (apolipoproteins and lipid parameters)', 'timeFrame': '1 year, 2 years'}, {'measure': 'hs-CRP & SAA', 'timeFrame': '1 year, 2 years'}, {'measure': 'Glucose', 'timeFrame': '1 year, 2 years'}, {'measure': 'Insulin', 'timeFrame': '1 year, 2 years'}, {'measure': 'adiponectin', 'timeFrame': '1 year, 2 years'}, {'measure': 'urine microalbumin/creatinine', 'timeFrame': '1 year, 2 years'}, {'measure': 'Serum Fatty Acids', 'timeFrame': '1 year, 2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Fatty Acids, Omega-3'], 'conditions': ['Metabolic Syndrome X']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effects of omega-3 fatty acids in the form of fish oil supplementation (approximately 2 grams per day) on the carotid intima-media (CIMT)progression (primary objective) and 2)(Secondary objective) lipid markers such as LDL, apo-B, and LDL buoyancy, on inflammatory burden as measured by CRP, on oxidative stress as measured by urinary isoprostanes, urine microalbumin/creatinine, and serum adiponectin a fat derived hormone in subjects with metabolic syndrome.', 'detailedDescription': 'This translational pilot study will have a double-blind, placebo-controlled, parallel design. We will enroll one hundred subjects who meet at least 3 of the 5 criteria for metabolic syndrome as per NCEP guidelines/WHO guidelines and who do not have known cardiovascular disease or diabetes. They will receive either placebo or omega-3 fatty acids in the form of fish oil capsules for a two-year period. Assessment of, C-IMT, serum lipoprotein profile, LDL- buoyancy, adiponectin, CRP, SAA, apolipoprotein B and A-1, fasting glucose, fasting insulin levels, and plasma fatty acids will be measured at baseline, one year, and two years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with Metabolic Syndrome (meets 3 of the following 5)\n* Abdominal obesity, waist circumference in men greater than 40 in. \\& in women greater than 35 in.\n* Serum triglycerides greater than or = 150 mg/dL (1.7 mmol/L)\n* Serum HDL cholesterol less than or = 40 mg/dL in men and less than 50 mg/dL in women\n* Blood pressure greater than or = 130/85 mmHg or drug treatment for elevated blood pressure\n* Fasting plasma glucose greater than 100 mg/dL\n\nExclusion Criteria:\n\n* Diabetes\n* Known or documented CHD (including ECG consistent with prior MI), CVA (including TIA), PVD (including symptoms of claudication)\n* Angina or other chest pain that may indicate CHD\n* Clinically significant neoplastic, cardiovascular, hepatic, renal, metabolic, endocrine (untreated or unstable), or psychiatric (untreated or unstable)\n* Known abnormal LFTS greater than 2X ULN\n* Smoker, illicit drug use, or excessive alcohol use\n* Medications: Lipid lowering therapy, daily NSAID or greater than 325 mg ASA (PRN use ok), clopidogrel (or equivalent), Coumadin, Omega-3 fatty acid supplement, other investigational drugs within 30 days of study entry, high omega-3 fatty acid content in diet within past three months\n* Pregnancy or planning pregnancy during the study period\n* Sensitivity or allergy to fish'}, 'identificationModule': {'nctId': 'NCT00350194', 'briefTitle': 'The Effects of Omega-3 Fatty Acids on Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'Pilot Study: The Effects of Omega-3 Fatty Acids on Metabolic Syndrome and Vascular Structure in Metabolic Syndrome as Assessed by Carotid IMT', 'orgStudyIdInfo': {'id': '28791-D'}, 'secondaryIdInfos': [{'id': '05-8693-D 03'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Omega-3 fatty acid vs. placebo comparator', 'interventionNames': ['Dietary Supplement: Omega-3 fatty acids']}], 'interventions': [{'name': 'Omega-3 fatty acids', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Fish Oil'], 'description': 'Total of 1.8 grams of EPA +DHA in the form of fish oil capsules (3/day)', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Lipid Research Clinic (University of Washington Affiliated)', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Pathmaja Paramsothy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'Northwest Lipid Research Clinic', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Pathmaja Paramsothy', 'investigatorAffiliation': 'University of Washington'}}}}