Status:
COMPLETED
Ketogenic Diet for Reduction of CNS Oxygen Toxicity in Working Divers
Lead Sponsor:
Duke University
Collaborating Sponsors:
United States Department of Defense
Conditions:
CNS Oxygen Toxicity, Ketogenic Diet
Eligibility:
All Genders
18-50 years
Phase:
NA
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 me...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2021
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT03433261
Start Date
March 1 2018
End Date
October 30 2021
Last Update
December 14 2021
Active Locations (1)
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1
Duke University Hospital
Durham, North Carolina, United States, 27710