Ketone Esters for Optimization of Operator Performance in Hypoxia

Not Applicable

Completed

• Conditions: Hypoxia

• Registration Number: NCT07065864
• Lead Sponsor: Florida Institute for Human and Machine Cognition

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.

Study Timeline

• Study Start: 2023-08-04
• Primary Completion: 2023-09-01
• Study Completion: 2023-11-14
• Study First Submitted: 2025-06-10
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-11
• Last Update Submitted: 2025-07-11
• Study First Posted: 2025-07-15
• Last Update Posted: 2025-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 17

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Evaluate submaximal exercise performance	6.5 hours time commitment	Evaluate 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 Outcome Measures

Name	Time	Method
Evaluate physiologic reserve in hypoxia	6.5 hours time commitment	Evaluate submaximal steady state heart rate (HR) exercise variables ( ↑HR that is affiliated with hypoxia).

Trial Locations

Locations (1)

Florida Institute for Human and Machine Cognition; 🇺🇸 Pensacola, Florida, United States