Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2026-03-06 @ 4:04 PM
Study NCT ID:
NCT02409927
Status:
COMPLETED
Last Update Posted:
2019-02-11
First Post:
2015-03-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of MCT Emulsification on Ketogenesis in Human Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007662', 'term': 'Ketosis'}], 'ancestors': [{'id': 'D000138', 'term': 'Acidosis'}, {'id': 'D000137', 'term': 'Acid-Base Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'stephen.cunnane@usherbrooke.ca', 'phone': '819-780-2220', 'title': 'Pr. Stephen Cunnane', 'phoneExt': '45670', 'organization': 'Université de Sherbrooke'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event date were collected during the 7 metabolic study day', 'eventGroups': [{'id': 'EG000', 'title': 'Healthy Participant', 'description': 'Each participant undergo 7 metabolic day, separate by at least 3 days, where they received a different dietary supplement on each day: control (no supplement), MCT oil 10g, MCT oil 20g, MCT oil 30g (provided from pure MCT oil), MCT homogenate 10g, MCT homogenate 20g, MCT homogenate 30g (provided by a 10% MCT homogenate emulsion)', 'otherNumAtRisk': 10, 'otherNumAffected': 4, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abnominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'gastric reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Plasma Ketone Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participant', 'description': 'Each participant undergo 7 metabolic day, separate by at least 3 days, where they received a different dietary supplement on each day: control (no supplement), MCT oil 10g, MCT oil 20g, MCT oil 30g (provided from pure MCT oil), MCT homogenate 10g, MCT homogenate 20g, MCT homogenate 30g (provided by a 10% MCT homogenate emulsion)'}], 'classes': [{'title': 'control', 'categories': [{'measurements': [{'value': '136.97', 'spread': '11.33', 'groupId': 'OG000'}]}]}, {'title': '10g MCT oil', 'categories': [{'measurements': [{'value': '177.43', 'spread': '14.711', 'groupId': 'OG000'}]}]}, {'title': '20 g MCT oil', 'categories': [{'measurements': [{'value': '270.61', 'spread': '27.477', 'groupId': 'OG000'}]}]}, {'title': '30 g MCT oil', 'categories': [{'measurements': [{'value': '249.3', 'spread': '17.474', 'groupId': 'OG000'}]}]}, {'title': '10g MCT homogenate', 'categories': [{'measurements': [{'value': '262.92', 'spread': '26.82', 'groupId': 'OG000'}]}]}, {'title': '20g MCT homogenate', 'categories': [{'measurements': [{'value': '277.25', 'spread': '30.006', 'groupId': 'OG000'}]}]}, {'title': '30 g MCT homogenate', 'categories': [{'measurements': [{'value': '244.74', 'spread': '65.83', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average of every 30 minutes for 4 hours following intake of supplement', 'description': 'Average of total ketones (beta-hydroxynutyrate + acetoacetate) measured in plasma, measured every 30 minutes for hours following intake of the different supplements', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plasma Glucose Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participant', 'description': 'Each participant undergo 7 metabolic day, separate by at least 3 days, where they received a different dietary supplement on each day: control (no supplement), MCT oil 10g, MCT oil 20g, MCT oil 30g (provided from pure MCT oil), MCT homogenate 10g, MCT homogenate 20g, MCT homogenate 30g (provided by a 10% MCT homogenate emulsion)'}], 'classes': [{'title': 'control', 'categories': [{'measurements': [{'value': '4.86', 'spread': '0.33', 'groupId': 'OG000'}]}]}, {'title': '10 g MCT oil', 'categories': [{'measurements': [{'value': '4.98', 'spread': '0.24', 'groupId': 'OG000'}]}]}, {'title': '20g MCT oil', 'categories': [{'measurements': [{'value': '4.97', 'spread': '0.28', 'groupId': 'OG000'}]}]}, {'title': '30g MCT oil', 'categories': [{'measurements': [{'value': '4.99', 'spread': '0.27', 'groupId': 'OG000'}]}]}, {'title': '10g