Trial | NCT03659825  Report issue

Official Title

Ketone Esters for Optimization of Cognitive Performance in Hypoxia

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    Ketone Ester ...

  • Study Participants

    16
This study will investigate the effects of ketone ester drinks on cognitive performance in hypoxia.
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.
Study Started
Sep 01
2018
Anticipated
Primary Completion
Oct 31
2018
Anticipated
Study Completion
Nov 15
2018
Anticipated
Last Update
Sep 06
2018

Dietary Supplement Taste Matched Placebo

Placebo that tastes similar to active intervention

Dietary Supplement Ketone Ester

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

  • Other names: 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.

Placebo + Normoxia Placebo Comparator

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

Placebo + Hypoxia Placebo Comparator

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

Ketone Ester + Normoxia Experimental

Ketone ester drink given before cognitive testing in normoxia

Ketone Ester + Hypoxia Experimental

Ketone ester drink given before cognitive testing in hypoxia

Criteria 

Inclusion Criteria:

* Pass medical examination on enrollment.

Exclusion Criteria:

* Active smoker, substance abuse.
No Results Posted