Ketogenic Food Products for Diver's Oxygen Toxicity

Recruiting in Palo Alto (17 mi)

Overseen byBruce Derrick, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Duke University

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for men and women aged 18-39 with good exercise capacity (VO2max criteria) and a BMI ≤ 30, or appropriate VO2max and exercise profile. It's not for those with ear compression issues, heart disease, exercise intolerance, significant smoking history, electrolyte disorders, lung disease, hypertension, seizures or psychiatric conditions deemed significant by the PI.

Inclusion Criteria

I am between 18 and 39 years old.

Your body mass index (BMI) is less than 30, unless the study doctor thinks your fitness level is good for the study.

My estimated max oxygen uptake is above the threshold for my gender.

Exclusion Criteria

You have a medical condition that makes it difficult for you to do exercise testing or diving.

I experience seizures.

You have a mental health condition that the Principal Investigator thinks is important.

+15 more

Participant Groups

The study tests if ketogenic food products can delay or prevent oxygen toxicity in the brain when divers breathe high-pressure oxygen. Oxygen toxicity can cause symptoms like vision changes and seizures. The goal is to improve safety for undersea divers.

3Treatment groups

Experimental Treatment

Group I: Ketogenic food products one timeExperimental Treatment1 Intervention

Dietary Supplement: Ketogenic food products Participants will be given a ketogenic food product prior to the hyperbaric oxygen exposure.

Group II: Experimental: Ketogenic food products two timesExperimental Treatment1 Intervention

Dietary Supplement: Ketogenic food products Participants will be given a ketogenic food product prior to the hyperbaric oxygen exposure.

Group III: Experimental: Ketogenic food products three timesExperimental Treatment1 Intervention

Dietary Supplement: Ketogenic food products Participants will be given a ketogenic food product prior to the hyperbaric oxygen exposure.