Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-24 @ 5:29 PM
Study NCT ID:
NCT03830268
Status:
COMPLETED
Last Update Posted:
2020-03-25
First Post:
2019-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acute Medium Chain Triglycerides (MCT) Intake in Young and Older Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007662', 'term': 'Ketosis'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062408', 'term': 'Breakfast'}, {'id': 'D062409', 'term': 'Lunch'}], 'ancestors': [{'id': 'D062407', 'term': 'Meals'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '10 young and 10 older participants undergoing six separate but identical metabolic visits (interventions)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-24', 'studyFirstSubmitDate': '2019-02-01', 'studyFirstSubmitQcDate': '2019-02-04', 'lastUpdatePostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of plasma ketones (acetoacetate and B-hydroxybutyrate)', 'timeFrame': '8 hours', 'description': 'To compare acute ketonemia following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol.'}], 'secondaryOutcomes': [{'measure': 'Concentration of plasma glucose', 'timeFrame': '8 hours', 'description': 'To compare acute glucose following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol.'}, {'measure': 'Concentration of plasma insulin', 'timeFrame': '8 hours', 'description': 'To compare acute insulin following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol.'}, {'measure': 'Concentration of plasma free fatty acids', 'timeFrame': '8 hours', 'description': 'To compare acute free fatty acids following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ketones', 'Medium Chain Triglycerides', 'Glucose', 'Insulin', 'Free fatty acids'], 'conditions': ['Ketonemia']}, 'referencesModule': {'references': [{'pmid': '26766547', 'type': 'BACKGROUND', 'citation': "Cunnane SC, Courchesne-Loyer A, St-Pierre V, Vandenberghe C, Pierotti T, Fortier M, Croteau E, Castellano CA. Can ketones compensate for deteriorating brain glucose uptake during aging? Implications for the risk and treatment of Alzheimer's disease. Ann N Y Acad Sci. 2016 Mar;1367(1):12-20. doi: 10.1111/nyas.12999. Epub 2016 Jan 14."}, {'pmid': '28709938', 'type': 'BACKGROUND', 'citation': "Croteau E, Castellano CA, Fortier M, Bocti C, Fulop T, Paquet N, Cunnane SC. A cross-sectional comparison of brain glucose and ketone metabolism in cognitively healthy older adults, mild cognitive impairment and early Alzheimer's disease. Exp Gerontol. 2018 Jul 1;107:18-26. doi: 10.1016/j.exger.2017.07.004. Epub 2017 Jul 12."}, {'pmid': '27629100', 'type': 'BACKGROUND', 'citation': 'Courchesne-Loyer A, Croteau E, Castellano CA, St-Pierre V, Hennebelle M, Cunnane SC. Inverse relationship between brain glucose and ketone metabolism in adults during short-term moderate dietary ketosis: A dual tracer quantitative positron emission tomography study. J Cereb Blood Flow Metab. 2017 Jul;37(7):2485-2493. doi: 10.1177/0271678X16669366. Epub 2016 Jan 1.'}, {'pmid': '23274095', 'type': 'BACKGROUND', 'citation': 'Courchesne-Loyer A, Fortier M, Tremblay-Mercier J, Chouinard-Watkins R, Roy M, Nugent S, Castellano CA, Cunnane SC. Stimulation of mild, sustained ketonemia by medium-chain triacylglycerols in healthy humans: estimated potential contribution to brain energy metabolism. Nutrition. 2013 Apr;29(4):635-40. doi: 10.1016/j.nut.2012.09.009. Epub 2012 Dec 28.'}, {'pmid': '25147107', 'type': 'BACKGROUND', 'citation': "Castellano CA, Nugent S, Paquet N, Tremblay S, Bocti C, Lacombe G, Imbeault H, Turcotte E, Fulop T, Cunnane SC. Lower brain 18F-fluorodeoxyglucose uptake but normal 11C-acetoacetate metabolism in mild Alzheimer's disease dementia. J Alzheimers Dis. 2015;43(4):1343-53. doi: 10.3233/JAD-141074."