Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2025-12-27 @ 9:55 PM
Study NCT ID:
NCT04322461
Status:
COMPLETED
Last Update Posted:
2025-06-03
First Post:
2020-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Exercise, Endocannabinoids and Ketones on Cerebral Metabolism in a Cognitive Disorders Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D007662', 'term': 'Ketosis'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-05-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-28', 'studyFirstSubmitDate': '2020-03-24', 'studyFirstSubmitQcDate': '2020-03-24', 'lastUpdatePostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognition', 'timeFrame': '2 months, evaluation before and after intervention', 'description': 'Measure of cognition with CANTAB'}, {'measure': 'Ketones', 'timeFrame': '2 months, evaluation before and after intervention', 'description': 'Measurement of ketones concentrations'}], 'secondaryOutcomes': [{'measure': 'Endocannabinoids', 'timeFrame': '2 months, evaluation before and after intervention', 'description': 'Endocannabinoids plasma concentration'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alzheimer', 'Parkinson', 'Ketones', 'medium chain triglycerides', 'cognition', 'brain'], 'conditions': ['Parkinson Disease', 'Alzheimer Disease']}, 'descriptionModule': {'briefSummary': "A two months intervention in which two groups of cognitive disorders, Parkinson and Alzheimer's disease, will receive 50g/day of a commercial MCT supplement combined with supervised aerobic exercise 3 times/week. Cognition and ketones will be assess before and after the intervention, along with endocannabinoids plasma concentrations."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Alzheimer's or parkinson disease diagnostic\n* Stable medication associated with the disease\n* Able to consent\n* Presence of an accompanying person for the first and last visit.\n* Ability to read and talk in French\n\nExclusion Criteria:\n\n* MMSE \\< 20\n* MCT or coconut oil supplementation\n* Coconut allergy\n* Cannabis, THC or CBD consumption\n* Excessive alcohol consumption\n* Physical activity 3x/week\n* Presence of an metallic object in the body\n* Impossibility to lay in dorsal decubitus for 40 minutes\n* Cardiac disease\n* Any uncontrolled disease that could interfer with the project."}, 'identificationModule': {'nctId': 'NCT04322461', 'acronym': 'PARKA', 'briefTitle': 'Effect of Exercise, Endocannabinoids and Ketones on Cerebral Metabolism in a Cognitive Disorders Population', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'Effect of Exercise, Endocannabinoids and Ketones on Cerebral Metabolism in a Cognitive Disorders Population : Pilot Project PARKA', 'orgStudyIdInfo': {'id': '2020-3436'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Parkinson disease', 'description': '2 months intervention with 50g/day of a commercial MCT supplement combine with supervised aerobic exercise 3x/week.', 'interventionNames': ['Dietary Supplement: Betaquik MCT supplement']}, {'type': 'EXPERIMENTAL', 'label': "Alzheimer's disease", 'description': '2 months intervention with 50g/day of a commercial MCT supplement combine with supervised aerobic exercise 3x/week.', 'interventionNames': ['Dietary Supplement: Betaquik MCT supplement']}], 'interventions': [{'name': 'Betaquik MCT supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': '50g/day divided in 3. Breakfast, lunch and dinner', 'armGroupLabels': ["Alzheimer's disease", 'Parkinson disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J1H 4C4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre de recherche sur le vieillissement', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'overallOfficials': [{'name': 'Stephen Cunnane, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Sherbrooke'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'collaborators': [{'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}