Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-02-25 @ 10:04 PM
Study NCT ID:
NCT02679235
Status:
COMPLETED
Last Update Posted:
2020-07-23
First Post:
2016-02-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Brain Energy and Aging With Triheptanoin
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'stephen.cunnane@usherbrooke.ca', 'phone': '819-780-2220', 'title': 'Stephen Cunnane', 'phoneExt': '45670', 'organization': 'University of Sherbrooke'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During 4 week supplementation period', 'eventGroups': [{'id': 'EG000', 'title': 'Triheptanoin', 'description': 'Participant will undergo POST Triheptanoin suppementation 1g/kg body weight for 28 days (dose gradually increased each week, starting at, 0.25, 0.5, 0.75 and then 1 g) separated in 4 doses (with eah meal and before night) after a control PRE supplementation imaging protocol.\n\nPOST Triheptanoin: The target daily dose of triheptanoin will be 1 g/kg/d, or approximately 70 g/d during 28±2 days. It will be divided into four daily doses, one of which will be consumed at each meal and one with an evening snack.\n\ncontrol PRE supplementation: Before supplementation, same participants will undergo imaging protocol as a control condition. Participant will be asked to follow daily normal routine, without any change in medication or food habit.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 1, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'severe stomach pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Global Change in Brain Glucose Uptake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triheptanoin', 'description': 'Participant will undergo POST Triheptanoin suppementation 1g/kg body weight for 28 days (dose gradually increased each week, starting at, 0.25, 0.5, 0.75 and then 1 g) separated in 4 doses (with eah meal and before night) after a control PRE supplementation imaging protocol.\n\nPOST Triheptanoin: The target daily dose of triheptanoin will be 1 g/kg/d, or approximately 70 g/d during 28±2 days. It will be divided into four daily doses, one of which will be consumed at each meal and one with an evening snack.\n\ncontrol PRE supplementation: Before supplementation, same participants will undergo imaging protocol as a control condition. Participant will be asked to follow daily normal routine, without any change in medication or food habit.'}], 'classes': [{'title': 'PRE', 'categories': [{'measurements': [{'value': '30.3', 'spread': '1.7', 'groupId': 'OG000'}]}]}, {'title': 'POST supplementation', 'categories': [{'measurements': [{'value': '30.4', 'spread': '3.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28±2 days', 'description': 'Global change (average of cortex) in brain glucose uptake as measured by 18F-FDG PET scans PRE vs POST 28±2 days of supplementation', 'unitOfMeasure': 'μmol/100 g/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Global Change in Brain Ketone Uptake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triheptanoin', 'description': 'Participant will undergo POST Triheptanoin suppementation 1g/kg body weight for 28 days (dose gradually increased each week, starting at, 0.25, 0.5, 0.75 and then 1 g) separated in 4 doses (with eah meal and before night) after a control PRE supplementation imaging protocol.\n\nPOST Triheptanoin: The target daily dose of triheptanoin will be 1 g/kg/d, or approximately 70 g/d during 28±2 days. It will be divided into four daily doses, one of which will be consumed at each meal and one with an evening snack.\n\ncontrol PRE supplementation: Before supplementation, same participants will undergo imaging protocol as a control condition. Participant will be asked to follow daily normal routine, without any change in medication or food habit.'}], 'classes': [{'title': 'PRE', 'categories': [{'measurements': [{'value': '0.58', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'POST supplementation', 'categories': [{'measurements': [{'value': '0.26', 'spread': '0.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28±2 days', 'description': 'Global change in brain ketone uptake as measured by 11C-acetoacetate PET scans', 'unitOfMeasure': 'μmol/100 g/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Brain Volumes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triheptanoin', 'description': 'Participant will undergo POST Triheptanoin suppementation 1g/kg body weight for 28 days (dose gradually increased each week, starting at, 0.25, 0.5, 0.75 and then 1 g) separated in 4 doses (with eah meal and before night) after a control PRE supplementation imaging protocol.\n\nPOST Triheptanoin: The target daily dose of triheptanoin will be 1 g/kg/d, or approximately 70 g/d during 28±2 days. It will be divided into four daily doses, one of which will be consumed at each meal and one with an evening snack.\n\ncontrol PRE supplementation: Before supplementation, same participants will undergo imaging protocol as a control condition. Participant will be asked to follow daily normal routine, without any change in medication or food habit.'