Ketogenic Diet for Reduction of CNS Oxygen Toxicity in Working Divers

CNS Oxygen Toxicity, Ketogenic Diet Clinical Trial

Official title:

Ketogenic Diet for Reduction of Oxygen Toxicity in Working Divers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03433261
• Other study ID #: Pro00070499
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: October 30, 2021

Study information

• Verified date: November 2021
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: October 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• CNS Oxygen Toxicity, Ketogenic Diet
• Hyperoxia

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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