Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT07063732
Status:
RECRUITING
Last Update Posted:
2025-07-14
First Post:
2025-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ketone Monoester Supplements, High Altitude, and Brain Blood Flow During Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2025-05-28', 'studyFirstSubmitQcDate': '2025-07-02', 'lastUpdatePostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cerebral Blood Velocity', 'timeFrame': '3 hours', 'description': 'Transcranial Doppler ultrasound will be used to measure blood velocity in the middle cerebral artery and posterior cerebral artery. Location of measurements will remain consistent within participants.'}], 'secondaryOutcomes': [{'measure': 'Cardiac Output', 'timeFrame': '3 hours', 'description': 'Cardiac output (L/min) will be measured using a non-invasive cardiac output monitor (Physioflow). The monitor uses signal morphology impedance cardiography to determine cardiac output.'}, {'measure': 'Blood Pressure', 'timeFrame': '3 hours', 'description': 'Mean arterial pressure (mmHg) will be measured via a brachial cuff placed on the upper arm.'}, {'measure': 'Ventilatory Threshold', 'timeFrame': '3 hours', 'description': 'Ventilatory threshold (VT) will be calculated based on previously described methods (Gaskill et al., 2001).'}, {'measure': 'End-Tidal Gases', 'timeFrame': '3 hours', 'description': 'End-tidal oxygen (PETO2) (mmHg) and carbon dioxide (PETCO2) (mmHg) will be collected using a metabolic cart.'}, {'measure': 'Rate of Oxygen Consumption and Carbon Dioxide Production', 'timeFrame': '3 hours', 'description': 'Rate of oxygen consumption (VO2) (mL/min) and carbon dioxide production (VCO2) (mL/min) will be collected using a metabolic cart.'}, {'measure': 'Ventilation', 'timeFrame': '3 hours', 'description': 'Ventilation (Ve) (L/min) will be collected using a metabolic cart.'}, {'measure': 'Blood Lactate and Beta-Hydroxybutyrate', 'timeFrame': '3 hours', 'description': 'Capillary blood will be obtained via finger prick using a lancing device to measure concentrations of blood lactate (mmol/L) and beta-hydroxybutyrate (mmol/L) using a handheld metabolite analyzer.'}, {'measure': 'Peak Work Rate (Maximal Exercise Test)', 'timeFrame': '3 hours', 'description': 'The maximum wattage (W) achieved by the participant during the maximal exercise test will be recorded.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['High Altitude Hypoxia', 'Exercise']}, 'referencesModule': {'references': [{'pmid': '11689733', 'type': 'BACKGROUND', 'citation': 'Gaskill SE, Ruby BC, Walker AJ, Sanchez OA, Serfass RC, Leon AS. Validity and reliability of combining three methods to determine ventilatory threshold. Med Sci Sports Exerc. 2001 Nov;33(11):1841-8. doi: 10.1097/00005768-200111000-00007.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to investigate the effect of acute ketone monoester ingestion (0.6 g KME/kg body weight) on the occurrence of the ventilatory threshold and the subsequent response of blood velocity in cerebral arteries during a maximal exercise test at low altitude and high altitude.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Must be a member of the research expedition team travelling to the Barcroft Research Station in White Mountain California\n\nExclusion Criteria:\n\n* BMI \\> 30\n* No prescribed medications (oral contraceptives excluded)\n* History of smoking\n* Currently following a ketogenic diet or consuming exogenous ketogenic supplements\n* History of heart, lung, blood vessel, or kidney disease\n* Currently pregnant'}, 'identificationModule': {'nctId': 'NCT07063732', 'briefTitle': 'Ketone Monoester Supplements, High Altitude, and Brain Blood Flow During Exercise', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'The Effect of Ketone Monoester Supplementation and High Altitude on Exercising Cerebral Blood Flow', 'orgStudyIdInfo': {'id': 'KETEX_WM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Altitude (3800m; Barcroft Research Station)', 'description': 'High altitude setting', 'interventionNames': ['Dietary Supplement: Ketone Monoester (KME)', 'Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Low Altitude (334m; University of Guelph)', 'description': 'Low altitude setting', 'interventionNames': ['Dietary Supplement: Ketone Monoester (KME)', 'Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Ketone Monoester (KME)', 'type': 'DIETARY_SUPPLEMENT', 'description': '0.6 g KME per kg body mass; \\[R\\]-3-hydroxybutyl \\[R\\]-3-hydroxybutyrate. (Delta G Ketone, TΔS, Oxford).', 'armGroupLabels': ['High Altitude (3800m; Barcroft Research Station)', 'Low Altitude (334m; University of Guelph)']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Inert, calorie-free placebo drink that is taste-matched to the ketone monoester supplement', 'armGroupLabels': ['High Altitude (3800m; Barcroft Research Station)', 'Low Altitude (334m; University of Guelph)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93514', 'city': 'Bishop', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeremy Walsh, PhD', 'role': 'CONTACT', 'email': 'walshj18@mcmaster.ca', 'phone': '9055259140'}], 'facility': 'Barcroft Research Station', 'geoPoint': {'lat': 37.36354, 'lon': -118.39511}}, {'zip': 'N1G 2W1', 'city': 'Guelph', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Jeremy Walsh, PhD', 'role': 'CONTACT', 'email': 'walshj18@mcmaster.ca', 'phone': '9055259140'}], 'facility': 'University of Guelph', 'geoPoint': {'lat': 43.54594, 'lon': -80.25599}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jeremy Walsh', 'investigatorAffiliation': 'McMaster University'}}}}