}], 'classes': [{'title': 'hipocampus PRE', 'categories': [{'measurements': [{'value': '7.4', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'hipocampus POST supplementation', 'categories': [{'measurements': [{'value': '7.4', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'Amygdala PRE', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Amygdala POST supplementation', 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Thalamus PRE', 'categories': [{'measurements': [{'value': '12.8', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'Thalamus POST suplementation', 'categories': [{'measurements': [{'value': '12.5', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Caudate PRE', 'categories': [{'measurements': [{'value': '6.9', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Caudate POST supplementation', 'categories': [{'measurements': [{'value': '6.8', 'spread': '0.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28±2 days', 'description': 'Structural imaging by T1-weighted MRI to measure brain volume', 'unitOfMeasure': 'ml/100 g/ min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'data was not available for 2 participants'}, {'type': 'SECONDARY', 'title': 'Change in Cerebral Blood Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Triheptanoin', 'description': 'Participant will undergo POST Triheptanoin suppementation 1g/kg body weight for 28 days (dose gradually increased each week, starting at, 0.25, 0.5, 0.75 and then 1 g) separated in 4 doses (with eah meal and before night) after a control PRE supplementation imaging protocol.\n\nPOST Triheptanoin: The target daily dose of triheptanoin will be 1 g/kg/d, or approximately 70 g/d during 28±2 days. It will be divided into four daily doses, one of which will be consumed at each meal and one with an evening snack.\n\ncontrol PRE supplementation: Before supplementation, same participants will undergo imaging protocol as a control condition. Participant will be asked to follow daily normal routine, without any change in medication or food habit.'}], 'classes': [{'title': 'PRE', 'categories': [{'measurements': [{'value': '41.8', 'spread': '9.1', 'groupId': 'OG000'}]}]}, {'title': 'POST supplementation', 'categories': [{'measurements': [{'value': '41.8', 'spread': '9.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28±2 days', 'description': 'change in cerebral blood flow measured by arterial spin labeling (ASL) and calculated using a one-compartment model (average cortex)', 'unitOfMeasure': 'ml/100 g/ min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Triheptanoin', 'description': 'Participant will undergo POST Triheptanoin suppementation 1g/kg body weight for 28 days (dose gradually increased each week, starting at, 0.25, 0.5, 0.75 and then 1 g) separated in 4 doses (with eah meal and before night) after a control PRE supplementation imaging protocol.\n\nPOST Triheptanoin: The target daily dose of triheptanoin will be 1 g/kg/d, or approximately 70 g/d during 28±2 days. It will be divided into four daily doses, one of which will be consumed at each meal and one with an evening snack.\n\ncontrol PRE supplementation: Before supplementation, same participants will undergo imaging protocol as a control condition. Participant will be asked to follow daily normal routine, without any change in medication or food habit.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Triheptanoin', 'description': 'Participant will undergo POST Triheptanoin suppementation 1g/kg body weight for 28 days (dose gradually increased each week, starting at, 0.25, 0.5, 0.75 and then 1 g) separated in 4 doses (with eah meal and before night) after a control PRE supplementation imaging protocol.\n\nPOST Triheptanoin: The target daily dose of triheptanoin will be 1 g/kg/d, or approximately 70 g/d during 28±2 days. It will be divided into four daily doses, one of which will be consumed at each meal and one with an evening snack.\n\ncontrol PRE supplementation: Before supplementation, same participants will undergo imaging protocol as a control condition. Participant will be asked to follow daily normal routine, without any change in medication or food habit.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '69.9', 'spread': '2.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': "Glucose uptake changes estimated by comparing participants' measurements to imaging standards of hea", 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '-14.8', 'spread': '3.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '% of difference compare to young control', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Education', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '16.5', 'spread': '3.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Montreal Cognitive Assessment (MoCA)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '27.3', 'spread': '2.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Assessment of cognition. The scale ranges from 0 to 30 points, with higher scores representing better cognitive ability', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'body mass index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '26.4', 'spread': '5.