Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2025-12-31 @ 7:06 PM
Study NCT ID:
NCT06746805
Status:
RECRUITING
Last Update Posted:
2025-09-24
First Post:
2024-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Acute Ketone Monoester Supplementation on Glucose Oxidation During Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Color and flavor matched placebo'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Double-blind, randomized, placebo-controlled, cross-over trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 27}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-19', 'studyFirstSubmitDate': '2024-03-11', 'studyFirstSubmitQcDate': '2024-12-18', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Total carbohydrate oxidation', 'timeFrame': 'Acute:during 3 hours of exercise', 'description': 'Total carbohydrate oxidation during exercise, measured indirectly by using traditional stoichiometric calculations of carbohydrate oxidation. CHO+KETONE vs CHO+PLACEBO condition'}, {'measure': 'Blood parameters', 'timeFrame': 'Acute:during 3 hours of exercise', 'description': 'Plasma glucose, insulin, glycerol, free fatty acids, and ketone body concentrations (including area under the curve) following drink ingestion. CHO+KETONE vs CHO+PLACEBO condition'}, {'measure': 'Exercise economy during cycling', 'timeFrame': 'Acute:during 3 hours of exercise', 'description': 'Exercise economy during the exercise trial. CHO+KETONE vs CHO+PLACEBO condition, will be determined based on the amount of work performed during cycling (workload), and the amount of energy expenditure as measured by indirect calorimetry.'}, {'measure': 'Exercise heart rate', 'timeFrame': 'Acute:during 3 hours of exercise', 'description': 'Heart rate during exercise. CHO+KETONE vs CHO+PLACEBO condition'}], 'primaryOutcomes': [{'measure': 'Exogenous carbohydrate oxidation rate', 'timeFrame': 'Acute:during 3 hours of exercise', 'description': 'Exogenous carbohydrate oxidation rate during exercise measured by 13C enrichment in breath. CHO+KETONE vs CHO+PLACEBO condition'}], 'secondaryOutcomes': [{'measure': 'Endogenous carbohydrate disappearance rate', 'timeFrame': 'Acute:during 3 hours of exercise', 'description': 'Endogenous carbohydrate disappearance rate during exercise measured by stable isotope tracer methodology. CHO+KETONE vs CHO+PLACEBO condition'}, {'measure': 'Exogenous carbohydrate disappearance rate', 'timeFrame': 'Acute:during 3 hours of exercise', 'description': 'Exogenous carbohydrate disappearance rate during exercise measured by stable isotope tracer methodology. CHO+KETONE vs CHO+PLACEBO condition'}, {'measure': 'Total carbohydrate disappearance rate', 'timeFrame': 'Acute:during 3 hours of exercise', 'description': 'Total carbohydrate disappearance rate during exercise measured by stable isotope tracer methodology. CHO+KETONE vs CHO+PLACEBO condition'}, {'measure': 'Exogenous carbohydrate appearance rate', 'timeFrame': 'Acute:during 3 hours of exercise', 'description': 'Exogenous carbohydrate appearance rate during exercise measured by stable isotope tracer methodology. CHO+KETONE vs CHO+PLACEBO condition'}, {'measure': 'Endogenous carbohydrate appearance rate', 'timeFrame': 'Acute:during 3 hours of exercise', 'description': 'Endogenous carbohydrate appearance rate during exercise measured by stable isotope tracer methodology. CHO+KETONE vs CHO+PLACEBO condition'}, {'measure': 'Total carbohydrate appearance rate', 'timeFrame': 'Acute:during 3 hours of exercise', 'description': 'Total carbohydrate appearance rate during exercise measured by stable isotope tracer methodology. CHO+KETONE vs CHO+PLACEBO condition'}, {'measure': 'Plasma glucose enrichments during exercise', 'timeFrame': 'Acute:during 3 hours of exercise', 'description': 'Plasma glucose enrichments during exercise measured by stable isotope tracer methodology. CHO+KETONE vs CHO+PLACEBO condition'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Exercise Metabolism']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effect of exogenous ketone body supplementation on carbohydrate metabolism during exercise. In a randomized, crossover, and double-blind study, 20 endurance trained adult males and females aged 18-50 years, will ingest carbohydrates with either a ketone monoester supplement before and throughout a 3-hour exercise session or carbohydrates with a flavour-matched ketone-free placebo. The main aim of this study is to compare the exogenous carbohydrate oxidation rates during exercise between the ketone monoester and placebo conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18-50 years of age\n* Trained cyclist/triathlete (VO2peak \\> 55 ml/kg/min for males and \\>48 ml/mg/min for females)\n* Healthy as per medical history and investigator's/physician's judgement\n* Having given written informed consent\n\nExclusion Criteria:\n\n* Use of medication that could impact study outcomes and/or interfere with the expected mechanism of action of ketone supplements (e.g. Chronic use of gastric acid suppressing medication, statins, corticosteroids)\n* Smoking\n* Diagnosed acute or chronic medical conditions that, in the opinion of the investigator, could impact study outcomes (e.g. Diabetes mellitus)\n* Diagnosed musculoskeletal disorders\n* Adhering to a carbohydrate restrictive diet\n* Participation in another study at the same time\n* Blood donation in the 2 months before the first experimental trial\n* Plasma donation in the 2 weeks before the first experimental trial\n* Males: VO2peak \\<55 ml/min/kg body mass\n* Females: VO2peak \\<48 ml/min/kg body mass\n* Females: pregnancy"}, 'identificationModule': {'nctId': 'NCT06746805', 'acronym': 'KETONE', 'briefTitle': 'The Effect of Acute Ketone Monoester Supplementation on Glucose Oxidation During Exercise', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'The Effect of Acute Ketone Monoester Supplementation on Glucose Oxidation During Exercise Performed With High Rates of Carbohydrate Ingestion in Trained Cyclists', 'orgStudyIdInfo': {'id': 'METC 23-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CHO+KETONE', 'description': 'Interventional drink with glucose + ketone monoester', 'interventionNames': ['Dietary Supplement: CHO+KETONE']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'CHO+PLACEBO', 'description': 'Placebo drink with glucose + placebo', 'interventionNames': ['Dietary Supplement: CHO+PLACEBO']}], 'interventions': [{'name': 'CHO+KETONE', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Sports drink containing glucose and ketone mono-esters', 'armGroupLabels': ['CHO+KETONE']}, {'name': 'CHO+PLACEBO', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Sports drink containing glucose and placebo', 'armGroupLabels': ['CHO+PLACEBO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6229ER', 'city': 'Maastricht', 'state': 'Limburg', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'LJC van Loon, Professor', 'role': 'CONTACT', 'email': 'L.vanLoon@maastrichtuniversity.nl', 'phone': '0031433881397'}, {'name': 'Philippe Pinckaers, MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Maastricht University Medical Center+', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'centralContacts': [{'name': 'Luc van Loon, PhD', 'role': 'CONTACT', 'email': 'l.vanloon@maastrichtuniversity.nl', 'phone': '0031 43 388 1743'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data will be made available upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}