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NCT05831228 · ClinicalTrials.gov registry record · NA
Effects of Pre-dive Ketone Food Products on Latency to CNS Oxygen Toxicity (Aim 2)
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT05831228: Completed NA study, sponsored by Duke University.
NCT05831228 is a NA study that has completed, run by Duke University. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05831228, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Assessment of latency to CNSOT in a simulated working dive breathing 100% oxygen at 2.06 ATA, immersed in water (head out), in a hyperbaric chamber while performing exercise. Endpoint is time to development of signs or symptoms of CNSOT. Maximum duration 120 minutes.
Interventions
- DIETARY_SUPPLEMENT Control: Placebo
- DIETARY_SUPPLEMENT Ketogenic food products
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-09-01 |
| Est. Completion | 2025-03-31 |
| Phase | NA |
What the finished NCT05831228 record still lists
NCT05831228 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Control: Placebo is the first listed.
NCT05831228 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05831228 about?
NCT05831228 is a clinical study titled "Effects of Pre-dive Ketone Food Products on Latency to CNS Oxygen Toxicity (Aim 2)". 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 ...
What is the current status of trial NCT05831228?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2023-09-01. Estimated completion is 2025-03-31.
What interventions are being tested in trial NCT05831228?
The interventions under investigation include: Control: Placebo (DIETARY_SUPPLEMENT), Ketogenic food products (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT05831228?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05831228's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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