Ketone Esters for Optimization of Cognitive Performance in Hypoxia

HVMN Inc

Status: Unknown

Conditions: Ketosis; Hypoxia

Treatments: Dietary Supplement: Taste Matched Placebo; Other: Hypoxic exposure; Dietary Supplement: Ketone Ester

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03659825

KEHYPOX18

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

* Pass medical examination on enrollment.

Exclusion criteria

* Active smoker, substance abuse.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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16 participants in 4 patient groups, including a placebo group

Placebo + Normoxia

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Taste Matched Placebo

Placebo + Hypoxia

Placebo Comparator group

Description:

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

Treatment:

Other: Hypoxic exposure

Dietary Supplement: Taste Matched Placebo

Ketone Ester + Normoxia

Experimental group

Description:

Ketone ester drink given before cognitive testing in normoxia

Treatment:

Dietary Supplement: Ketone Ester

Ketone Ester + Hypoxia

Experimental group

Description:

Ketone ester drink given before cognitive testing in hypoxia

Treatment:

Dietary Supplement: Ketone Ester

Other: Hypoxic exposure