Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-01-18 @ 5:48 PM
Study NCT ID:
NCT02709356
Status:
COMPLETED
Last Update Posted:
2018-10-10
First Post:
2016-02-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medium Chain Triglycerides and Brain Metabolism in Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-09', 'studyFirstSubmitDate': '2016-02-01', 'studyFirstSubmitQcDate': '2016-03-10', 'lastUpdatePostDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantification of brain glucose uptake', 'timeFrame': '1-month', 'description': 'Brain glucose uptake (umol/100g/min) using 18-FDG PET scan'}, {'measure': 'Quantification of brain acetoacetate uptake', 'timeFrame': '1-month', 'description': 'Brain acetoacetate uptake (umol/100g/min) using 11C-AcAc PET scan'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': "Evaluate and compare the changes in brain ketone and glucose uptake after taking two different MCT oil emulsions (60-40 oil or C8 oil) for one month, in a group of people with Alzheimer's disease and a control group.", 'detailedDescription': "Based on a PET/MRI protocol, the aim of this study is to evaluate and compare the response to the dietary supplementation of two different MCT oils (60% C10 + 40% C8 or 100 % C8) in two groups, patients with Alzheimer's disease and healthy elderly people (N=10/group). After a baseline evaluation, participant will test one of the supplements during two successive periods of one month; each period of time ending with 18F-FDG and 11C-acetoacetate PET scans."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Good general health for Control group\n* Diagnosis of Alzheimer's disease (NINCDS-ADRDA criteria) for AD group\n\nExclusion Criteria:\n\n* Depression\n* Medical or psychiatric conditions that could interfere with study participation\n* Fasting plasma glucose ≥7.0 mM (diabetes or prediabetes)\n* Already on MCT supplementation\n* Clinically-significant gastrointestinal disease/conditions\n* Clinically-significant liver disease/dysfunction\n* Clinically-significant renal disease/dysfunction\n* Clinically-significant cardiac disease/conditions\n* Hypertension\n* Uncontrolled dyslipidaemia\n* Vitamin B12 deficiency\n* Structured physical activity (more than 3 times/week)"}, 'identificationModule': {'nctId': 'NCT02709356', 'acronym': 'MCT-MA', 'briefTitle': "Medium Chain Triglycerides and Brain Metabolism in Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': "Proof of Concepts: Can a Supplement Ketogenic Based MCT Oil Increases Cerebral Capture Ketones in People With Alzheimer's Disease?", 'orgStudyIdInfo': {'id': '2016-547'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "Alzheimer's disease", 'description': "Patients with mild Alzheimer's disease.\n\n1-month of 60-40 MCT oil and 1-month of C8 MCT oil (order of the two intervention are randomized)", 'interventionNames': ['Dietary Supplement: 1-month of 60-40 MCT oil', 'Dietary Supplement: 1-month of C8 MCT oil']}, {'type': 'EXPERIMENTAL', 'label': 'Controls', 'description': 'Healthy elderly people\n\n1-month of 60-40 MCT oil and 1-month of C8 MCT oil (order of the two intervention are randomized)', 'interventionNames': ['Dietary Supplement: 1-month of 60-40 MCT oil', 'Dietary Supplement: 1-month of C8 MCT oil']}], 'interventions': [{'name': '1-month of 60-40 MCT oil', 'type': 'DIETARY_SUPPLEMENT', 'description': '1-month supplementation of 30 g MCT oil (60% C10 + 40% C8)/day', 'armGroupLabels': ["Alzheimer's disease", 'Controls']}, {'name': '1-month of C8 MCT oil', 'type': 'DIETARY_SUPPLEMENT', 'description': '1-month supplementation of 30 g MCT oil (100% C8)/day (1-month of C8 MCT oïl)', 'armGroupLabels': ["Alzheimer's disease", 'Controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J1H4C4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': "Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)", 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'overallOfficials': [{'name': 'Stephen Cunnane, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS) - Université de Sherbrooke"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondation Vitae', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}