Ketogenic Diet for Reduction of CNS Oxygen Toxicity in Working Divers
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ClinicalTrials.gov Identifier: NCT03433261 |
Recruitment Status :
Completed
First Posted : February 14, 2018
Last Update Posted : December 14, 2021
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Condition or disease | Intervention/treatment | Phase |
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CNS Oxygen Toxicity, Ketogenic Diet | Dietary Supplement: Ketogenic Diet | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 91 participants |
Allocation: | Randomized |
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 |
Primary Purpose: | Prevention |
Official Title: | Ketogenic Diet for Reduction of Oxygen Toxicity in Working Divers |
Actual Study Start Date : | March 1, 2018 |
Actual Primary Completion Date : | October 30, 2021 |
Actual Study Completion Date : | October 30, 2021 |

Arm | Intervention/treatment |
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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.
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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.
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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.

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.
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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.

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 |
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT03433261 |
Other Study ID Numbers: |
Pro00070499 |
First Posted: | February 14, 2018 Key Record Dates |
Last Update Posted: | December 14, 2021 |
Last Verified: | November 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hyperoxia Signs and Symptoms, Respiratory |