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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03659825
Other study ID # KEHYPOX18
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date November 15, 2018

Study information

Verified date August 2018
Source HVMN Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will investigate the effects of ketone ester drinks on cognitive performance in hypoxia.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
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
Other:
Hypoxic exposure
Participants will breath through a mask to provide the amount of oxygen typically seen at 16-17,000ft of altitude.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
HVMN Inc Florida Institute of Human and Machine Cognition

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Cognitive Performance- Visual Acuity Cognitive performance (visual acuity) will be assessed using the RightEye testing system (https://www.righteye.com). Measured 3 times (baseline [time = 0 min], during normoxia [time = 30-60 min post study drink 1] and during hypoxia [30-60 min post study drink 2]) in each of the two test visits.
Primary Change in Cognitive Performance- Contrast Sensitivity Cognitive performance (contrast sensitivity) will be assessed using the RightEye testing system (https://www.righteye.com). Measured 3 times (baseline [time = 0 min], during normoxia [time = 30-60 min post study drink 1] and during hypoxia [30-60 min post study drink 2]) in each of the two test visits.
Primary Change in Cognitive Performance- Choice Reaction Time Cognitive performance (choice reaction time) will be assessed using both the RightEye testing system (https://www.righteye.com) and the DANA testing system (http://www.danabrainvital.com). Measured 3 times (baseline [time = 0 min], during normoxia [time = 30-60 min post study drink 1] and during hypoxia [30-60 min post study drink 2]) in each of the two test visits.
Primary Change in Cognitive Performance- Eye Tracking- Smooth Pursuit Cognitive performance (eye tracking) will be assessed by looking for smooth pursuit (horizontal and vertical) using the RightEye testing system (https://www.righteye.com). Measured 3 times (baseline [time = 0 min], during normoxia [time = 30-60 min post study drink 1] and during hypoxia [30-60 min post study drink 2]) in each of the two test visits.
Primary Change in Cognitive Performance- Eye Tracking- Saccades Cognitive performance (eye tracking) will be assessed by looking at saccade speed (horizontal and vertical) using the RightEye testing system (https://www.righteye.com). Measured 3 times (baseline [time = 0 min], during normoxia [time = 30-60 min post study drink 1] and during hypoxia [30-60 min post study drink 2]) in each of the two test visits.
Primary Change in Cognitive Performance- Simple Reaction Time Cognitive performance (simple reaction time) will be assessed using both the RightEye testing system (https://www.righteye.com) and the DANA testing system (http://www.danabrainvital.com). Measured 3 times (baseline [time = 0 min], during normoxia [time = 30-60 min post study drink 1] and during hypoxia [30-60 min post study drink 2]) in each of the two test visits.
Secondary Change in Grip Strength Grip strength will be measured using a Measured 3 times (baseline [time = 0 min], after normoxia [60 min post study drink 1] and after hypoxia [60 min post study drink 2]) in each of the two test visits.
Secondary Change in blood ketone levels Blood ketone levels will be measured in a finger prick blood samples using a clinical grade, handheld glucose/ketone meter (Abott Diabetes Care). Measured 5 times at regular intervals through each of the two study visits. [time (min) = 0, 30, 75, 105, 150]
Secondary Change in blood glucose levels Blood glucose levels will be measured in a finger prick blood samples using a clinical grade, handheld glucose/ketone meter (Abott Diabetes Care). Measured 5 times at regular intervals through each of the two study visits. [time (min) = 0, 30, 75, 105, 150]
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