Ketone Esters for Optimization of Cognitive Performance in Hypoxia

Ketone Esters for Optimization of Cognitive Performance in Hypoxia

Sponsors

Lead sponsor: HVMN Inc

Collaborator: Institute for Human and Machine Cognition

Source HVMN Inc
Brief Summary

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

Detailed 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.

Overall Status Not yet recruiting
Start Date September 1, 2018
Completion Date November 15, 2018
Primary Completion Date October 31, 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Cognitive Performance- Visual Acuity 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.
Change in Cognitive Performance- Contrast Sensitivity 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.
Change in Cognitive Performance- Choice Reaction Time 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.
Change in Cognitive Performance- Eye Tracking- Smooth Pursuit 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.
Change in Cognitive Performance- Eye Tracking- Saccades 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.
Change in Cognitive Performance- Simple Reaction Time 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 Outcome
Measure Time Frame
Change in Grip Strength 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.
Change in blood ketone levels Measured 5 times at regular intervals through each of the two study visits. [time (min) = 0, 30, 75, 105, 150]
Change in blood glucose levels Measured 5 times at regular intervals through each of the two study visits. [time (min) = 0, 30, 75, 105, 150]
Enrollment 16
Condition
Intervention

Intervention type: Dietary Supplement

Intervention name: Ketone Ester

Description: Flavored sports drink containing deltaG (betahydroxybutyrate monoester) as the sole active ingredient, diluted with water.

Other name: HVMN Ketone

Intervention type: Dietary Supplement

Intervention name: Taste Matched Placebo

Description: Placebo that tastes similar to active intervention

Intervention type: Other

Intervention name: Hypoxic exposure

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

Eligibility

Criteria:

Inclusion Criteria:

* Pass medical examination on enrollment.

Exclusion Criteria:

* Active smoker, substance abuse.

Gender: Male

Minimum age: 18 Years

Maximum age: 45 Years

Healthy volunteers: Accepts Healthy Volunteers

Verification Date

August 2018

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Arm group label: Placebo + Normoxia

Arm group type: Placebo Comparator

Description: Taste, volume and appearance matched drink given before cognitive testing in normoxia

Arm group label: Placebo + Hypoxia

Arm group type: Placebo Comparator

Description: Taste, volume and appearance matched drink given before cognitive testing in hypoxia

Arm group label: Ketone Ester + Normoxia

Arm group type: Experimental

Description: Ketone ester drink given before cognitive testing in normoxia

Arm group label: Ketone Ester + Hypoxia

Arm group type: Experimental

Description: Ketone ester drink given before cognitive testing in hypoxia

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Intervention model description: Young healthy adults.

Primary purpose: Basic Science

Masking: Double (Participant, Investigator)

Masking description: Study drinks will be matched for taste and appearance. Investigator preparing and administering the drink will not carry out the testing.

Source: ClinicalTrials.gov