MCT homogenate', 'categories': [{'measurements': [{'value': '5.01', 'spread': '0.26', 'groupId': 'OG000'}]}]}, {'title': '20g MCT homogenate', 'categories': [{'measurements': [{'value': '4.84', 'spread': '0.26', 'groupId': 'OG000'}]}]}, {'title': '30g MCT homogenate', 'categories': [{'measurements': [{'value': '5.09', 'spread': '0.22', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Average of every 30 minutes for 4 hours following intake of supplement', 'description': 'average of glucose measured every 30 minutes during the four hour of each metabolic day', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plasma Free Fatty Acids Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participant', 'description': 'Each participant undergo 7 metabolic day, separate by at least 3 days, where they received a different dietary supplement on each day: control (no supplement), MCT oil 10g, MCT oil 20g, MCT oil 30g (provided from pure MCT oil), MCT homogenate 10g, MCT homogenate 20g, MCT homogenate 30g (provided by a 10% MCT homogenate emulsion)'}], 'classes': [{'title': 'control', 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.05', 'groupId': 'OG000'}]}]}, {'title': '10g MCT oil', 'categories': [{'measurements': [{'value': '0.39', 'spread': '0.04', 'groupId': 'OG000'}]}]}, {'title': '20g MCT oil', 'categories': [{'measurements': [{'value': '0.41', 'spread': '0.04', 'groupId': 'OG000'}]}]}, {'title': '30 g MCT oil', 'categories': [{'measurements': [{'value': '0.38', 'spread': '0.05', 'groupId': 'OG000'}]}]}, {'title': '10g MCT homogenate', 'categories': [{'measurements': [{'value': '0.44', 'spread': '0.05', 'groupId': 'OG000'}]}]}, {'title': '20g MCT homogeante', 'categories': [{'measurements': [{'value': '0.41', 'spread': '0.05', 'groupId': 'OG000'}]}]}, {'title': '30g MCT homogenate', 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.06', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'average of 4 hours following intake of supplement', 'description': 'average of free fatty acids measured every 30 minutes during the four hour fo each metabolic day', 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plasma Insuline Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participant', 'description': 'Each participant undergo 7 metabolic day, separate by at least 3 days, where they received a different dietary supplement on each day: control (no supplement), MCT oil 10g, MCT oil 20g, MCT oil 30g (provided from pure MCT oil), MCT homogenate 10g, MCT homogenate 20g, MCT homogenate 30g (provided by a 10% MCT homogenate emulsion)'}], 'classes': [{'title': 'control', 'categories': [{'measurements': [{'value': '9.79', 'spread': '2.03', 'groupId': 'OG000'}]}]}, {'title': '10g MCT oil', 'categories': [{'measurements': [{'value': '13.7', 'spread': '3.43', 'groupId': 'OG000'}]}]}, {'title': '20 g MCT oil', 'categories': [{'measurements': [{'value': '10.88', 'spread': '2.01', 'groupId': 'OG000'}]}]}, {'title': '30 g MCT oil', 'categories': [{'measurements': [{'value': '13.00', 'spread': '2.58', 'groupId': 'OG000'}]}]}, {'title': '10g MCT homogenate', 'categories': [{'measurements': [{'value': '12.87', 'spread': '2.47', 'groupId': 'OG000'}]}]}, {'title': '20g MCT homogenate', 'categories': [{'measurements': [{'value': '11.94', 'spread': '2.84', 'groupId': 'OG000'}]}]}, {'title': '30g MCT homogenate', 'categories': [{'measurements': [{'value': '12.86', 'spread': '2.08', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'average of 4 hours following intake of supplement', 'description': 'Average of insulin measured evey 30 minutes during the 4 hours of each metabolic day', 'unitOfMeasure': 'µIU/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Side Effects for Each Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Participant', 'description': 'Each participant undergo 7 metabolic day, separate by at least 3 days, where they received a different dietary supplement on each day: control (no