Ketone Esters for Optimization of Operator Performance in Hypoxia

NCT07065864 | Completed

• 2 other identifiers: IRB-2021-0029H9240519C0016
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxia

Keywords

Hypoxia

Outcome Measures

Primary Outcomes (1)

• Evaluate submaximal exercise performance

  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.

  6.5 hours time commitment

Secondary Outcomes (1)

• Evaluate physiologic reserve in hypoxia

  6.5 hours time commitment

Study Arms (2)

Ketone

EXPERIMENTAL

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

Dietary Supplement: Ketone ester

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

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).

Ketone

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Florida Institute for Human and Machine Cognition: lead

Study Sites (1)

Florida Institute for Human and Machine Cognition

Pensacola, Florida, 32502, United States

Location

MeSH Terms

Conditions

Hypoxia

Interventions

formic acid 4-(3-oxobutyl)phenyl ester

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are blinded to ketone or placebo consumption.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: July 15, 2025
• Study Start: August 4, 2023
• Primary Completion: September 1, 2023
• Study Completion: November 14, 2023
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)