Ignite Creation Date:
2025-12-26 @ 5:18 PM
Ignite Modification Date:
2026-03-04 @ 1:36 PM
Study NCT ID:
NCT02693106
Status:
COMPLETED
Last Update Posted:
2020-03-25
First Post:
2016-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Ketogenic Potential of Different Diet Supplements
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007930', 'term': 'Leucine'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'C031492', 'term': 'octanoic acid'}, {'id': 'D002331', 'term': 'Carnitine'}], 'ancestors': [{'id': 'D000597', 'term': 'Amino Acids, Branched-Chain'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005232', 'term': 'Fatty Acids, Volatile'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, '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': '8 visits of 4 hours', 'description': 'no participants received the intervention if 65 g of butter fraction rich in MCT', 'eventGroups': [{'id': 'EG000', 'title': 'Control, no Supplement', 'description': 'Each visit corresponding to a standardize breakfast taken alone (control visit)followed by a period of 4-hour with multiple blood sampling.', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '5g of Leucine', 'description': 'Each visit corresponding to a standardize breakfast taken with 5g of leucine followed by a period of 4-hour with multiple blood sampling.', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '3.6g de Butyrate', 'description': 'Each visit corresponding to a standardize breakfast taken with 3.6g of butyrate followed by a period of 4-hour with multiple blood sampling.', 'otherNumAtRisk': 10, 'otherNumAffected': 2, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '7.2g de Butyrate', 'description': 'Each visit corresponding to a standardize breakfast taken with 7.2g of butyrate followed by a period of 4-hour with multiple blood sampling.', 'otherNumAtRisk': 10, 'otherNumAffected': 3, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': "5g d'Octanoate", 'description': 'Each visit corresponding to a standardize breakfast taken with 5g of octanoate followed by a period of 4-hour with multiple blood sampling.', 'otherNumAtRisk': 10, 'otherNumAffected': 2, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': "10g d'Octanoate", 'description': 'Each visit corresponding to a standardize breakfast taken with 10g of octanoate followed by a period of 4-hour with multiple blood sampling.', 'otherNumAtRisk': 10, 'otherNumAffected': 3, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': '1.95g de Carnitine', 'description': 'Each visit corresponding to a standardize breakfast taken with 1.95g of carnitine followed by a period of 4-hour with multiple blood sampling.', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'gastric reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Concentration of Total Plasma Ketones', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ketogenic Potential', 'description': 'Each participant has to go through a total of 8 visits, each visit corresponding to a standardize breakfast taken alone (control visit) or with one of the dietary supplements evaluated followed by a period of 4-hour with multiple blood sampling.\n\nIntervention 1: Control; no supplement Intervention 2: 5 g of leucine Intervention 3: 3.6 g of butyrate Intervention 4: 7.2 g of butyrate Intervention 5: 5 g of octanoate Intervention 6: 10 g of octanoate Intervention 7: 1.95 g of carnitine Intervention 8: 65 g of butter fraction rich in MCT'}], 'classes': [{'title': 'CTL', 'categories': [{'measurements': [{'value': '-18.2', 'spread': '20', 'groupId': 'OG000'}]}]}, {'title': 'Leucine', 'categories': [{'measurements': [{'value': '23', 'spread': '25', 'groupId': 'OG000'}]}]}, {'title': 'Butyrate 3.6g', 'categories': [{'measurements': [{'value': '12.2', 'spread': '44.4', 'groupId': 'OG000'}]}]}, {'title': 'Butyrate 7.2g', 'categories': [{'measurements': [{'value': '68.5', 'spread': '35.9', 'groupId': 'OG000'}]}]}, {'title': 'Octanoate 5g', 'categories': [{'measurements': [{'value': '-3.4', 'spread': '32.8', 'groupId': 'OG000'}]}]}, {'title': 'Octanoate 10 g', 'categories': [{'measurements': [{'value': '39.7', 'spread': '34', 'groupId': 'OG000'}]}]}, {'title': 'Carnitine', 'categories': [{'measurements': [{'value': '-30', 'spread': '21.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 hours', 'description': "Difference from Time 0 in Total ketones = acetoacetate (umol/L) + beta-hydroxybutyrate (umol/L) Time 0 is when the participants arrived, after a 12 hours fast, i.e. before the breakfast.\n\nPlasma was collected every 30 minutes for 4 hours immediately following breakfast (where supplements were taken).\n\nResults are the mean of plasma ketones measured every 30 minutes ( i.e. total of 9 plasma samples) for the 4 hour period.\n\nFor each time point, the difference form time 0 has been made. So this is the mean of the difference from time 0 in total ketones.\n\nData were not collected for the 'Intervention 8: 65 g of butter fraction rich in MCT' supplement.", 'unitOfMeasure': 'µmol/L', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ketogenic Potential', 'description': 'Each participant has to go through a total of 8 visits, each visit corresponding to a standardize breakfast taken alone (control visit) or with one of the dietary supplements evaluated followed by a period of 4-hour with multiple blood sampling.\n\nIntervention 1: Control; no supplement Intervention 2: 5 g of leucine Intervention 3: 3.6 g of butyrate Intervention 4: 7.2 g of butyrate Intervention 5: 5 g of octanoate Intervention 6: 10 g of octanoate Intervention 7: 1.95 g of carnitine Intervention 8: 65 g of butter fraction rich in MCT'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'No time', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ketogenic Potential', 'description': 'Each participant has to go through a total of 8 visits, each visit corresponding to a standardize breakfast taken alone (control visit) or with one of the dietary supplements evaluated followed by a period of 4-hour with multiple blood sampling.