Ketogenic Diet for Reduction of CNS Oxygen Toxicity in Working Divers

NCT03433261 | Completed

• 1 other identifier: Pro00070499
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

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 will provide a starting point to develop methods for improving the safety of Navy divers, warfighters and submariners.

Conditions

CNS Oxygen Toxicity, Ketogenic Diet

Outcome Measures

Primary Outcomes (1)

• Time to First Manifestations of CNS Oxygen Toxicity

  Time to the first manifestation of CNS Oxygen Toxicity: visual or hearing changes, nausea, twitching, irritability, dizziness, convulsions or change consistent with possible CNS Oxygen Toxicity.

  2 hrs

Study Arms (2)

Normal Diet

NO INTERVENTION

The participant will eat their usual diet for at least 72 hrs prior to the experiment, document their diet during that time and be tested for ketone level immediately prior to the experiment.

Ketogenic Diet

EXPERIMENTAL

The participant will follow a ketogenic diet for 72 hrs prior to the experiment and consume a ketone supplement 60 minutes prior to the experiment. They will document their diet and be tested for ketone level immediately prior to the experiment.

Dietary Supplement: Ketogenic Diet

Interventions

Ketogenic Diet DIETARY_SUPPLEMENT

Eat a ketogenic diet (low carbohydrate, high fat diet) for 72 hrs prior to the experiment and consume a dietary ketone supplement 60 minutes before the experiment.

Ketogenic Diet

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males \& females between 18 and 50 years old
• Able to pedal a bicycle ergometer continuously for 15 minutes
• Non-smoker
• No history of cardiovascular disease, including coronary artery disease, valvular disease, cardiomyopathy or hypertension.
• No history of lung disease

You may not qualify if:

• Prolonged QTc on initial ECG
• Currently pregnant or attempting to become pregnant.
• Have a history of:
• Smoking
• Coronary artery disease
• Hypertension
• Seizures
• Exercise intolerance
• Psychiatric disorder
• Previous pneumothorax or pneumomediastinum
• Hypo or hyperglycemia
• Diabetes
• Regularly take any medications which may alter heart rate, blood pressure, neurotransmitter function, mood or affect.

Sponsors & Collaborators

• Duke University: lead
• United States Department of Defense: collaborator

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Interventions

Diet, Ketogenic

Intervention Hierarchy (Ancestors)

Diet, Carbohydrate-Restricted; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Neither the investigator nor the outcomes assessor will no the ketone level of the participant during either arm of the study
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each subject will randomize to one of two arms and will crossover to the other arm at least one week later.

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 14, 2018
• Study Start: March 1, 2018
• Primary Completion: October 30, 2021
• Study Completion: October 30, 2021
• Last Updated: December 14, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)