supplement), MCT oil 10g, MCT oil 20g, MCT oil 30g (provided from pure MCT oil), MCT homogenate 10g, MCT homogenate 20g, MCT homogenate 30g (provided by a 10% MCT homogenate emulsion)'}], 'classes': [{'title': 'control', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '10 g MCT oil', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '20 g MCT oil', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': '30 g MCT oil', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': '10 g MCT homogenate', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '20g MCT homogenate', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': '30g MCT homogenate', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 4 hours following intake of supplement', 'description': 'If participant had any side effect (mild or moderate) at least one time during the day.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Participant', 'description': 'Each participant undergo 7 metabolic day, separate by at least 3 days, where they received a different dietary supplement on each day: control (no supplement), MCT oil 10g, MCT oil 20g, MCT oil 30g (provided from pure MCT oil), MCT homogenate 10g, MCT homogenate 20g, MCT homogenate 30g (provided by a 10% MCT homogenate emulsion)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy', 'description': 'Participants involved in the project had seven metabolic study day to do : control day (no supplement), MCT oil 10,20 or 30 g, and MCT homogenate 10, 20 or 30 g. They were taking the supplement with a breakfast and there was blood sampling every 30 minutes.t'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31', 'spread': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Each participant underwent 7 metabolic day (1-day visit), each visit separate by a minimum of 3 day'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-28', 'studyFirstSubmitDate': '2015-03-27', 'resultsFirstSubmitDate': '2017-08-29', 'studyFirstSubmitQcDate': '2015-04-06', 'lastUpdatePostDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-06-11', 'studyFirstPostDateStruct': {'date': '2015-04-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma Ketone Concentration', 'timeFrame': 'Average of every 30 minutes for 4 hours following intake of supplement', 'description': 'Average of total ketones (beta-hydroxynutyrate + acetoacetate) measured in plasma, measured every 30 minutes for hours following intake of the different supplements'}], 'secondaryOutcomes': [{'measure': 'Plasma Glucose Concentration', 'timeFrame': 'Average of every 30 minutes for 4 hours following intake of supplement', 'description': 'average of glucose measured every 30 minutes during the four hour of each metabolic day'}, {'measure': 'Plasma Free Fatty Acids Concentration', 'timeFrame': 'average of 4 hours following intake of supplement', 'description': 'average of free fatty acids measured every 30 minutes during the four hour fo each metabolic day'}, {'measure': 'Plasma Insuline Concentration', 'timeFrame': 'average of 4 hours following intake of supplement', 'description': 'Average of insulin measured evey 30 minutes during the 4 hours of each metabolic day'}, {'measure': 'Number of Participants With Side Effects for Each Visit', 'timeFrame': 'During the 4 hours following intake of supplement', 'description': 'If participant had any side effect (mild or moderate) at least one time during the day.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Medium-chain triglycerides', 'Metabolism', 'Ketones', 'Lipids', 'Emulsification'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '29955713', 'type': 'DERIVED', 'citation': 'Courchesne-Loyer A, Lowry CM, St-Pierre V, Vandenberghe C, Fortier M, Castellano CA, Wagner JR, Cunnane SC. Emulsification Increases the Acute Ketogenic Effect and Bioavailability of Medium-Chain Triglycerides in Humans: Protein, Carbohydrate, and Fat Metabolism. Curr Dev Nutr. 2017 Jun 21;1(7):e000851. doi: 10.3945/cdn.117.000851. eCollection 2017 Jul.'