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Ketogenic Diet for Reduction of CNS Oxygen Toxicity in Working Divers

Primary Purpose

CNS Oxygen Toxicity, Ketogenic Diet

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ketogenic Diet
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for CNS Oxygen Toxicity, Ketogenic Diet

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Duke University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Normal Diet

Ketogenic Diet

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Time to First Manifestations of CNS Oxygen Toxicity
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.

Secondary Outcome Measures

Full Information

First Posted
January 29, 2018
Last Updated
November 30, 2021
Sponsor
Duke University
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT03433261
Brief Title
Ketogenic Diet for Reduction of CNS Oxygen Toxicity in Working Divers
Official Title
Ketogenic Diet for Reduction of Oxygen Toxicity in Working Divers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
October 30, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CNS Oxygen Toxicity, Ketogenic Diet

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Each subject will randomize to one of two arms and will crossover to the other arm at least one week later.
Masking
InvestigatorOutcomes Assessor
Masking Description
Neither the investigator nor the outcomes assessor will no the ketone level of the participant during either arm of the study
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal Diet
Arm Type
No Intervention
Arm Description
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.
Arm Title
Ketogenic Diet
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketogenic Diet
Intervention Description
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 Measure Information:
Title
Time to First Manifestations of CNS Oxygen Toxicity
Description
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.
Time Frame
2 hrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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: 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.
Facility Information:
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Ketogenic Diet for Reduction of CNS Oxygen Toxicity in Working Divers

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