Ketone Esters for Optimization of Operator Performance in Hypoxia (HVMN7)

State University System of Florida

Status: Completed

Conditions: Hypoxia

Treatments: Dietary Supplement: Ketone ester; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07065864

IRB-2021-0029

H9240519C0016 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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17 participants in 2 patient groups, including a placebo group

Ketone

Experimental group

Description:

Ketone consumption prior to 24 minute submaximal bicycle ride at simulated 4500 meter altitude.

Treatment:

Dietary Supplement: Ketone ester

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo