Ketone Esters for Optimization of Cognitive Performance in Hypoxia
- Conditions
- HypoxiaKetosis
- Interventions
- Dietary Supplement: Taste Matched PlaceboDietary Supplement: Ketone EsterOther: Hypoxic exposure
- Registration Number
- NCT03659825
- Lead Sponsor
- HVMN Inc
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 16
* Pass medical examination on enrollment.
* Active smoker, substance abuse.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo + Normoxia Taste Matched Placebo Taste, volume and appearance matched drink given before cognitive testing in normoxia Placebo + Hypoxia Hypoxic exposure Taste, volume and appearance matched drink given before cognitive testing in hypoxia Ketone Ester + Normoxia Ketone Ester Ketone ester drink given before cognitive testing in normoxia Ketone Ester + Hypoxia Ketone Ester Ketone ester drink given before cognitive testing in hypoxia Ketone Ester + Hypoxia Hypoxic exposure Ketone ester drink given before cognitive testing in hypoxia Placebo + Hypoxia Taste Matched Placebo Taste, volume and appearance matched drink given before cognitive testing in hypoxia
- Primary Outcome Measures
Name Time Method Change in Cognitive Performance- Visual Acuity 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).
Change in Cognitive Performance- Eye Tracking- Smooth Pursuit 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).
Change in Cognitive Performance- Eye Tracking- Saccades 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).
Change in Cognitive Performance- Contrast Sensitivity 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).
Change in Cognitive Performance- Simple Reaction Time 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).
Change in Cognitive Performance- Choice Reaction Time 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).
- Secondary Outcome Measures
Name Time Method Change in blood glucose levels 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).
Change in Grip Strength 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
Change in blood ketone levels 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).