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Ketogenic Diet for Reduction of CNS Oxygen Toxicity in Working Divers

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ClinicalTrials.gov Identifier: NCT03433261
Recruitment Status : Recruiting
First Posted : February 14, 2018
Last Update Posted : January 31, 2019
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
CNS Oxygen Toxicity, Ketogenic Diet Dietary Supplement: Ketogenic Diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Each subject will randomize to one of two arms and will crossover to the other arm at least one week later.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Neither the investigator nor the outcomes assessor will no the ketone level of the participant during either arm of the study
Primary Purpose: Prevention
Official Title: Ketogenic Diet for Reduction of Oxygen Toxicity in Working Divers
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy

Arm Intervention/treatment
No Intervention: Normal Diet
The participant will eat their usual diet for at least 72 hrs prior to the experiment, document their diet during that time and be tested for ketone level immediately prior to the experiment.
Experimental: 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.
Dietary Supplement: Ketogenic Diet
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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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:

    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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03433261


Contacts
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Contact: Bruce Derrick, MD 919-684-6726 bruce.derrick@duke.edu
Contact: Michael Natoli, MS 919-668-0017 michael.natoli@duke.edu

Locations
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United States, North Carolina
Duke University Hospital Recruiting
Durham, North Carolina, United States, 27710
Contact: Michael Natoli, MS    919-668-0017    michael.natoli@duke.edu   
Contact: Richard Moon, MD    919-684-6726    richard.moon@duke.edu   
Duke University Hospital Recruiting
Durham, North Carolina, United States, 27710
Contact: Michael Natoli, MS    919-668-0017    michael.natoli@duke.edu   
Contact: Richard Moon, MD    9196846726    richard.moon@duke.edu   
Sponsors and Collaborators
Duke University
United States Department of Defense

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03433261     History of Changes
Other Study ID Numbers: Pro00070499
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hyperoxia
Signs and Symptoms, Respiratory
Signs and Symptoms