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Ketone snacks could protect navy divers from brain seizures

NCT ID NCT05831228

Knowledge-focused Sponsor: Duke University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether eating ketone-rich foods before a dive could delay oxygen toxicity in the brain, a risk for divers breathing high-pressure oxygen. Twenty healthy adults exercised in a pressure chamber while breathing pure oxygen. Researchers measured how long it took for symptoms like dizziness or seizures to appear. The goal is to find practical ways to make diving safer for Navy personnel.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

Sep 2023

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 39 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Males \& females between 18 and 39 years old. * Measured (Phase 2) VO2max ≥ 30 ml/kg/min (female) or 35 ml/kg/min (male). * BMI ≤ 30.0 unless VO2max and baseline exercise profile is deemed appropriate for the study by the PI. * (Phase 2 only) Able to exercise continuously on cycle ergometer for 2 hours. * (Phase 2 only) Able to equalize middle ears and tolerate hyperbaric chamber exposure test. Exclusion Criteria: * Prolonged QTc on initial ECG * Currently pregnant or attempting to become pregnant. * Have a medical history of: 1. Smoking history deemed significant by PI 2. Known significant electrolyte disorders 3. Coronary artery disease 4. Cardiac arrhythmia deemed significant by PI 5. Lung disease 6. Hypertension 7. Seizures 8. Exercise intolerance or inability to meet inclusion requirements 9. Psychiatric disorder deemed significant by PI 10. Previous pneumothorax or pneumomediastinum 11. Hypo- or hyperglycemia 12. Diabetes 13. Inability to equalize middle ear spaces during hyperbaric compression 14. Claustrophobia * Regularly take any medications which may alter heart rate, blood pressure, neurotransmitter function, alter seizure threshold, mood or affect per PI discretion. * Any other condition limiting ability to perform exercise testing or dive profile as determined by the investigators.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Oxygen toxicity

Contacts and locations

Locations

  • Duke University Hospital

    Durham, North Carolina, 27710, United States

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