Ketogenic Diet for Reduction of CNS Oxygen Toxicity in Working Divers

Not Applicable

Completed

• Conditions: CNS Oxygen Toxicity, Ketogenic Diet
• Interventions: Dietary Supplement: Ketogenic Diet

• Registration Number: NCT03433261
• Lead Sponsor: Duke University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2018-01-29
• Study First Submitted QC: 2018-02-08
• Study First Posted: 2018-02-14
• Study Start: 2018-03-01
• Primary Completion: 2021-10-30
• Study Completion: 2021-10-30
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-30
• Last Update Posted: 2021-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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

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Exclusion Criteria

• Prolonged QTc on initial ECG

• Currently pregnant or attempting to become pregnant.

• Have a history of:

  1. Smoking
  2. Coronary artery disease
  3. Hypertension
  4. Seizures
  5. Exercise intolerance
  6. Psychiatric disorder
  7. Previous pneumothorax or pneumomediastinum
  8. Hypo or hyperglycemia
  9. Diabetes

• Regularly take any medications which may alter heart rate, blood pressure, neurotransmitter function, mood or affect.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ketogenic Diet	Ketogenic Diet	The participant will follow a ketogenic diet for 72 hrs prior to the experiment and consume a ketone supplement 60 minutes prior to the experiment. They will document their diet and be tested for ketone level immediately prior to the experiment.

Primary Outcome Measures

Name	Time	Method
Time to First Manifestations of CNS Oxygen Toxicity	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.

Trial Locations

Locations (1)

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States