An interventional study of Ketogenic Diet in CNS Oxygen Toxicity, Ketogenic Diet, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-14.
Sponsored by Duke University · Not applicable, Interventional, and Prevention
The purpose of this research study is to understand the effect of nutritional ketosis on CNS oxygen toxicity in undersea divers. The investigators hope this will provide a starting point to develop methods for improving the safety of Navy divers, warfighters and submariners.
Participants in the study will undergo a physical exam and testing as well as training on cognitive testing software as part of the screening process. Eligible subjects will be assigned a normal diet or a ketogenic diet (a diet high in fat/protein and low in carbohydrates) for three days before testing. Subjects will be immersed in water to the shoulders, inside a hyperbaric (high pressure) chamber while breathing 100% oxygen at increased atmospheric pressure, and doing cycling exercise. Testing on the cognitive software, as well as blood sampling and physical monitoring will be done while in the chamber. All tests and procedures will be completed again at least one week later with the diet not assigned for the first session.
Exclusion Criteria:
Have a history of:
The participant will eat their usual diet for at least 72 hrs prior to the experiment, document their diet during that time and be tested for ketone level immediately prior to the experiment.
The participant will follow a ketogenic diet for 72 hrs prior to the experiment and consume a ketone supplement 60 minutes prior to the experiment. They will document their diet and be tested for ketone level immediately prior to the experiment.
Dietary Supplement: Ketogenic Diet
Eat a ketogenic diet (low carbohydrate, high fat diet) for 72 hrs prior to the experiment and consume a dietary ketone supplement 60 minutes before the experiment.
Time to First Manifestations of CNS Oxygen Toxicity
Time to the first manifestation of CNS Oxygen Toxicity: visual or hearing changes, nausea, twitching, irritability, dizziness, convulsions or change consistent with possible CNS Oxygen Toxicity.
Time frame: 2 hrs
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Duke University