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| ID | Type | Description | Link |
|---|---|---|---|
| H9240519C0016 | Other Identifier | U.S. Special Operations Command |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketone | Experimental | Ketone consumption prior to 24 minute submaximal bicycle ride at simulated 4500 meter altitude. |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate physiologic reserve in hypoxia | Evaluate submaximal steady state heart rate (HR) exercise variables ( ↑HR that is affiliated with hypoxia). | 6.5 hours time commitment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Institute for Human and Machine Cognition | Pensacola | Florida | 32502 | United States |
All data will be immediately de-identified and shared with participants.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 18, 2023 | Jun 17, 2025 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C524675 | formic acid 4-(3-oxobutyl)phenyl ester |
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Participants will be randomized to one of two interventions per visit: placebo and ketone
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Participants are blinded to ketone or placebo consumption.
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| 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 |
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