protocolSection identificationModule nctId: NCT06320522, orgStudyIdInfo id: R82053/RE002, briefTitle: Exogenous Ketosis in a Fed and a Fasted State, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-02-15, primaryCompletionDateStruct date: 2024-05, completionDateStruct date: 2024-05, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: University of Oxford, class: OTHER, descriptionModule briefSummary: The kinetics of circulating βHB following ingestion of the ketone monoester are dependent on several variables that determine the balance between appearance into, and disappearance from, the bloodstream. These dynamics have been well characterised in fasted humans but in the real world the ketone monoester is likely to be ingested in a fed state, pertinently within athletic spheres consumption would proceed a substantial high-carbohydrate meal. Within this, it is unclear how metabolism under exogenous ketosis might be affected in a fed versus fasted state.This four-arm crossover study looks to characterise the relationship between feeding status, βHB pharmacokinetics, and resting metabolism.As exogenous ketosis is known to reduce circulating glucose levels, this study will also explored if hepatic metabolism - for example, de novo lipogenesis - might consequently be altered, with implications for metabolic disease states such as Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and type II diabetes.Participants will be asked to consume either the ketone monoester drink or a placebo drink when fasted and when having previously consumed a meal., conditionsModule conditions: Ketosis, conditions: Exogenous Ketosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Ketone Monoester, interventions name: Placebo, outcomesModule primaryOutcomes measure: Plasma β-hydroxybutyrate (βHB) kinetics, primaryOutcomes measure: Plasma glucose kinetics, primaryOutcomes measure: Postprandial de novo lipogenesis (DNL), secondaryOutcomes measure: Plasma biochemistry, secondaryOutcomes measure: Very low-density lipoprotein-triglyceride (VLDL-TG) fatty acid composition, secondaryOutcomes measure: Breath acetone, secondaryOutcomes measure: Urine volume, secondaryOutcomes measure: Urine composition, secondaryOutcomes measure: Indirect calorimetry, secondaryOutcomes measure: Subjective measures of appetite, secondaryOutcomes measure: Subjective measures of gastrointestinal distress, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Oxford Centre for Diabetes, Endocrinology, and Metabolism (OCDEM), status: RECRUITING, city: Oxford, state: Oxfordshire, zip: OX3 7LE, country: United Kingdom, contacts name: Leanne Hodson, PhD, role: CONTACT, phone: 01865 857224, email: leanne.hodson@ocdem.ox.ac.uk, contacts name: Leanne Hodson, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Adam Isherwood, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 51.75222, lon: -1.25596, hasResults: False