}]}, 'descriptionModule': {'briefSummary': "Lower brain glucose uptake is present before the onset of cognitive deterioration and may increase the risk of cognitive decline in Alzheimer's disease. Ketones are the brain's main alternative energy substrates. Medium-chain triglycerides (MCT) are rapidly beta-oxidized and are ketogenic. Large doses of MCT oil are linked to gastro-intestinal side effects due to incomplete absorption so the investigators examined whether homogenisation into a skim milk matrix (MCT-H) would both improve ketogenesis and reduce side-effects compared to MCT taken without homogenisation into a matrix (bulk MCT \\[MCT-B\\]).\n\nHypotheses: (i) MCT-H will be better absorbed compared to MCT-B, so MCT-H will result in higher ketonemia and lower side effects in healthy adults. (ii) The effects of MCT-B and MCT-H on ketogenesis will be dose-dependent."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18 years or more\n\nExclusion Criteria:\n\n* smoker\n* pregnancy or breastfeeding\n* diabetes or insulin resistance\n* uncontrolled thyroid disease, hepatic or renal disease\n* uncontrolled high blood pressure\n* medical treatment influencing lipid or glucide metabolism\n* ongoing or past severe drug or alcohol abuse\n* dementia or psychiatric difficulties or depression\n* chronic immune condition or inflammation'}, 'identificationModule': {'nctId': 'NCT02409927', 'briefTitle': 'Effect of MCT Emulsification on Ketogenesis in Human Adults', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'Effect of Medium-chain Triglycerides Emulsification on Ketogenesis and Adverse Effects in Human Adults', 'orgStudyIdInfo': {'id': '2014-391'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Healthy participant', 'description': 'Each participant undergo 7 metabolic day, separate by at least 3 days, where they received a different dietary supplement on each day: control (no supplement), MCT oil 10g, MCT oil 20g, MCT oil 30g (provided from pure MCT oil), MCT homogenate 10g, MCT homogenate 20g, MCT homogenate 30g (provided by a 10% MCT homogenate emulsion)', 'interventionNames': ['Dietary Supplement: MCT oil 10g', 'Dietary Supplement: MCT homogenate 10g', 'Dietary Supplement: Control', 'Dietary Supplement: MCT oil 20g', 'Dietary Supplement: MCT homogenate 20g', 'Dietary Supplement: MCT oil 30g', 'Dietary Supplement: MCT homogenate 30g']}], 'interventions': [{'name': 'MCT oil 10g', 'type': 'DIETARY_SUPPLEMENT', 'description': '10 g of pure MCT oil mixed with skim milk in a standardized breakfast', 'armGroupLabels': ['Healthy participant']}, {'name': 'MCT homogenate 10g', 'type': 'DIETARY_SUPPLEMENT', 'description': '10g provided by 10% MCT homogenate mixed with skim milk in a standardized breakfast', 'armGroupLabels': ['Healthy participant']}, {'name': 'Control', 'type': 'DIETARY_SUPPLEMENT', 'description': 'vehicule (skim milk) with a standardized breakfast', 'armGroupLabels': ['Healthy participant']}, {'name': 'MCT oil 20g', 'type': 'DIETARY_SUPPLEMENT', 'description': '20g of pure MCT oil mixed with skim milk in a standardized breakfast', 'armGroupLabels': ['Healthy participant']}, {'name': 'MCT homogenate 20g', 'type': 'DIETARY_SUPPLEMENT', 'description': '20g provided by 10% MCT homogenate mixed with skim milk in a standardized breakfast', 'armGroupLabels': ['Healthy participant']}, {'name': 'MCT oil 30g', 'type': 'DIETARY_SUPPLEMENT', 'description': '30g of 100% pure MCT oil mixed with skim milk in a standardized breakfast', 'armGroupLabels': ['Healthy participant']}, {'name': 'MCT homogenate 30g', 'type': 'DIETARY_SUPPLEMENT', 'description': '30g provided by 10% MCT homogenate mixed with skim milk in a standardized breakfast', 'armGroupLabels': ['Healthy participant']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Stephen C Cunnane, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Université de Sherbrooke'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}