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Ketone Esters for Optimization of Cognitive Performance in Hypoxia

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ClinicalTrials.gov Identifier: NCT03659825
Recruitment Status : Not yet recruiting
First Posted : September 6, 2018
Last Update Posted : September 6, 2018
Sponsor:
Collaborator:
Institute for Human and Machine Cognition
Information provided by (Responsible Party):
HVMN Inc

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

Condition or disease Intervention/treatment Phase
Hypoxia Ketosis Dietary Supplement: Ketone Ester Dietary Supplement: Taste Matched Placebo Other: Hypoxic exposure Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Young healthy adults.
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.
Primary Purpose: Basic Science
Official Title: Ketone Esters for Optimization of Cognitive Performance in Hypoxia
Estimated Study Start Date : September 1, 2018
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : November 15, 2018

Arm Intervention/treatment
Placebo Comparator: Placebo + Normoxia
Taste, volume and appearance matched drink given before cognitive testing in normoxia
Dietary Supplement: Taste Matched Placebo
Placebo that tastes similar to active intervention

Placebo Comparator: Placebo + Hypoxia
Taste, volume and appearance matched drink given before cognitive testing in hypoxia
Dietary Supplement: 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.

Experimental: Ketone Ester + Normoxia
Ketone ester drink given before cognitive testing in normoxia
Dietary Supplement: Ketone Ester
Flavored sports drink containing deltaG (betahydroxybutyrate monoester) as the sole active ingredient, diluted with water.
Other Name: HVMN Ketone

Experimental: Ketone Ester + Hypoxia
Ketone ester drink given before cognitive testing in hypoxia
Dietary Supplement: Ketone Ester
Flavored sports drink containing deltaG (betahydroxybutyrate monoester) as the sole active ingredient, diluted with water.
Other Name: HVMN Ketone

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




Primary Outcome Measures :
  1. Change in Cognitive Performance- Visual Acuity [ Time Frame: 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. ]
    Cognitive performance (visual acuity) will be assessed using the RightEye testing system (https://www.righteye.com).

  2. Change in Cognitive Performance- Contrast Sensitivity [ Time Frame: 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. ]
    Cognitive performance (contrast sensitivity) will be assessed using the RightEye testing system (https://www.righteye.com).

  3. Change in Cognitive Performance- Choice Reaction Time [ Time Frame: 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. ]
    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).

  4. Change in Cognitive Performance- Eye Tracking- Smooth Pursuit [ Time Frame: 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. ]
    Cognitive performance (eye tracking) will be assessed by looking for smooth pursuit (horizontal and vertical) using the RightEye testing system (https://www.righteye.com).

  5. Change in Cognitive Performance- Eye Tracking- Saccades [ Time Frame: 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. ]
    Cognitive performance (eye tracking) will be assessed by looking at saccade speed (horizontal and vertical) using the RightEye testing system (https://www.righteye.com).

  6. Change in Cognitive Performance- Simple Reaction Time [ Time Frame: 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. ]
    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).


Secondary Outcome Measures :
  1. Change in Grip Strength [ Time Frame: 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. ]
    Grip strength will be measured using a

  2. Change in blood ketone levels [ Time Frame: Measured 5 times at regular intervals through each of the two study visits. [time (min) = 0, 30, 75, 105, 150] ]
    Blood ketone levels will be measured in a finger prick blood samples using a clinical grade, handheld glucose/ketone meter (Abott Diabetes Care).

  3. Change in blood glucose levels [ Time Frame: Measured 5 times at regular intervals through each of the two study visits. [time (min) = 0, 30, 75, 105, 150] ]
    Blood glucose levels will be measured in a finger prick blood samples using a clinical grade, handheld glucose/ketone meter (Abott Diabetes Care).



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

* Pass medical examination on enrollment.

Exclusion Criteria:

* Active smoker, substance abuse.


Additional Information:
Publications:
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Responsible Party: HVMN Inc
ClinicalTrials.gov Identifier: NCT03659825     History of Changes
Other Study ID Numbers: KEHYPOX18
First Posted: September 6, 2018    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hypoxia
Signs and Symptoms, Respiratory
Signs and Symptoms