Hypoxia, Ketosis
Conditions
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.
Interventions
DIETARY_SUPPLEMENTKetone Ester
Flavored sports drink containing deltaG (betahydroxybutyrate monoester) as the sole active ingredient, diluted with water.
DIETARY_SUPPLEMENTTaste Matched Placebo
Placebo that tastes similar to active intervention
OTHERHypoxic exposure
Participants will breath through a mask to provide the amount of oxygen typically seen at 16-17,000ft of altitude.
Sponsors
Florida Institute for Human and Machine Cognition
HVMN Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Study drinks will be matched for taste and appearance. Investigator preparing and administering the drink will not carry out the testing.
Intervention model description
Young healthy adults.
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
\* Pass medical examination on enrollment.
Exclusion criteria
\* Active smoker, substance abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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- 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- 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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 |
Outcome results
None listed