Ketogenic Food Products for Oxygen Toxicity

Overseen By Abha Singh

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must not be taking: Heart rate, Blood pressure, Neurotransmitter, Seizure

Disqualifiers: Pregnancy, Lung disease, Hypertension, Seizures, Diabetes, others

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how ketogenic food products might reduce oxygen toxicity in divers. Oxygen toxicity can cause symptoms such as dizziness, nausea, or even seizures when divers inhale excessive oxygen at high pressures. Since ketogenic diets have been known to help with seizures, the study aims to determine if they can enhance diving safety. Ideal participants are experienced divers who can equalize ear pressure and endure long periods of exercise, such as cycling for two hours. As an unphased trial, this study offers divers a unique opportunity to contribute to groundbreaking research that could improve diving safety.

Will I have to stop taking my current medications?

If you regularly take medications that affect heart rate, blood pressure, brain chemicals, or mood, you may need to stop them to participate in this trial. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ketogenic foods might help with oxygen toxicity, which can affect divers who breathe high levels of oxygen. One study found that ketosis, a state the body enters on a ketogenic diet, delayed seizures in rats exposed to high-pressure oxygen. This finding suggests that ketogenic diets might help manage symptoms of oxygen toxicity, such as nausea or dizziness.

Regarding safety, ketogenic diets are generally well-tolerated. They have been safely used to treat conditions like epilepsy, especially in children. Some individuals may experience mild side effects, such as tiredness or headaches, when starting the diet, but these usually improve as the body adjusts.

While more research is needed, current studies in animals and past use in humans show promise for the safety and potential benefits of ketogenic foods in managing oxygen toxicity. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for oxygen toxicity, which typically involves managing symptoms and adjusting oxygen exposure, ketogenic food products offer a unique approach. These products work by altering the body's metabolism to use fat instead of carbohydrates for energy, potentially providing protective benefits against oxygen toxicity during hyperbaric oxygen exposure. Researchers are excited because this metabolic shift could reduce oxidative stress and inflammation more effectively than current methods, offering a novel way to protect cells and improve patient outcomes.

What evidence suggests that ketogenic food products might be an effective treatment for oxygen toxicity?

Research shows that ketogenic diets, which prompt the body to burn fat instead of carbohydrates, might help reduce symptoms of oxygen toxicity. Past studies found that the ketogenic diet delayed or prevented seizures caused by oxygen toxicity in the central nervous system of animals. This finding is significant because seizures are a serious symptom of oxygen toxicity in divers. Additionally, nutritional ketosis has effectively controlled seizures in people with epilepsy, suggesting it might also benefit divers exposed to high oxygen levels. In this trial, participants in the experimental arm will receive ketogenic food products to assess their potential in making diving safer by lowering the risk of harmful symptoms. ^{2 3 6 7 8}

Who Is on the Research Team?

Bruce Derrick, MD

Principal Investigator

Duke Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

BMI ≤ 30.0 unless VO2max and baseline exercise profile is deemed appropriate for the study by the PI

(Phase 2 only) Able to exercise continuously on cycle ergometer for 2 hours

My exercise capacity test shows I am fit.

Exclusion Criteria

I have had a collapsed lung or air leak in the chest before.

Claustrophobia

Prolonged QTc on initial ECG

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-dive Ketone Ingestion

Participants ingest ketone food products to assess serum ketone levels and document side effects

1 day

1 visit (in-person)

Hyperbaric Oxygen Exposure

Participants undergo hyperbaric oxygen exposure while exercising to assess latency to CNS oxygen toxicity

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after hyperbaric exposure

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Control
• Ketogenic food products

Trial Overview

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.

How Is the Trial Designed?

Group I: Experimental: Ketogenic food products Experimental Treatment 1 Intervention

Dietary Supplement: Ketogenic food products Participants will be given a ketogenic food product prior to the hyperbaric oxygen exposure.

Group II: Control: Placebo Placebo Group 1 Intervention

Dietary Supplement comparator

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

United States Navy

Collaborator

Trials

3

Recruited

260+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03433261

Ketogenic Diet for Reduction of CNS Oxygen Toxicity in ...

The purpose of this research study is to understand the effect of nutritional ketosis on CNS oxygen toxicity in undersea divers. The investigators hope this ...

2.

withpower.com

withpower.com/trial/phase-hyperoxia-4-2023-e9b5f

Ketogenic Food Products for Oxygen Toxicity

Trial Overview The study tests if ketogenic food products can delay or prevent oxygen toxicity symptoms like vision issues, ear-ringing, nausea, twitching, ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5805750/

Effects of the Ketogenic diet in overweight divers breathing ...

Central Nervous System Oxygen Toxicity (CNS-OT) is one of the most harmful effects of Enriched Air Nitrox (EAN) diving.

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S096999612100084X

The ketogenic diet raises brain oxygen levels, attenuates ...

Therapeutic ketosis with ketone ester delays central nervous system oxygen toxicity seizures in rats. Am. J. Phys. Regul. Integr. Comp. Phys., 304 (2013), pp ...

5.

journal.pan.olsztyn.pl

journal.pan.olsztyn.pl/Current-Perspective-About-the-Effect-of-a-Ketogenic-Diet-on-Oxidative-Stress-a-Review,185366,0,2.html

Current Perspective About the Effect of a Ketogenic Diet on ...

Such damages have the potential to induce cell death through various mechanisms, either by inhibiting crucial processes or by upregulating toxic cascades.

6.

anesthesiology.duke.edu

anesthesiology.duke.edu/hyperbaric-center/research/ketogenic

Ketogenic Diet for Oxygen Toxicity Research Study

Ketogenic Diet for Oxygen Toxicity Research Study ... A study is being conducted in the hyperbaric chambers of the Center for Hyperbaric Medicine and ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6317287/

Delaying latency to hyperbaric oxygen‐induced CNS oxygen ...

Delaying latency to hyperbaric oxygen‐induced CNS oxygen toxicity seizures by combinations of exogenous ketone supplements. Csilla Ari ...

8.

researchgate.net

researchgate.net/profile/Harry-Whelan/publication/264628877_Ketogenic_diet_for_high_partial_pressure_oxygen_diving/links/570700eb08aed73c8548a7d7/Ketogenic-diet-for-high-partial-pressure-oxygen-diving.pdf

Ketogenic diet for high partial pressure oxygen diving

Oxygen toxicity: In: Kindwall E, Whelan H, eds. Hyperbaric Medicine. Practice. 3rd Edition. Flagstaff, AZ: Best Publishing. Company. 2008; 69-82. 4. Wilder ...