Ketone Monoester Supplements, High Altitude, and Brain Blood Flow During Exercise
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ketone Monoester (KME), Placebo.
- Who it may be relevant to
- Registry conditions: High Altitude Hypoxia, Exercise. Basic parameters: 18 years — 35 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effect of Ketone Monoester Supplementation and High Altitude on Exercising Cerebral Blood Flow
Overview
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.
Interventions
- Dietary supplement Ketone Monoester (KME)
0.6 g KME per kg body mass; \[R\]-3-hydroxybutyl \[R\]-3-hydroxybutyrate. (Delta G Ketone, TΔS, Oxford). - Dietary supplement Placebo
Inert, calorie-free placebo drink that is taste-matched to the ketone monoester supplement
Primary outcome measures
- Cerebral Blood Velocity [Time frame: 3 hours]
Secondary outcome measures (8)
- Cardiac Output [Time frame: 3 hours]
- Blood Pressure [Time frame: 3 hours]
- Ventilatory Threshold [Time frame: 3 hours]
- End-Tidal Gases [Time frame: 3 hours]
- Rate of Oxygen Consumption and Carbon Dioxide Production [Time frame: 3 hours]
- Ventilation [Time frame: 3 hours]
- Blood Lactate and Beta-Hydroxybutyrate [Time frame: 3 hours]
- Peak Work Rate (Maximal Exercise Test) [Time frame: 3 hours]
Eligibility criteria
Inclusion criteria
\- Must be a member of the research expedition team travelling to the Barcroft Research Station in White Mountain California
Exclusion criteria
- BMI > 30
- No prescribed medications (oral contraceptives excluded)
- History of smoking
- Currently following a ketogenic diet or consuming exogenous ketogenic supplements
- History of heart, lung, blood vessel, or kidney disease
- Currently pregnant
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- Barcroft Research Station — Bishop
Canada · 1 center
- University of Guelph — Guelph
Publications
- 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. PMID 11689733
Identifiers
NCT: NCT07063732 · KETEX_WM