Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-03-11 @ 11:06 PM
Study NCT ID:
NCT03025620
Status:
COMPLETED
Last Update Posted:
2017-01-19
First Post:
2017-01-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Intake of Alpha-linolenic Acid in Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074262', 'term': 'Rapeseed Oil'}, {'id': 'D017962', 'term': 'alpha-Linolenic Acid'}, {'id': 'D000074242', 'term': 'Sunflower Oil'}, {'id': 'D019787', 'term': 'Linoleic Acid'}], 'ancestors': [{'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008042', 'term': 'Linolenic Acids'}, {'id': 'D005228', 'term': 'Fatty Acids, Essential'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008041', 'term': 'Linoleic Acids'}, {'id': 'D043371', 'term': 'Fatty Acids, Omega-6'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 254}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-18', 'studyFirstSubmitDate': '2017-01-10', 'studyFirstSubmitQcDate': '2017-01-18', 'lastUpdatePostDateStruct': {'date': '2017-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of diet supplementation on fatty acid composition in serum and red cell membrane phospholipids, at the end of dietary period', 'timeFrame': '6 weeks', 'description': 'Blood samples have been done at the beginning and at the end of the dietary period. Fatty acids analyses of the red cells and serum have been performed by GC method.'}], 'secondaryOutcomes': [{'measure': 'Pulse wave velocity (PWV)', 'timeFrame': '6 weeks', 'description': 'Pulse wave velocity values have been performed at the beginning and the end of the dietary period.\n\nThe purpose was to evaluate the relationship between PWV and dietary intakes of ALA.'}, {'measure': 'Others', 'timeFrame': '6 weeks', 'description': 'ApoB ApoA1 Oxydative parameters (ie CRP) Lp(a)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Alphalinolenic acid', 'Lipid cardiovascular risk factors', 'Inflammation'], 'conditions': ['Cardiovascular Diseases', 'Inflammation', 'Metabolism Disorder, Lipid']}, 'referencesModule': {'references': [{'pmid': '20667934', 'type': 'BACKGROUND', 'citation': 'Giallauria F, Vigorito C, Tramarin R, Fattirolli F, Ambrosetti M, De Feo S, Griffo R, Riccio C, Piepoli M; ISYDE-2008 Investigators of the Italian Association for Cardiovascular Prevention, Rehabilitation, and Prevention. Cardiac rehabilitation in very old patients: data from the Italian Survey on Cardiac Rehabilitation-2008 (ISYDE-2008)--official report of the Italian Association for Cardiovascular Prevention, Rehabilitation, and Epidemiology. J Gerontol A Biol Sci Med Sci. 2010 Dec;65(12):1353-61. doi: 10.1093/gerona/glq138. Epub 2010 Jul 28.'}, {'pmid': '21076723', 'type': 'BACKGROUND', 'citation': 'Rodriguez-Leyva D, Dupasquier CM, McCullough R, Pierce GN. The cardiovascular effects of flaxseed and its omega-3 fatty acid, alpha-linolenic acid. Can J Cardiol. 2010 Nov;26(9):489-96. doi: 10.1016/s0828-282x(10)70455-4.'}, {'pmid': '15304539', 'type': 'BACKGROUND', 'citation': 'Salva A, Corman B, Andrieu S, Salas J, Vellas B; International Association Of Gerontology/International Academy Of Nutrition And Aging Task Force. Minimum data set for nutritional intervention studies in elderly people. J Gerontol A Biol Sci Med Sci. 2004 Jul;59(7):724-9. doi: 10.1093/gerona/59.7.m724.'}, {'pmid': '16799140', 'type': 'BACKGROUND', 'citation': 'Bischoff HA, Staehelin HB, Willett WC. The effect of undernutrition in the development of frailty in older persons. J Gerontol A Biol Sci Med Sci. 2006 Jun;61(6):585-9. doi: 10.1093/gerona/61.6.585. No abstract available.'}, {'pmid': '19196012', 'type': 'BACKGROUND', 'citation': 'Abbatecola AM, Cherubini A, Guralnik JM, Andres Lacueva C, Ruggiero C, Maggio M, Bandinelli S, Paolisso G, Ferrucci L. Plasma polyunsaturated fatty acids and age-related physical performance decline. Rejuvenation Res. 2009 Feb;12(1):25-32. doi: 10.1089/rej.2008.0799.