NCT03659825

Ketone Esters for Optimization of Cognitive Performance in Hypoxia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: HVMN Inc · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hypoxia
• Ketosis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Ketone Ester	Flavored sports drink containing deltaG (betahydroxybutyrate monoester) as the sole active ingredient, diluted with water.
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.

Timeline

• Start date: 2018-09-01
• Primary completion: 2018-10-31
• Completion: 2018-11-15
• First posted: 2018-09-06
• Last updated: 2018-09-06