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Dietary Supplement

Experimental: 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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 hours

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Latency to central nervous system oxygen toxicity (CNSOT)

Secondary outcome measures

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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Who is running the clinical trial?

Duke UniversityLead Sponsor

2,365 Previous Clinical Trials

3,420,620 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential candidates able to apply for participation in this ongoing trial?

"The current status on clinicaltrials.gov indicates that patient recruitment for this particular trial is not ongoing. This study was initially posted on September 1st, 2023, with the most recent update made on March 5th, 2024. Although enrollment is currently closed for this investigation, there are a total of nineteen other trials actively seeking participants."

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Are individuals who are 85 years of age and older eligible to participate in this clinical trial?

"Patients must be between 18 and 39 years old to meet the enrollment criteria for this clinical investigation."

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Which individuals are eligible to partake in this research investigation?

"Individuals aged between 18 and 39 who demonstrate signs of oxygen toxicity are eligible to enroll in this study, which aims to admit approximately 20 participants."

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Recent research and studies

clinicaltrials.govStudy

Effects of Pre-dive Ketone Food Products on Latency to CNS Oxygen Toxicity (Aim 2)

2023. "Effects of Pre-dive Ketone Food Products on Latency to CNS Oxygen Toxicity (Aim 2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05831228.

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