Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT00746005
Status:
COMPLETED
Last Update Posted:
2011-01-12
First Post:
2008-08-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Fish Oil Supplementation on Cognition in MCI Patients and the Influence of the APOE4 Allele
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D000074242', 'term': 'Sunflower Oil'}], 'ancestors': [{'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D010938', 'term': 'Plant Oils'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, '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': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-11', 'studyFirstSubmitDate': '2008-08-30', 'studyFirstSubmitQcDate': '2008-09-02', 'lastUpdatePostDateStruct': {'date': '2011-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cognitive performance', 'timeFrame': 'baseline and after 4 weeks'}], 'secondaryOutcomes': [{'measure': 'blood flow-velocity in the middle cerebral arteries (assessed with TCD) and cortical tissue oxygenation, cerebral autoregulation, cerebral blood volume (assessed with NIRS', 'timeFrame': 'baseline and after 4 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mild cognitive impairment'], 'conditions': ['Mild Cognitive Impairment']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.humannutrition.nl', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To study the short term effects of a pharmacological dose of fish oil on cognitive performance and on cerebral blood flow. Furthermore, we want to investigate whether carriers of the APOEε4 allele respond differently to fish oil treatment compared to non-carriers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women\n* Diagnosed as having amnestic MCI: based on specific memory disturbances (cut-off of 1 sd, single or multiple domain amnestic MCI, according to Busse A et al37)\n* Presence of a principal caregiver willing to assist for a successful participation\n* Informed consent signed\n\nExclusion Criteria:\n\n* Current or recent (\\<4 weeks) use of fish oil supplements\n* Consumption of fish more than 2 times/week\n* Current use of dementia (Alzheimer) medication\n* Current use of acenocoumarol or other anti-thrombotic drugs (because of the high dose of fish oil)\n* Serious liver disease\n* Use of more than 4 glasses of alcohol per day\n* Unable to participate as judged by the responsible medical physician\n* Allergy to fish(oil)\n* Swallowing problems\n* Participation in another clinical trial less than 2 months before the start of the trial or at the same time'}, 'identificationModule': {'nctId': 'NCT00746005', 'briefTitle': 'Efficacy of Fish Oil Supplementation on Cognition in MCI Patients and the Influence of the APOE4 Allele', 'organization': {'class': 'OTHER', 'fullName': 'Wageningen University'}, 'officialTitle': 'Challenge Study: The Efficacy of Fish Oil Supplementation on Cognitive Performance in MCI Patients and the Influence of the APOE-epsilon4 Allele', 'orgStudyIdInfo': {'id': '2008/112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '3 g EPA-DHA', 'interventionNames': ['Dietary Supplement: fish oil']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo: sunflower oil', 'interventionNames': ['Dietary Supplement: placebo, sunflower oil']}], 'interventions': [{'name': 'fish oil', 'type': 'DIETARY_SUPPLEMENT', 'description': '3 g fish oil (3078 mg) total EPA 1512 mg and total DHA 1026 mg', 'armGroupLabels': ['1']}, {'name': 'placebo, sunflower oil', 'type': 'DIETARY_SUPPLEMENT', 'description': '3 g of sunflower oil', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6710 HN', 'city': 'Ede', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Ziekenhuis Gelderse Vallei', 'geoPoint': {'lat': 52.03333, 'lon': 5.65833}}, {'zip': '6525 GC', 'city': 'Nijmegen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Radboud University Medical Center', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wageningen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Radboud University Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Lisette de Groot', 'oldOrganization': 'Wageningen University'}}}}