\n\nIntervention 1: Control; no supplement Intervention 2: 5 g of leucine Intervention 3: 3.6 g of butyrate Intervention 4: 7.2 g of butyrate Intervention 5: 5 g of octanoate Intervention 6: 10 g of octanoate Intervention 7: 1.95 g of carnitine Intervention 8: 65 g of butter fraction rich in MCT'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34', 'spread': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-24', 'studyFirstSubmitDate': '2016-02-23', 'resultsFirstSubmitDate': '2017-08-27', 'studyFirstSubmitQcDate': '2016-02-23', 'lastUpdatePostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-24', 'studyFirstPostDateStruct': {'date': '2016-02-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Concentration of Total Plasma Ketones', 'timeFrame': '4 hours', 'description': "Difference from Time 0 in Total ketones = acetoacetate (umol/L) + beta-hydroxybutyrate (umol/L) Time 0 is when the participants arrived, after a 12 hours fast, i.e. before the breakfast.\n\nPlasma was collected every 30 minutes for 4 hours immediately following breakfast (where supplements were taken).\n\nResults are the mean of plasma ketones measured every 30 minutes ( i.e. total of 9 plasma samples) for the 4 hour period.\n\nFor each time point, the difference form time 0 has been made. So this is the mean of the difference from time 0 in total ketones.\n\nData were not collected for the 'Intervention 8: 65 g of butter fraction rich in MCT' supplement."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ketones', 'Butyrate', 'Leucine', 'Octanoate', 'Carnitine', 'Medium Chain Triglycerides'], 'conditions': ['Healthy Adults']}, 'descriptionModule': {'briefSummary': 'Evaluate the capacity of different dietary supplements to increase ketone production in healthy adults.', 'detailedDescription': 'The aim of this study is to evaluate the capacity of different dietary supplements to increase ketone production in healthy adults. Each supplement (leucine, butyrate, octanoate, carnitine or butter fraction rich in MCT) is evaluated for a period of 4-hour during which multiple blood samples are taken in order to measure ketone production.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults aged of 18 years old or older.\n* Non-smoking.\n\nExclusion Criteria:\n\n* Diabetes or prediabetes\n* Uncontrolled hypertension\n* Uncontrolled thyroid function\n* Taking medication that will affect lipid/glucose metabolism\n* Severe infection or inflammation\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02693106', 'briefTitle': 'Evaluation of the Ketogenic Potential of Different Diet Supplements', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'Stimulating the Ketogenesis by Using Nutritional Supplements', 'orgStudyIdInfo': {'id': '2014-387'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketogenic potential', 'description': 'Each participant has to go through a total of 8 visits, each visit corresponding to a standardize breakfast taken alone (control visit) or with one of the dietary supplements evaluated followed by a period of 4-hour with multiple blood sampling.\n\nIntervention 1: Control; no supplement Intervention 2: 5 g of leucine Intervention 3: 3.6 g of butyrate Intervention 4: 7.2 g of butyrate Intervention 5: 5 g of octanoate Intervention 6: 10 g of octanoate Intervention 7: 1.95 g of carnitine Intervention 8: 65 g of butter fraction rich in MCT', 'interventionNames': ['Dietary Supplement: Control', 'Dietary Supplement: Leucine', 'Dietary Supplement: Butyrate -', 'Dietary Supplement: Butyrate +', 'Dietary Supplement: Octanoate -', 'Dietary Supplement: Octanoate +', 'Dietary Supplement: Carnitine', 'Dietary Supplement: Butter fraction']}], 'interventions': [{'name': 'Control', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['CTL'], 'description': 'Visit corresponding to a standardize breakfast taken alone (control visit) followed by a period of 4-hour with multiple blood sampling.', 'armGroupLabels': ['Ketogenic potential']}, {'name': 'Leucine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Visit corresponding to a standardize breakfast with 5 g of leucine followed by a period of 4-hour with multiple blood sampling.', 'armGroupLabels': ['Ketogenic potential']}, {'name': 'Butyrate -', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Visit corresponding to a standardize breakfast with 3.6 g of butyrate followed by a period of 4-hour with multiple blood sampling.', 'armGroupLabels': ['Ketogenic potential']}, {'name': 'Butyrate +', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Visit corresponding to a standardize breakfast with 7.2 g of butyrate followed by a period of 4-hour with multiple blood sampling.', 'armGroupLabels': ['Ketogenic potential']}, {'name': 'Octanoate -', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Visit corresponding to a standardize breakfast with 5 g of octanoate followed by a period of 4-hour with multiple blood sampling.', 'armGroupLabels': ['Ketogenic potential']}, {'name': 'Octanoate +', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Visit corresponding to a standardize breakfast with 10 g of octanoate followed by a period of 4-hour with multiple blood sampling.', 'armGroupLabels': ['Ketogenic potential']}, {'name': 'Carnitine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Visit corresponding to a standardize breakfast with 1.95 g of carnitine followed by a period of 4-hour with multiple blood sampling.', 'armGroupLabels': ['Ketogenic potential']}, {'name': 'Butter fraction', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Visit corresponding to a standardize breakfast with 65 g of butter fraction followed by a period of 4-hour with multiple blood sampling.', 'armGroupLabels': ['Ketogenic potential']}]}, '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"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}