Ketone Esters for Optimization of Operator Performance in Hypoxia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-04

Study Completion Date

2023-11-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Ketone Esters for Optimization of Cognitive Performance in Hypoxia

NCT03659825

Hypoxia Ketosis

UNKNOWN NA

The Effects of Ketone Ester Supplementation During a 5 Week Live High, Train Low Altitude Training Camp

NCT06596083

Hypoxia Exogenous Ketosis

RECRUITING NA

Effect of Ketone Ester Supplementation on Sleep and Recovery in Hypoxia

NCT06060093

Ketosis Hypoxia Sleep

COMPLETED NA

Ketone Supplements and Substrate Oxidation and Physical Performance

NCT04737694

Ketosis Glucose Metabolism

UNKNOWN NA

Acute Effects of Exercise Combined With Ketone Ester Supplement

NCT06365957

Overweight and Obesity Cognitive Change Ketoses, Metabolic

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Hypoxia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Participants are blinded to ketone or placebo consumption.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ketone

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

Group Type EXPERIMENTAL

Ketone ester

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ketone ester

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).

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes