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

NCT05801120 | Completed

• 1 other identifier: Pro00111000
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oxygen Toxicity

Outcome Measures

Primary Outcomes (3)

• Change in serum acetoacetate levels.

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

  over 6 hours

• Change in beta hydroxybutyrate levels

  over 6 hours

• Change in acetone levels

  over 6 hours

Secondary Outcomes (1)

• Tolerability of ketone food product ingestion measured by adverse events

  24 hours

Study Arms (3)

Ketogenic food products one time

EXPERIMENTAL

Dietary Supplement: Ketogenic food products Participants will be given a ketogenic food product prior to the hyperbaric oxygen exposure.

Dietary Supplement: Ketogenic food products

Experimental: Ketogenic food products two times

EXPERIMENTAL

Dietary Supplement: Ketogenic food products Participants will be given a ketogenic food product prior to the hyperbaric oxygen exposure.

Dietary Supplement: Ketogenic food products

Experimental: Ketogenic food products three times

EXPERIMENTAL

Dietary Supplement: Ketogenic food products Participants will be given a ketogenic food product prior to the hyperbaric oxygen exposure.

Dietary Supplement: Ketogenic food products

Interventions

Ketogenic food products DIETARY_SUPPLEMENT

Participants will be given a ketogenic food product prior to the hyperbaric oxygen exposure.

Experimental: Ketogenic food products three times; Experimental: Ketogenic food products two times; Ketogenic food products one time

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males \& females between 18 and 39 years old.
• Predicted (Phase 1) 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.

You may not qualify if:

• Prolonged QTc on initial ECG
• Currently pregnant or attempting to become pregnant.
• Have a medical history of:
• Smoking history deemed significant by PI
• Known significant electrolyte disorders
• Coronary artery disease
• Cardiac arrhythmia deemed significant by PI
• Lung disease
• Hypertension
• Seizures
• Psychiatric disorder deemed significant by PI
• Previous pneumothorax or pneumomediastinum
• Hypo- or hyperglycemia
• Diabetes
• Inability to equalize middle ear spaces during hyperbaric compression

Sponsors & Collaborators

• Duke University: lead
• United States Navy: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Study Officials

• Bruce Derrick, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 6, 2023
• Study Start: May 1, 2023
• Primary Completion: January 5, 2024
• Study Completion: January 5, 2024
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)