20 Participants Needed

Ketogenic Food Products for Oxygen Toxicity

BD
DG
AS
Overseen ByAbha Singh

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?

BD

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
See 1 more

Exclusion Criteria

I have had a collapsed lung or air leak in the chest before.
Claustrophobia
Prolonged QTc on initial ECG
See 15 more

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?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental: Ketogenic food productsExperimental Treatment1 Intervention
Group II: Control: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

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+
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