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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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 hours

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

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

Primary outcome measures

Change in acetone levels

Change in beta hydroxybutyrate levels

Change in serum acetoacetate levels.

Secondary outcome measures

Tolerability of ketone food product ingestion measured by adverse events

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,359 Previous Clinical Trials

3,420,207 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

Frequently Asked Questions

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

What criteria must be met in order to participate in this clinical experiment?

"In order to be accepted in this study, prospective participants must have oxygen toxicity and lie between the ages of 18-39. Thus far, 15 individuals have been admitted into this trial."

Answered by AI

How many individuals have enrolled in this clinical investigation?

"Affirmative. Clinicaltrials.gov displays that this experiment, initially advertised on May 1st 2023, is presently recruiting individuals to participate. The project necessitates 15 volunteers from a single trial site."

Answered by AI

Does this experimentation accept participants younger than seventy years old?

"The age range for this particular trial is 18-39. For patients younger than that, there are 3 studies available and 13 trials offered to those aged 65 or higher."

Answered by AI

Is enrollment for this clinical trial still available?

"Indeed, the information hosted on clinicaltrials.gov shows that this medical trial is actively recruiting participants. It was initially posted online on May 1st 2023 and has been recently updated on May 11th of the same year. The study aims to recruit 15 patients from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effects of Pre-dive Ketone Food Products on Latency to CNS Oxygen Toxicity (Aim 1)

2023. "Effects of Pre-dive Ketone Food Products on Latency to CNS Oxygen Toxicity (Aim 1)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05801120.

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