Ketogenic Food Products for Oxygen Toxicity
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how ketogenic food products might reduce oxygen toxicity in divers. Oxygen toxicity can cause symptoms such as dizziness, nausea, or even seizures when divers inhale excessive oxygen at high pressures. Since ketogenic diets have been known to help with seizures, the study aims to determine if they can enhance diving safety. Ideal participants are experienced divers who can equalize ear pressure and endure long periods of exercise, such as cycling for two hours. As an unphased trial, this study offers divers a unique opportunity to contribute to groundbreaking research that could improve diving safety.
Will I have to stop taking my current medications?
If you regularly take medications that affect heart rate, blood pressure, brain chemicals, or mood, you may need to stop them to participate in this trial. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that ketogenic foods might help with oxygen toxicity, which can affect divers who breathe high levels of oxygen. One study found that ketosis, a state the body enters on a ketogenic diet, delayed seizures in rats exposed to high-pressure oxygen. This finding suggests that ketogenic diets might help manage symptoms of oxygen toxicity, such as nausea or dizziness.
Regarding safety, ketogenic diets are generally well-tolerated. They have been safely used to treat conditions like epilepsy, especially in children. Some individuals may experience mild side effects, such as tiredness or headaches, when starting the diet, but these usually improve as the body adjusts.
While more research is needed, current studies in animals and past use in humans show promise for the safety and potential benefits of ketogenic foods in managing oxygen toxicity.12345Why are researchers excited about this trial?
Unlike the standard of care for oxygen toxicity, which typically involves managing symptoms and adjusting oxygen exposure, ketogenic food products offer a unique approach. These products work by altering the body's metabolism to use fat instead of carbohydrates for energy, potentially providing protective benefits against oxygen toxicity during hyperbaric oxygen exposure. Researchers are excited because this metabolic shift could reduce oxidative stress and inflammation more effectively than current methods, offering a novel way to protect cells and improve patient outcomes.
What evidence suggests that ketogenic food products might be an effective treatment for oxygen toxicity?
Research shows that ketogenic diets, which prompt the body to burn fat instead of carbohydrates, might help reduce symptoms of oxygen toxicity. Past studies found that the ketogenic diet delayed or prevented seizures caused by oxygen toxicity in the central nervous system of animals. This finding is significant because seizures are a serious symptom of oxygen toxicity in divers. Additionally, nutritional ketosis has effectively controlled seizures in people with epilepsy, suggesting it might also benefit divers exposed to high oxygen levels. In this trial, participants in the experimental arm will receive ketogenic food products to assess their potential in making diving safer by lowering the risk of harmful symptoms.23678
Who Is on the Research Team?
Bruce Derrick, MD
Principal Investigator
Duke Health
Are You a Good Fit for This Trial?
This trial is for men and women aged 18-39 who are in good physical shape, as shown by a VO2max test. They must have a BMI of 30 or less unless their exercise profile fits the study's needs. Participants should be able to handle a 2-hour bike workout and withstand pressure changes in a hyperbaric chamber.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-dive Ketone Ingestion
Participants ingest ketone food products to assess serum ketone levels and document side effects
Hyperbaric Oxygen Exposure
Participants undergo hyperbaric oxygen exposure while exercising to assess latency to CNS oxygen toxicity
Follow-up
Participants are monitored for safety and effectiveness after hyperbaric exposure
What Are the Treatments Tested in This Trial?
Interventions
- Control
- Ketogenic food products
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
United States Navy
Collaborator