}]}, 'descriptionModule': {'briefSummary': 'Compare plasma metabolites following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol in young and older participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 10 health young (20-40 y old) and 10 health older (\\> 60 y old) participants\n* Men and women\n\nExclusion Criteria:\n\n* smoking\n* diabetes (fasting glucose \\>7.0 mmol/l and glycated hemoglobin \\>6.9%)\n* strenuous aerobic exercise more than three times a week\n* untreated hypertension, dyslipidemia, and abnormal renal, liver, heart or thyroid function\n* under medication known to affect triglycerides and carbohydrates metabolism (i.e. diuretics, beta-blockers, steroids, insulin sensitizing)'}, 'identificationModule': {'nctId': 'NCT03830268', 'acronym': 'Opti-MCT', 'briefTitle': 'Acute Medium Chain Triglycerides (MCT) Intake in Young and Older Participants', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'Optimisation of Acute Medium Chain Triglycerides Intake Characteristics on Different Plasma Metabolites in Young and Older Participants', 'orgStudyIdInfo': {'id': '2017-714'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MCT intake in young participants', 'description': 'Different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol in young participants.\n\nInterventions:\n\n1. No MCT intake with breakfast, no lunch (i.e. CTL)\n2. No MCT intake with lunch, no breakfast (i.e CTL inverted)\n3. 10g of Betaquik with breakfast, no lunch (i.e BQ10)\n4. 20g of Betaquik with breakfast, no lunch (i.e BQ20)\n5. 10g of Betaquik with low-carbs breakfast, no lunch (i.e BQ10LC)\n6. 10g of Betaquik with lunch, no breakfast (i.e BQ10 inverted)', 'interventionNames': ['Dietary Supplement: No MCT intake with breakfast, no lunch', 'Dietary Supplement: No MCT intake with lunch, no breakfast', 'Dietary Supplement: 10g of Betaquik', 'Dietary Supplement: 10g of Betaquik with low-carbs breakfast', 'Dietary Supplement: 20g of Betaquik', 'Dietary Supplement: 10g of Betaquik with lunch, no breakfast']}, {'type': 'EXPERIMENTAL', 'label': 'MCT intake in older participants', 'description': 'Different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol in older participants.\n\nInterventions:\n\n1. No MCT intake with breakfast, no lunch (i.e. CTL)\n2. No MCT intake with lunch, no breakfast (i.e CTL inverted)\n3. 10g of Betaquik with breakfast, no lunch (i.e BQ10)\n4. 20g of Betaquik with breakfast, no lunch (i.e BQ20)\n5. 10g of Betaquik with low-carbs breakfast, no lunch (i.e BQ10LC)\n6. 10g of Betaquik with lunch, no breakfast (i.e BQ10 inverted)', 'interventionNames': ['Dietary Supplement: 10g of Betaquik']}], 'interventions': [{'name': 'No MCT intake with breakfast, no lunch', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['CTL'], 'description': 'Water given with a regular standardize breakfast and water given at noon without lunch.', 'armGroupLabels': ['MCT intake in young participants']}, {'name': 'No MCT intake with lunch, no breakfast', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['CTL inverted'], 'description': 'Water given in the beginning of the metabolic study day without breakfast and water given at noon with a regular standardize lunch.', 'armGroupLabels': ['MCT intake in young participants']}, {'name': '10g of Betaquik', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['BQ10'], 'description': 'BQ10 given with a regular standardize breakfast and BQ10 given at noon without lunch.', 'armGroupLabels': ['MCT intake in older participants', 'MCT intake in young participants']}, {'name': '10g of Betaquik with low-carbs breakfast', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['BQ10LC'], 'description': 'BQ10 given with a low-carbs standardize breakfast and BQ10 given at noon without lunch.', 'armGroupLabels': ['MCT intake in young participants']}, {'name': '20g of Betaquik', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['BQ20'], 'description': 'BQ20 given with a regular standardize breakfast and BQ20 given at noon without lunch.', 'armGroupLabels': ['MCT intake in young participants']}, {'name': '10g of Betaquik with lunch, no breakfast', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['BQ10 inverted'], 'description': 'BQ10 given in the beginning of the metabolic study day without breakfast and BQ10 given at noon with a regular standardize lunch.', 'armGroupLabels': ['MCT intake in young participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J1H4C4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Rearsh Centre on Aging', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}