Clinical Trials Directory

Trials / Completed

CompletedNCT07065864

Ketone Esters for Optimization of Operator Performance in Hypoxia

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
17 (actual)
Sponsor
Florida Institute for Human and Machine Cognition · Academic / Other
Sex
Male
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTKetone esterStandardized 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).
OTHERPlacebosteady 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

Timeline

Start date
2023-08-04
Primary completion
2023-09-01
Completion
2023-11-14
First posted
2025-07-15
Last updated
2025-07-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT07065864. Inclusion in this directory is not an endorsement.