Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2026-01-22 @ 12:37 PM
Study NCT ID:
NCT01666392
Status:
WITHDRAWN
Last Update Posted:
2012-10-10
First Post:
2012-08-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Omega-3 Fatty Acid Supplementation in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}], '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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2013-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-10-08', 'studyFirstSubmitDate': '2012-08-10', 'studyFirstSubmitQcDate': '2012-08-15', 'lastUpdatePostDateStruct': {'date': '2012-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'EPA and DHA', 'timeFrame': 'At baseline and at 3 month endpoint', 'description': 'To determine the effectiveness of fish oil supplementation, we measure EPA and DHA Omega-3 fatty acid levels'}], 'primaryOutcomes': [{'measure': 'C-Reactive protein', 'timeFrame': 'At baseline testing and at 3 month endpoint', 'description': 'Inflammatory marker'}, {'measure': 'IL6', 'timeFrame': 'At baseline and at 3 month endpoint', 'description': 'Inflammatory cytokine'}, {'measure': 'TNFα', 'timeFrame': 'At baseline and at 3 month endpoint', 'description': 'Inflammatory cytokine'}], 'secondaryOutcomes': [{'measure': 'Skeletal muscle mass/body composition', 'timeFrame': 'At baseline testing and at 3 month endpoint', 'description': 'The amount of skeletal muscle mass and fat mass and their ration will be determined.'}, {'measure': 'Lower body muscular strength', 'timeFrame': 'At baseline and at 3 month endpoint', 'description': 'Measurement of maximum strength in the leg press exercise'}, {'measure': 'Upper body muscular strength', 'timeFrame': 'At baseline and at 3 month endpoint', 'description': 'Measurement of maximum strength in the chest press exercise'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Omega-3 fatty acid', 'Fish oil', 'Muscle mass', 'Muscle strength', 'Older adults', 'Circulating inflammatory cytokines', 'Skeletal muscle mass', 'Upper body strength', 'Lower body strength'], 'conditions': ['Inflammation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study to determine whether Fish oil (Omega-3 Fatty Acid) supplementation has an impact on inflammation and lean body mass in older adults. The investigators expect that Fish oil supplementation will reduce inflammation and prevent the loss of lean mass compared to placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 60 years of age or over\n\nExclusion Criteria:\n\n* Fish, seafood allergies, nut allergies, soy allergies\n* Habitual (\\>1/week) fish or seafood consumption\n* Current Omega-3 supplement use\n* Gastrointestinal problems\n* Current anti-inflammatory medication use\n* Current anticoagulant medication use'}, 'identificationModule': {'nctId': 'NCT01666392', 'briefTitle': 'Omega-3 Fatty Acid Supplementation in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Memphis'}, 'officialTitle': 'The Impact of Omega-3 Fatty Acid Supplementation on Markers of Inflammation and Lean Body Mass in Older Adults', 'orgStudyIdInfo': {'id': '#2232'}, 'secondaryIdInfos': [{'id': '#2232', 'type': 'OTHER', 'domain': 'The University of memphis'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fish oil (Omega-3 fatty acid)', 'description': '2 capsules/day of ProOmega providing 650mg EPA and 450mg DHA', 'interventionNames': ['Dietary Supplement: Omega-3 fatty acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Soybean oil', 'description': '2 capsules/day', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Omega-3 fatty acid', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['ProOmega (Nordic Naturals)'], 'description': 'Omega-3 fatty acid, Eicosapentaenoic acid+docosahexaenoic acid in capsule form', 'armGroupLabels': ['Fish oil (Omega-3 fatty acid)']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Placebo', 'armGroupLabels': ['Soybean oil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38152', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Department of Health and Sport Sciences, The University of Memphis', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Zsolt Murlasits, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Memphis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Memphis', 'class': 'OTHER'}, 'collaborators': [{'name': 'Nordic Naturals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Zsolt Murlasits', 'investigatorAffiliation': 'University of Memphis'}}}}