Ketogenic Food Products for Oxygen Toxicity

Overseen By Abha Singh

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must not be taking: Heart rate, Blood pressure, Neurotransmitter, Seizure

Disqualifiers: Pregnancy, Lung disease, Hypertension, Seizures, Diabetes, others

Compensation: Varies

Number of Visits: 2

20 Participants Needed

What You Need to Know Before You Apply

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.

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

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.

(Phase 2 only) Able to exercise continuously on cycle ergometer for 2 hours

Exclusion Criteria

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

Claustrophobia

Prolonged QTc on initial ECG

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-dive Ketone Ingestion

Participants ingest ketone food products to assess serum ketone levels and document side effects

1 day

1 visit (in-person)

Hyperbaric Oxygen Exposure

Participants undergo hyperbaric oxygen exposure while exercising to assess latency to CNS oxygen toxicity

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after hyperbaric exposure

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Control
• Ketogenic food products

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.

How Is the Trial Designed?

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+

United States Navy

Collaborator

Trials

3

Recruited

260+