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Dietary Supplement

Ketogenic Food Products for 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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours

Summary

"This trial aims to study how ketogenic food products can help reduce the negative effects of breathing high levels of oxygen underwater for divers. Oxygen toxicity can cause various symptoms such as vision problems, nausea, and seizures

Who is the study for?
This trial is for men and women aged 18-39 who are in good physical shape, as shown by a VO2max test. They must have a BMI of 30 or less unless their exercise profile fits the study's needs. Participants should be able to handle a 2-hour bike workout and withstand pressure changes in a hyperbaric chamber.
What is being tested?
The study tests if ketogenic food products can delay or prevent oxygen toxicity symptoms like vision issues, ear-ringing, nausea, twitching, dizziness, or seizures that divers experience at high pressures. A placebo group serves as the control to compare effects.
What are the potential side effects?
While not explicitly stated for this trial, ketogenic products may cause digestive changes such as constipation or diarrhea initially. Oxygen toxicity can lead to serious symptoms including seizures; however, this risk is part of what's being studied.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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
Latency to central nervous system oxygen toxicity (CNSOT)
Secondary study objectives
Change in end-tidal CO2
Change in heart rate
Change in qEEG alpha/delta power ratio (ratio of power in alpha frequency band to power in delta frequency band)
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental: Ketogenic food productsExperimental Treatment1 Intervention
Dietary Supplement: Ketogenic food products Participants will be given a ketogenic food product prior to the hyperbaric oxygen exposure.
Group II: Control: PlaceboPlacebo Group1 Intervention
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Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,454 Previous Clinical Trials
2,971,591 Total Patients Enrolled
2 Trials studying Oxygen Toxicity
77 Patients Enrolled for Oxygen Toxicity
United States NavyFED
2 Previous Clinical Trials
235 Total Patients Enrolled
1 Trials studying Oxygen Toxicity
15 Patients Enrolled for Oxygen Toxicity
Bruce Derrick, MDPrincipal InvestigatorDuke Health
1 Previous Clinical Trials
15 Total Patients Enrolled
1 Trials studying Oxygen Toxicity
15 Patients Enrolled for Oxygen Toxicity
~4 spots leftby Mar 2025
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