Effects of Pre-dive Ketone Food Products on Latency to CNS Oxygen Toxicity (Aim 2)
Completed · Not applicable · Has a placebo group
Conditions studied: Oxygen Toxicity
In brief
The purpose of this study is to understand how ketogenic food products affect oxygen toxicity in undersea divers. Oxygen toxicity affecting the central nervous system, mainly the brain, is a result of breathing higher than normal oxygen levels at elevated pressures as can be seen in SCUBA diving or inside a hyperbaric (pressure) chamber. This is a condition that may cause a wide variety of symptoms such as: vision disturbances, ear-ringing, nausea, twitching, irritability, dizziness, and potentially loss of consciousness or seizure. Because nutritional ketosis has been used to reduce or eliminate seizures in humans, it may be beneficial to reduce oxygen toxicity as well. The investigators hope this study will provide a help to develop practical and useful methods for improving the safety of undersea Navy divers, warfighters and submariners.
Key facts
- Study ID
- NCT05831228
- Run by
- Duke University
- People needed
- 20
- Starts
- 2023-09-01
- Expected to finish
- 2025-03-31
- Last updated by the study team
- 2026-04-03
Who can join
Age: 18 and older, up to 39. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Males \& females between 18 and 39 years old.
- Measured (Phase 2) VO2max ≥ 30 ml/kg/min (female) or 35 ml/kg/min (male).
- BMI ≤ 30.0 unless VO2max and baseline exercise profile is deemed appropriate for the study by the PI.
- (Phase 2 only) Able to exercise continuously on cycle ergometer for 2 hours.
- (Phase 2 only) Able to equalize middle ears and tolerate hyperbaric chamber exposure test.
You may not qualify if…
- Prolonged QTc on initial ECG
- Currently pregnant or attempting to become pregnant.
- Have a medical history of:
- Smoking history deemed significant by PI
- Known significant electrolyte disorders
- Coronary artery disease
- Cardiac arrhythmia deemed significant by PI
- Lung disease
- Hypertension
- Seizures
- Exercise intolerance or inability to meet inclusion requirements
- Psychiatric disorder deemed significant by PI
- Previous pneumothorax or pneumomediastinum
- Hypo- or hyperglycemia
- Diabetes
- Inability to equalize middle ear spaces during hyperbaric compression
- Claustrophobia
- Regularly take any medications which may alter heart rate, blood pressure, neurotransmitter function, alter seizure threshold, mood or affect per PI discretion.
- Any other condition limiting ability to perform exercise testing or dive profile as determined by the investigators.
Where it is running
- Duke University Hospital — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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