Ketogenic Diet for Reduction of CNS Oxygen Toxicity in Working Divers

Ketogenic Diet for Reduction of 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.

Study Overview

• Status: Completed
• Conditions: CNS Oxygen Toxicity, Ketogenic Diet
• Intervention / Treatment: Dietary supplement: Ketogenic Diet

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 Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 hrs

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: United States Department of Defense

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2018
• Primary Completion (ACTUAL): October 30, 2021
• Study Completion (ACTUAL): October 30, 2021

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: February 8, 2018
• First Posted (ACTUAL): February 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 14, 2021
• Last Update Submitted That Met QC Criteria: November 30, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Hyperoxia
• Other Study ID Numbers: Pro00070499

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No