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NCT05801120 · ClinicalTrials.gov registry record · NA

Effects of Pre-dive Ketone Food Products on Latency to CNS Oxygen Toxicity (Aim 1)

A NA study, sponsored by Duke University.

Completed
Registry status
NA
Development phase
15
Enrollment target

NCT05801120: Completed NA study, sponsored by Duke University.

NCT05801120 is a NA study that has completed, run by Duke University. The registered enrollment target is 15 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.

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The verdict

NCT05801120, a NA study, has completed, sponsored by Duke University.

COMPLETED
Registry status
NA
Development phase
15 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

Assess serum ketone levels over the course of 6 hours after the ingestion of ketone food products.

Interventions

  • DIETARY_SUPPLEMENT Ketogenic food products

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2023-05-01
Est. Completion 2024-01-05
Phase NA
Duke University

1,725 total trials

What the finished NCT05801120 record still lists

NCT05801120 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 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 1 intervention - of which Ketogenic food products is the first listed.

NCT05801120 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05801120 about?

NCT05801120 is a clinical study titled "Effects of Pre-dive Ketone Food Products on Latency to CNS Oxygen Toxicity (Aim 1)". 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 NCT05801120?

This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2023-05-01. Estimated completion is 2024-01-05.

What interventions are being tested in trial NCT05801120?

The interventions under investigation include: Ketogenic food products (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT05801120?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05801120's enrollment target sits among peer trials

15 1881st of 2000 higher than 92 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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Source: ClinicalTrials.gov NCT05801120, the US trial registry maintained by the National Library of Medicine. NCT05801120 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.