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Ketone Esters for Optimization of Operator Performance in Hypoxia

Ketone Body Administration Impact on Work Capacity and Physiologic Reserve at Altitude

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07065864
Acronym
HVMN7
Enrollment
17
Registered
2025-07-15
Start date
2023-08-04
Completion date
2023-11-14
Last updated
2025-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxia

Keywords

Hypoxia

Brief summary

The primary purpose of the study was to investigate effects of an orally administered ketone ester drink on endurance exercise performance during acute extreme hypoxia. Drinking this ketone supplement increases energy substrates known as ketone bodies in the blood, which may also act as metabolic signaling molecules. The ketone drink used in this study is recognized by the FDA as generally regarded as safe (GRAS). Some reports suggest that high ketone levels may enhance one's ability to tolerate hypoxia.

Detailed description

High altitude environments limit oxygen availability in circulation and working tissues, leading to a decreased physiological reserve during physical exertion. Acute hypoxia elevates heart rate during submaximal work in a compensatory attempt, but decreases maximal heart rate progressively with increasing hypoxia. This contributes to a reduction in aerobic power (i.e. maximal rate of oxygen uptake, VO2max) an average of 6.3% per 1000m of elevation. Consumption of exogenous ketone bodies has been shown to enhance oxygen availability at rest at simulated altitudes up to 6100m, associated with better cognitive performance.

Interventions

DIETARY_SUPPLEMENTKetone ester

Standardized light meal, questionnaires, blood measurements (finger stick), resting physiology and steady state submaximal exercise (6 minutes each at 40, 50, and 60% of the peak power achieved at VO2max) at simulated 4500m after consuming the ketone ester or placebo (in randomized order).

OTHERPlacebo

steady state submaximal exercise (6 minutes each at 40, 50, and 60% of the peak power achieved at VO2max) at simulated 4500m after consuming the ketone ester or placebo

Sponsors

Florida Institute for Human and Machine Cognition
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Masking description

Participants are blinded to ketone or placebo consumption.

Intervention model description

Participants will be randomized to one of two interventions per visit: placebo and ketone

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Healthy adult males 18 years of age or older (females are excluded because the 7th SFG consists only of males) * Able to provide informed consent * Able to perform the prescribed exercise and all study assessments * Proficiency with the English language (reading, writing, speaking)

Exclusion criteria

* Any health or medical condition (e.g., cardiovascular, respiratory, musculoskeletal, neurologic) that would preclude exercise testing or potentially influence exercise performance, as determined by health and medical history questionnaire. * Any condition that would preclude an accurate DXA body composition scan (e.g. joint replacement).

Design outcomes

Primary

MeasureTime frameDescription
Evaluate submaximal exercise performance6.5 hours time commitmentEvaluate submaximal exercise performance and physiologic reserve in hypoxia after consuming the ketone ester or placebo drink. Submaximal steady state VO2 relative to VO2max is the primary dependent variable. High altitude environments limit oxygen availability in circulation and working tissues, leading to a decreased physiological reserve during physical exertion. This contributes to a reduction in aerobic power (i.e. maximal rate of oxygen uptake, VO2max) an average of 6.3% per 1000m of elevation. Consumption of exogenous ketone bodies has been shown to enhance oxygen availability at rest at simulated altitudes up to 6100m, associated with better cognitive performance.

Secondary

MeasureTime frameDescription
Evaluate physiologic reserve in hypoxia6.5 hours time commitmentEvaluate submaximal steady state heart rate (HR) exercise variables ( ↑HR that is affiliated with hypoxia).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026