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Completed

NCT Number: NCT07065864

Ketone Esters for Optimization of Operator Performance in Hypoxia

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.

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Key information

Conditions

Hypoxia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Florida Institute for Human and Machine Cognition

Pensacola, Florida, 32502, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Ketone ester

Dietary Supplement

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).

Placebo

Other

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

Primary outcomes

  1. Evaluate submaximal exercise performance

    Time frame: 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 outcomes

  1. Evaluate physiologic reserve in hypoxia

    Time frame: 6.5 hours time commitment

    Evaluate submaximal steady state heart rate (HR) exercise variables ( ↑HR that is affiliated with hypoxia).

Sponsors and collaborators

Lead sponsor

Florida Institute for Human and Machine Cognition

Other

Registry information

Official study title

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

Acronym: HVMN7

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 15, 2025
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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