Ketogenic Food Products for Oxygen Toxicity

Recruiting in Palo Alto (17 mi)

Overseen by Bruce Derrick, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Duke University

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.

Research Team

Bruce Derrick, MD

Principal Investigator

Duke Health

Eligibility Criteria

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

I am between 18 and 39 years old.

BMI ≤ 30.0 unless VO2max and baseline exercise profile is deemed appropriate for the study by the PI

My exercise capacity test shows I am fit.

Exclusion Criteria

I have had a collapsed lung or air leak in the chest before.

Claustrophobia

Prolonged QTc on initial ECG

Treatment Details

Interventions

• Control (Dietary Supplement)
• Ketogenic food products (Dietary Supplement)

Trial Overview The study tests if ketogenic food products can delay or prevent oxygen toxicity symptoms like vision issues, ear-ringing, nausea, twitching, dizziness, or seizures that divers experience at high pressures. A placebo group serves as the control to compare effects.

Participant Groups

Group I: Experimental: Ketogenic food products Experimental Treatment 1 Intervention

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

Group II: Control: Placebo Placebo Group 1 Intervention

Dietary Supplement comparator

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Mary E. Klotman

Duke University

Chief Executive Officer since 2017

MD from Duke University School of Medicine

Michelle McMurry-Heath

Duke University

Chief Medical Officer since 2020

MD from Duke University School of Medicine

United States Navy

Collaborator

Trials

3

Recruited

260+