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the antiatherogenic and anti-inflammatory potential of an adequate intake of alpha-linolenic acid in elderly.', 'detailedDescription': 'There is growing evidence that diets high in long chain n-3 polyunsaturated fatty acids (PUFA) decrease the risk of fatal ischemic heart disease.Both epidemiologic studies and clinical trials demonstrate substantial cardioprotective effects of alpha linolenic acid (ALA) from vegetable oils.However, little is known about the relation of the dietary intake of ALA with ischemic heart disease among older adults.In this study, elderly volunteers will be asked to ingest a supplement of a vegetable oil providing 1g of ALA, or an equivalent amount of linoleic acid as sunflower oil, for a diet period of 6 weeks.Serum samples will be collected before the dietary intervention and 6 weeks later.Plasma biomarkers of inflammatory, lipid cardiovascular risk factors and serum and red cell membrane fatty acid composition will be determined on all samples.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elderly patients over 65 years old exhibiting clinical indices of cardiovascular disease\n* Male or female\n* Subjects who were hospitalized in the Geriatric Unit of the Emile Roux Hospital (AP-HP)\n* MMSE (Mini Mental State Examination)score \\> or = 15\n* Supervision available for study medication\n* Able to ingest oral diet\n\nExclusion Criteria:\n\n* Patients unable to understand the objectives of the dietary intervention\n* Patients in paliative care\n* Patients receiving supplement diets'}, 'identificationModule': {'nctId': 'NCT03025620', 'briefTitle': 'Dietary Intake of Alpha-linolenic Acid in Elderly', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Investigation of the Relationship Between Alpha-linolenic Acid and Arterial, Biochemical, Biological Parameters in Older Persons With History of Cardiovascular Events and/or Moderate Cognitive Impairment', 'orgStudyIdInfo': {'id': 'Alphalinolenage'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Sunflower arm', 'description': 'Participants were supplied with the usual diet of the hospital, daily enriched with 17.5g fat as follows during 42 days: 10 g of sunflower oil (with a high content in linoleic acid) were added into the dinner soup and 7.5g delivered through a 12.5g portion of margarine made with sunflower oil (60% fat) that replaced butter on the breakfast toasts.', 'interventionNames': ['Dietary Supplement: Sunflower oil']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rapeseed arm', 'description': 'Participants were supplied with the usual diet of the hospital, daily enriched with 17.5g fat as follows during 42 days: 10 g of rapeseed oil (with a high content in alpha-linolenic acid) were added into the dinner soup and 7.5g delivered through a 12.5g portion of margarine made with rapeseed oil (60% fat) that replaced butter on the breakfast toasts.', 'interventionNames': ['Dietary Supplement: Rapeseed oil']}], 'interventions': [{'name': 'Rapeseed oil', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Alpha-linolenic acid'], 'description': 'Active comparator arm : Dietary Supplement: rapeseed oil supplementation (10g per day) and margarine with a high level of alpha-linolenic acid (12.5g per day) during 42 days.', 'armGroupLabels': ['Rapeseed arm']}, {'name': 'Sunflower oil', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Linoleic acid'], 'description': 'Placebo comparator arm : Dietary Supplement: sunflower oil supplementation (10g per day) and margarine with a high level of inoleic acid (12.5g per day) during 42 days.', 'armGroupLabels': ['Sunflower arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94450', 'city': 'Limeil-Brévannes', 'country': 'France', 'facility': 'hopital Emile Roux', 'geoPoint': {'lat': 48.7448, 'lon': 2.48705}}], 'overallOfficials': [{'name': 'olivier henry, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique de Paris. Hopital Emile Roux'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut Elevage', 'class': 'UNKNOWN'}, {'name': 'ITERG', 'class': 'INDUSTRY'}, {'name': 'SAINT HUBERT', 'class': 'UNKNOWN'}, {'name': 'TERRES UNIVIA', 'class': 'UNKNOWN'}, {'name': 'TERRES INOVIA', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Fathi Driss', 'investigatorAffiliation': 'Assistance Publique - Hôpitaux de Paris'}}}}