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Only the 11 participants which have completed the intervention are included in the baseline analysis'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-04', 'size': 763870, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-02-14T13:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The participant will receive THN treatment, compared to PRE supplementation condition.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-07', 'studyFirstSubmitDate': '2016-02-01', 'resultsFirstSubmitDate': '2019-02-14', 'studyFirstSubmitQcDate': '2016-02-05', 'lastUpdatePostDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-02', 'studyFirstPostDateStruct': {'date': '2016-02-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global Change in Brain Glucose Uptake', 'timeFrame': '28±2 days', 'description': 'Global change (average of cortex) in brain glucose uptake as measured by 18F-FDG PET scans PRE vs POST 28±2 days of supplementation'}, {'measure': 'Global Change in Brain Ketone Uptake', 'timeFrame': '28±2 days', 'description': 'Global change in brain ketone uptake as measured by 11C-acetoacetate PET scans'}], 'secondaryOutcomes': [{'measure': 'Change in Brain Volumes', 'timeFrame': '28±2 days', 'description': 'Structural imaging by T1-weighted MRI to measure brain volume'}, {'measure': 'Change in Cerebral Blood Flow', 'timeFrame': '28±2 days', 'description': 'change in cerebral blood flow measured by arterial spin labeling (ASL) and calculated using a one-compartment model (average cortex)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Frontal Lobe Hypometabolism']}, 'descriptionModule': {'briefSummary': 'BEAT7-001 is a single group study (supplementation). Using a multi-modal brain imaging portfolio, this study will assess whether brain energy metabolism (glucose and ketones), structure or functional connectivity change in older people with frontal glucose hypometabolism after 28 days on an oral dose of 1 g/kg/day of triheptanoin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women ≥65 years old;\n* Score ≥26/30 on the Montreal Cognitive Assessment; -≥10% lower brain glucose uptake in the frontal cortex as determined by PET imaging.\n\nExclusion Criteria:\n\n* Score \\<26/30 on the Montreal Cognitive Assessment;\n* Medications likely to affect the primary cognitive outcome;\n* Medical or psychiatric conditions that could interfere with study participation (Peterson et al. 2005);\n* Fasting plasma glucose ≥7.0 mM (to avoid recruiting diabetics or pre-diabetics, both of which are risk factors for cognitive impairment in older persons (Mortimer et al. 2010) and also inhibit ketogenesis (Fukao et al. 2004);\n* Clinically-significant gastro-intestinal disease/conditions;\n* Clinically-significant liver disease/dysfunction : ALT ≥37 UI/L, AST ≥36 UI/L, Total bilirubin ≥26 μmol/L;\n* Clinically-significant renal disease/dysfunction : creatinine ≥92 μmol/L, glomerular filtration rate \\<60 ml/min/1.73 m2 or \\>90 ml/min/1.73 m2;\n* Clinically-significant cardiac disease/conditions;\n* Clinically-significant abnormal coagulation laboratory results or coagulation disorders at screening;\n* Poorly controlled dyslipidemia (total cholesterol ≥6.2 mmol/L or triglycerides ≥2.20 mmol/L)\n* Hypertension: ≥140/90 mmHg;\n* Substance abuse;\n* Already on MCT supplementation;\n* Visual or hearing impairment impeding comprehension;\n* Non-French speaking;\n* Any condition with life expectancy less than 5 years;\n* Institutionalized or intending to move out of area within 1 year;\n* Participation in other intervention trials.'}, 'identificationModule': {'nctId': 'NCT02679235', 'acronym': 'BEAT7', 'briefTitle': 'Brain Energy and Aging With Triheptanoin', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'Brain Energy and Aging With Triheptanoin: The BEAT7 Study', 'orgStudyIdInfo': {'id': '2016-617'}, 'secondaryIdInfos': [{'id': '188505', 'type': 'REGISTRY', 'domain': 'Office of Clinical Trials - Health Canada'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Triheptanoin', 'description': 'Participant will undergo POST Triheptanoin suppementation 1g/kg body weight for 28 days (dose gradually increased each week, starting at, 0.25, 0.5, 0.75 and then 1 g) separated in 4 doses (with eah meal and before night) after a control PRE supplementation imaging protocol.', 'interventionNames': ['Drug: POST Triheptanoin']}], 'interventions': [{'name': 'POST Triheptanoin', 'type': 'DRUG', 'otherNames': ['POST THN'], 'description': 'The target daily dose of triheptanoin will be 1 g/kg/d, or approximately 70 g/d during 28±2 days. It will be divided into four daily doses, one of which will be consumed at each meal and one with an evening snack.', 'armGroupLabels': ['Triheptanoin']}]}, '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, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ultragenyx Pharmaceutical Inc', 'class': 'INDUSTRY'}, {'name': 'Fonds de la Recherche en Santé du Québec', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}