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OpenTrials
Completed

NCT Number: NCT03433261

Ketogenic Diet for Reduction of CNS Oxygen Toxicity in Working Divers

The purpose of this research study is to understand the effect of nutritional ketosis on CNS oxygen toxicity in undersea divers. The investigators hope this will provide a starting point to develop methods for improving the safety of Navy divers, warfighters and submariners.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Hospital

Durham, North Carolina, 27710, United States

About this study

Participants in the study will undergo a physical exam and testing as well as training on cognitive testing software as part of the screening process. Eligible subjects will be assigned a normal diet or a ketogenic diet (a diet high in fat/protein and low in carbohydrates) for three days before testing. Subjects will be immersed in water to the shoulders, inside a hyperbaric (high pressure) chamber while breathing 100% oxygen at increased atmospheric pressure, and doing cycling exercise. Testing on the cognitive software, as well as blood sampling and physical monitoring will be done while in the chamber. All tests and procedures will be completed again at least one week later with the diet not assigned for the first session.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males & females between 18 and 50 years old
  • Able to pedal a bicycle ergometer continuously for 15 minutes
  • Non-smoker
  • No history of cardiovascular disease, including coronary artery disease, valvular disease, cardiomyopathy or hypertension.
  • No history of lung disease

Exclusion criteria

  • Prolonged QTc on initial ECG
  • Currently pregnant or attempting to become pregnant.
  • Have a history of:
  • Smoking
  • Coronary artery disease
  • Hypertension
  • Seizures
  • Exercise intolerance
  • Psychiatric disorder
  • Previous pneumothorax or pneumomediastinum
  • Hypo or hyperglycemia
  • Diabetes
  • Regularly take any medications which may alter heart rate, blood pressure, neurotransmitter function, mood or affect.

Treatment and study plan

Ketogenic diet

Dietary Supplement

Eat a ketogenic diet (low carbohydrate, high fat diet) for 72 hrs prior to the experiment and consume a dietary ketone supplement 60 minutes before the experiment.

Primary outcomes

  1. Time to First Manifestations of CNS Oxygen Toxicity

    Time frame: 2 hrs

    Time to the first manifestation of CNS Oxygen Toxicity: visual or hearing changes, nausea, twitching, irritability, dizziness, convulsions or change consistent with possible CNS Oxygen Toxicity.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

Ketogenic Diet for Reduction of Oxygen Toxicity in Working Divers

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Feb 14, 2018
Registry last updated
Dec 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.