Ignite Creation Date:
2025-12-24 @ 5:47 PM
Ignite Modification Date:
2025-12-25 @ 3:14 PM
Study NCT ID:
NCT03461068
Status:
COMPLETED
Last Update Posted:
2019-04-18
First Post:
2018-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exogenous Ketones and Glucose Tolerance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Placebo masked with flavouring and participants consume in opaque containers'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-17', 'studyFirstSubmitDate': '2018-03-04', 'studyFirstSubmitQcDate': '2018-03-08', 'lastUpdatePostDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucose area under the curve', 'timeFrame': '2-hour', 'description': 'Area under the curve for glucose during oral glucose tolerance test'}], 'secondaryOutcomes': [{'measure': 'Insulin area under the curve', 'timeFrame': '2-hour', 'description': 'Insulin area under the curve during oral glucose tolerance test'}, {'measure': 'Free fatty acids area under the curve', 'timeFrame': '2-hour', 'description': 'Non-esterified fatty acids area under the curve during oral glucose tolerance test'}, {'measure': 'Caspase-1 activation', 'timeFrame': '15 minutes', 'description': 'Caspase-1 activation assessed before and after ketone or placebo ingestion in the morning'}, {'measure': 'Inflammatory cytokines', 'timeFrame': '15 minutes', 'description': 'Inflammatory cytokines assessed before and after ketone or placebo ingestion in the morning'}, {'measure': 'C-peptide area under the curve', 'timeFrame': '2-hour', 'description': 'C-peptide area under the curve during oral glucose tolerance test'}, {'measure': 'GLP-1 area under the curve', 'timeFrame': '2-hour', 'description': 'GLP-1 area under the curve during oral glucose tolerance test'}, {'measure': 'Glucagon area under the curve', 'timeFrame': '2-hour', 'description': 'Glucagon area under the curve during oral glucose tolerance test'}, {'measure': 'Glucose incremental area under the curve', 'timeFrame': '2-hour', 'description': 'Incremental area under the curve (above baseline) for glucose during oral glucose tolerance test'}, {'measure': 'Insulin incremental area under the curve', 'timeFrame': '2-hour', 'description': 'Incremental area under the curve (above baseline) for insulin during oral glucose tolerance test'}, {'measure': '2-hr glucose level', 'timeFrame': '2-hour', 'description': 'Plasma glucose assessed 2-hr after oral glucose tolerance test.'}, {'measure': 'Oral glucose sensitivity index', 'timeFrame': '2-hour', 'description': 'Oral glucose sensitivity index derived from glucose and insulin values throughout the 2-hr oral glucose tolerance test'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ketones', 'Dietary Supplements']}, 'referencesModule': {'references': [{'pmid': '31599919', 'type': 'DERIVED', 'citation': 'Myette-Cote E, Caldwell HG, Ainslie PN, Clarke K, Little JP. A ketone monoester drink reduces the glycemic response to an oral glucose challenge in individuals with obesity: a randomized trial. Am J Clin Nutr. 2019 Dec 1;110(6):1491-1501. doi: 10.1093/ajcn/nqz232.'}]}, 'descriptionModule': {'briefSummary': 'The ketone body beta-hydroxybutyrate is produced during prolonged fasting or when endogenous carbohydrate stores are depleted and can be used as an alternative fuel source. Exogenous beta-hydroxybutyrate, in the form of a ketone monoester, is proposed to have glucose-lowering potential but this has not been adequately studied. The purpose of this study is to determine whether supplementing with an acute dose of ketone monoester can improve the glycemic response to an oral glucose tolerance test in individuals with impaired fasting glucose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Not taking any medications affecting glucose metabolism.\n* Elevated fasting glucose level (5.6-6.9 mmol/L) OR body mass index \\>28 kg/m2 OR elevated waist circumference (\\>102 cm for males, \\>88 cm for females)\n\nExclusion Criteria:\n\n* Diagnosed with diabetes.\n* Diagnosed with heart disease.\n* Competitive endurance athlete (self-identified as engaged in specific endurance training in triathlon, cycling, or distance running and competing in races or competition)\n* Recent (last 3 months) or current consumption of a low-carbohydrate ketogenic diet\n* Current consumption of ketone supplements\n* Pregnant or planning to become pregnant during the study (if female)'}, 'identificationModule': {'nctId': 'NCT03461068', 'briefTitle': 'Exogenous Ketones and Glucose Tolerance', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'The Effect of Exogenous Ketone Monoester Supplement on Glycemic Response to an Oral Glucose Tolerance Test', 'orgStudyIdInfo': {'id': 'H16-01846'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ketone monoester', 'description': 'Acute morning dose of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (0.45 ml/kg body weight)', 'interventionNames': ['Dietary Supplement: Ketone monoester']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Acute morning dose of flavour-matched placebo.', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Ketone monoester', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior a 2-hour oral glucose tolerance test.', 'armGroupLabels': ['Ketone monoester']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Acute ingestion of a taste-matched placebo prior a 2-hour oral glucose tolerance test.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V1V 1V7', 'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'University of British Columbia, Okanagan.', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jonathan Little', 'investigatorAffiliation': 'University of British Columbia'}}}}