An interventional study of Ketone Monoester (KME) and Placebo in High Altitude Hypoxia and Exercise, sponsored by McMaster University. Recruiting at 2 sites in 2 countries. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-14.
Sponsored by McMaster University · Not applicable, Interventional, and Basic science
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.
2,431 studies on the registry are indexed under Motor Activity; 1,162 are open to participants now.
This study's planned enrollment of 14 is below the median of 60 across 2,123 interventional studies indexed under Motor Activity.
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Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
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- Must be a member of the research expedition team travelling to the Barcroft Research Station in White Mountain California
Exclusion Criteria:
High altitude setting
Dietary Supplement: Ketone Monoester (KME) · Dietary Supplement: Placebo
Low altitude setting
Dietary Supplement: Ketone Monoester (KME) · Dietary Supplement: Placebo
0.6 g KME per kg body mass; \[R\]-3-hydroxybutyl \[R\]-3-hydroxybutyrate. (Delta G Ketone, TΔS, Oxford).
Inert, calorie-free placebo drink that is taste-matched to the ketone monoester supplement
Cerebral Blood Velocity
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.
Time frame: 3 hours
Cardiac Output
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.
Time frame: 3 hours
Blood Pressure
Mean arterial pressure (mmHg) will be measured via a brachial cuff placed on the upper arm.
Time frame: 3 hours
Ventilatory Threshold
Ventilatory threshold (VT) will be calculated based on previously described methods (Gaskill et al., 2001).
Time frame: 3 hours
End-Tidal Gases
End-tidal oxygen (PETO2) (mmHg) and carbon dioxide (PETCO2) (mmHg) will be collected using a metabolic cart.
Time frame: 3 hours
Rate of Oxygen Consumption and Carbon Dioxide Production
Rate of oxygen consumption (VO2) (mL/min) and carbon dioxide production (VCO2) (mL/min) will be collected using a metabolic cart.
Time frame: 3 hours
Ventilation
Ventilation (Ve) (L/min) will be collected using a metabolic cart.
Time frame: 3 hours
Blood Lactate and Beta-Hydroxybutyrate
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.
Time frame: 3 hours
Peak Work Rate (Maximal Exercise Test)
The maximum wattage (W) achieved by the participant during the maximal exercise test will be recorded.
Time frame: 3 hours
Plan to share: Undecided
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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