Ketone Esters for Optimization of Cognitive Performance in Hypoxia

Hypoxia Clinical Trial

Official title:

Ketone Esters for Optimization of Cognitive Performance in Hypoxia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03659825
• Other study ID #: KEHYPOX18
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: November 15, 2018

Study information

• Verified date: August 2018
• Source: HVMN Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 16
• Est. completion date: November 15, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Pass medical examination on enrollment.

Exclusion Criteria:

• Active smoker, substance abuse.

Related Conditions & MeSH terms

• Hypoxia
• Ketosis

Intervention

Dietary Supplement:
• Ketone Ester
Flavored sports drink containing deltaG (betahydroxybutyrate monoester) as the sole active ingredient, diluted with water.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
HVMN Inc	Florida Institute of Human and Machine Cognition

References & Publications (4)

Kirsch JR, D'Alecy LG, Mongroo PB. Butanediol induced ketosis increases tolerance to hypoxia in the mouse. Stroke. 1980 Sep-Oct;11(5):506-13. — View Citation

Stubbs BJ, Cox PJ, Evans RD, Santer P, Miller JJ, Faull OK, Magor-Elliott S, Hiyama S, Stirling M, Clarke K. On the Metabolism of Exogenous Ketones in Humans. Front Physiol. 2017 Oct 30;8:848. doi: 10.3389/fphys.2017.00848. eCollection 2017. — View Citation

Suzuki M, Suzuki M, Sato K, Dohi S, Sato T, Matsuura A, Hiraide A. Effect of beta-hydroxybutyrate, a cerebral function improving agent, on cerebral hypoxia, anoxia and ischemia in mice and rats. Jpn J Pharmacol. 2001 Oct;87(2):143-50. — View Citation

Xu K, Sun X, Eroku BO, Tsipis CP, Puchowicz MA, LaManna JC. Diet-induced ketosis improves cognitive performance in aged rats. Adv Exp Med Biol. 2010;662:71-5. doi: 10.1007/978-1-4419-1241-1_9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cognitive Performance- Visual Acuity	Cognitive performance (visual acuity) will be assessed using the RightEye testing system (https://www.righteye.com).	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.
Primary	Change in Cognitive Performance- Contrast Sensitivity	Cognitive performance (contrast sensitivity) will be assessed using the RightEye testing system (https://www.righteye.com).	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.
Primary	Change in Cognitive Performance- Choice Reaction Time	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).	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.
Primary	Change in Cognitive Performance- Eye Tracking- Smooth Pursuit	Cognitive performance (eye tracking) will be assessed by looking for smooth pursuit (horizontal and vertical) using the RightEye testing system (https://www.righteye.com).	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.
Primary	Change in Cognitive Performance- Eye Tracking- Saccades	Cognitive performance (eye tracking) will be assessed by looking at saccade speed (horizontal and vertical) using the RightEye testing system (https://www.righteye.com).	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.
Primary	Change in Cognitive Performance- Simple Reaction Time	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).	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	Change in Grip Strength	Grip strength will be measured using a	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.
Secondary	Change in blood ketone levels	Blood ketone levels will be measured in a finger prick blood samples using a clinical grade, handheld glucose/ketone meter (Abott Diabetes Care).	Measured 5 times at regular intervals through each of the two study visits. [time (min) = 0, 30, 75, 105, 150]
Secondary	Change in blood glucose levels	Blood glucose levels will be measured in a finger prick blood samples using a clinical grade, handheld glucose/ketone meter (Abott Diabetes Care).	Measured 5 times at regular intervals through each of the two study visits. [time (min) = 0, 30, 75, 105, 150]

External Links

•   HVMN product website