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Dietary Supplement

Ketogenic Food Products for Diver's Oxygen Toxicity

N/A
Waitlist Available
Led By Bruce Derrick, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males & females between 18 and 39 years old
Predicted (Phase 1) VO2max ≥ 30 ml/kg/min (female) or 35 ml/kg/min (male)
Must not have
Seizures
Previous pneumothorax or pneumomediastinum
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial will study how ketogenic food products may help reduce oxygen toxicity in divers, which can cause seizures and other symptoms. It could help improve safety for Navy divers and submariners.

Who is the study for?
This trial is for men and women aged 18-39 with good exercise capacity (VO2max criteria) and a BMI ≤ 30, or appropriate VO2max and exercise profile. It's not for those with ear compression issues, heart disease, exercise intolerance, significant smoking history, electrolyte disorders, lung disease, hypertension, seizures or psychiatric conditions deemed significant by the PI.
What is being tested?
The study tests if ketogenic food products can delay or prevent oxygen toxicity in the brain when divers breathe high-pressure oxygen. Oxygen toxicity can cause symptoms like vision changes and seizures. The goal is to improve safety for undersea divers.
What are the potential side effects?
While specific side effects of ketogenic food products are not detailed here, such diets may sometimes lead to digestive discomforts like constipation or diarrhea initially as well as potential nutrient deficiencies over time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 39 years old.
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My estimated max oxygen uptake is above the threshold for my gender.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I experience seizures.
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I have had a collapsed lung or air leak in the chest before.
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I have diabetes.
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I have been diagnosed with coronary artery disease.
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I have a known serious imbalance in my body's salt levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in serum acetoacetate levels.
Secondary study objectives
Tolerability of ketone food product ingestion measured by adverse events

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Ketogenic food products one timeExperimental Treatment1 Intervention
Dietary Supplement: Ketogenic food products Participants will be given a ketogenic food product prior to the hyperbaric oxygen exposure.
Group II: Experimental: Ketogenic food products two timesExperimental Treatment1 Intervention
Dietary Supplement: Ketogenic food products Participants will be given a ketogenic food product prior to the hyperbaric oxygen exposure.
Group III: Experimental: Ketogenic food products three timesExperimental Treatment1 Intervention
Dietary Supplement: Ketogenic food products Participants will be given a ketogenic food product prior to the hyperbaric oxygen exposure.

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,451 Previous Clinical Trials
2,971,744 Total Patients Enrolled
2 Trials studying Oxygen Toxicity
82 Patients Enrolled for Oxygen Toxicity
United States NavyFED
2 Previous Clinical Trials
240 Total Patients Enrolled
1 Trials studying Oxygen Toxicity
20 Patients Enrolled for Oxygen Toxicity
Bruce Derrick, MDPrincipal InvestigatorDuke Health
1 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Oxygen Toxicity
20 Patients Enrolled for Oxygen Toxicity
~1 spots leftby Dec 2024
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