Ketone Esters for Optimization of Cognitive Performance in Hypoxia
NCT ID: NCT03659825
Last Updated: 2018-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
16 participants
INTERVENTIONAL
2018-09-01
2018-11-15
Brief Summary
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Detailed Description
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HVMN, in collaboration with researchers at IHMC, proposes a study to investigate the effects of consuming an FDA-approved ketone ester 'food' on cognitive performance in the setting of hypoxia. For the proposed 4-arm within-subject study, participants will complete a cognitive performance test battery under the conditions of normoxia and then hypoxia following consumption of a ketone ester drink or a placebo drink (N.B for each study drink cognitive performance in both hypoxia and normoxia will be assessed in ONE visit):
VISIT A:
Arm1: Normoxia + Placebo Arm 2: Hypoxia + Placebo
VISIT B:
Arm 3: Normoxia + Ketone ester Arm 4: Hypoxia + Ketone ester
The investigators hypothesize that ketone ester supplementation will attenuate hypoxia-induced deterioration of operator cognitive performance.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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Placebo + Normoxia
Taste, volume and appearance matched drink given before cognitive testing in normoxia
Taste Matched Placebo
Placebo that tastes similar to active intervention
Placebo + Hypoxia
Taste, volume and appearance matched drink given before cognitive testing in hypoxia
Taste Matched Placebo
Placebo that tastes similar to active intervention
Hypoxic exposure
Participants will breath through a mask to provide the amount of oxygen typically seen at 16-17,000ft of altitude.
Ketone Ester + Normoxia
Ketone ester drink given before cognitive testing in normoxia
Ketone Ester
Flavored sports drink containing deltaG (betahydroxybutyrate monoester) as the sole active ingredient, diluted with water.
Ketone Ester + Hypoxia
Ketone ester drink given before cognitive testing in hypoxia
Ketone Ester
Flavored sports drink containing deltaG (betahydroxybutyrate monoester) as the sole active ingredient, diluted with water.
Hypoxic exposure
Participants will breath through a mask to provide the amount of oxygen typically seen at 16-17,000ft of altitude.
Interventions
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Ketone Ester
Flavored sports drink containing deltaG (betahydroxybutyrate monoester) as the sole active ingredient, diluted with water.
Taste Matched Placebo
Placebo that tastes similar to active intervention
Hypoxic exposure
Participants will breath through a mask to provide the amount of oxygen typically seen at 16-17,000ft of altitude.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
45 Years
MALE
Yes
Sponsors
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Florida Institute for Human and Machine Cognition
OTHER
HVMN Inc
INDUSTRY
Responsible Party
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References
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Stubbs BJ, Cox PJ, Evans RD, Santer P, Miller JJ, Faull OK, Magor-Elliott S, Hiyama S, Stirling M, Clarke K. On the Metabolism of Exogenous Ketones in Humans. Front Physiol. 2017 Oct 30;8:848. doi: 10.3389/fphys.2017.00848. eCollection 2017.
Suzuki M, Suzuki M, Sato K, Dohi S, Sato T, Matsuura A, Hiraide A. Effect of beta-hydroxybutyrate, a cerebral function improving agent, on cerebral hypoxia, anoxia and ischemia in mice and rats. Jpn J Pharmacol. 2001 Oct;87(2):143-50. doi: 10.1254/jjp.87.143.
Kirsch JR, D'Alecy LG, Mongroo PB. Butanediol induced ketosis increases tolerance to hypoxia in the mouse. Stroke. 1980 Sep-Oct;11(5):506-13. doi: 10.1161/01.str.11.5.506.
Xu K, Sun X, Eroku BO, Tsipis CP, Puchowicz MA, LaManna JC. Diet-induced ketosis improves cognitive performance in aged rats. Adv Exp Med Biol. 2010;662:71-5. doi: 10.1007/978-1-4419-1241-1_9.
Related Links
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HVMN product website
Other Identifiers
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KEHYPOX18
Identifier Type: -
Identifier Source: org_study_id
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