- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05801120
Effects of Pre-dive Ketone Food Products on Latency to CNS Oxygen Toxicity (Aim 1)
Effects of Pre-dive Ketone Food Products on Latency to Central Nervous System Oxygen Toxicity
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Central nervous system (CNS) oxygen toxicity continues to be a risk for military divers and constrains their operations. Manifestations of this condition range from nausea, twitching, and tinnitus to seizures and unresponsiveness, and the latter may lead to death by drowning. The NAVY has a need for better methods to prevent or delay the onset of CNS oxygen toxicity (CNSOT) and to safely expand the scope of diving operations. It is the broad objective of this study to generate information that will enhance warfighter safety and performance in relevant NAVY operations by reducing the risk of CNS oxygen toxicity.
It is known that nutritional ketosis through a diet with a high fat-to-carbohydrate ratio (ketogenic diet) can reduce the frequency and severity of epileptic seizures in humans, and a recent animal study has shown that dietary ketosis also delays the onset of CNSOT. In recent years, ketone ester food products ketone esters have been made commercially available which may elevate circulating ketone levels. The investigators aim to investigate whether ketosis from commercially available ketogenic food products prior to a dive will delay the onset of CNSOT.
The first aim of this study will be to determine the effect of ketone food product ingestion on serum ketone levels, and document any relevant side effects. Post-ingestion ketone levels will be trended for 3 different ketone food product regimens in 15 total subjects. Data will be used to select the optimal ketone food product strategy to investigate in the second aim which will be registered separately.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Males & females between 18 and 39 years old.
- Predicted (Phase 1) VO2max ≥ 30 ml/kg/min (female) or 35 ml/kg/min (male).
- BMI ≤ 30.0 unless VO2max and baseline exercise profile is deemed appropriate for the study by the PI.
Exclusion Criteria:
- Prolonged QTc on initial ECG
- Currently pregnant or attempting to become pregnant.
Have a medical history of:
- Smoking history deemed significant by PI
- Known significant electrolyte disorders
- Coronary artery disease
- Cardiac arrhythmia deemed significant by PI
- Lung disease
- Hypertension
- Seizures
- Exercise intolerance or inability to meet inclusion requirements
- Psychiatric disorder deemed significant by PI
- Previous pneumothorax or pneumomediastinum
- Hypo- or hyperglycemia
- Diabetes
- Inability to equalize middle ear spaces during hyperbaric compression
- Claustrophobia
- Regularly take any medications which may alter heart rate, blood pressure, neurotransmitter function, alter seizure threshold, mood or affect per PI discretion.
- Any other condition limiting ability to perform exercise testing or dive profile as determined by the investigators.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ketogenic food products one time
Dietary Supplement: Ketogenic food products Participants will be given a ketogenic food product prior to the hyperbaric oxygen exposure.
|
Participants will be given a ketogenic food product prior to the hyperbaric oxygen exposure.
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Experimental: Experimental: Ketogenic food products two times
Dietary Supplement: Ketogenic food products Participants will be given a ketogenic food product prior to the hyperbaric oxygen exposure.
|
Participants will be given a ketogenic food product prior to the hyperbaric oxygen exposure.
|
Experimental: Experimental: Ketogenic food products three times
Dietary Supplement: Ketogenic food products Participants will be given a ketogenic food product prior to the hyperbaric oxygen exposure.
|
Participants will be given a ketogenic food product prior to the hyperbaric oxygen exposure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in serum acetoacetate levels.
Time Frame: over 6 hours
|
Assess serum ketone levels over the course of 6 hours after the ingestion of ketone food products.
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over 6 hours
|
Change in beta hydroxybutyrate levels
Time Frame: over 6 hours
|
over 6 hours
|
|
Change in acetone levels
Time Frame: over 6 hours
|
over 6 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tolerability of ketone food product ingestion measured by adverse events
Time Frame: 24 hours
|
Assessment of side effects which may impair a working diver over a period of 24 hours.
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24 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bruce Derrick, MD, Duke Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00111000
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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