Ketogenic Diet for Reduction of CNS Oxygen Toxicity in Working Divers
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|ClinicalTrials.gov Identifier: NCT03433261|
Recruitment Status : Suspended (Due to COVID-19 temporary suspension of in-person, non-essential research at Duke)
First Posted : February 14, 2018
Last Update Posted : May 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|CNS Oxygen Toxicity, Ketogenic Diet||Dietary Supplement: Ketogenic Diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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|
|Official Title:||Ketogenic Diet for Reduction of Oxygen Toxicity in Working Divers|
|Actual Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||October 31, 2020|
|Estimated Study Completion Date :||October 31, 2020|
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.
- 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.
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
|United States, North Carolina|
|Duke University Hospital|
|Durham, North Carolina, United States, 27710|