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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:

In the setting of altitude-induced hypoxia, cognitive capacity degrades and can compromise both individual and team performance. This degradation is linked to falling brain energy (ATP) levels and an increased reliance on anaerobic energy production from glucose. Ketone bodies are the evolutionary alternative substrate to glucose for brain metabolic requirements; previous studies have shown that the presence of elevated ketone bodies (ketosis) maintains brain ATP levels and reduce cerebral anaerobic glycolysis during hypoxia. Ketosis can be achieved when fasting or following a ketogenic diet; however, these approaches are impractical. Exogenous ketone ester supplementation allows for rapid (< 30 mins) and significant elevation of blood ketone levels without the need to maintain a diet or fast.

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 16
Est. completion date November 15, 2018
Est. primary completion date October 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

* Pass medical examination on enrollment.

Exclusion Criteria:

* Active smoker, substance abuse.

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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