Ketogenic Diet for Reduction of Oxygen Toxicity in Working Divers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Time to First Manifestations of CNS Oxygen Toxicity
研究概览
简要总结
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.
详细描述
Participants in the study will undergo a physical exam and testing as well as training on cognitive testing software as part of the screening process. Eligible subjects will be assigned a normal diet or a ketogenic diet (a diet high in fat/protein and low in carbohydrates) for three days before testing. Subjects will be immersed in water to the shoulders, inside a hyperbaric (high pressure) chamber while breathing 100% oxygen at increased atmospheric pressure, and doing cycling exercise. Testing on the cognitive software, as well as blood sampling and physical monitoring will be done while in the chamber. All tests and procedures will be completed again at least one week later with the diet not assigned for the first session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Neither the investigator nor the outcomes assessor will no the ketone level of the participant during either arm of the study
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Prolonged QTc on initial ECG
- •Currently pregnant or attempting to become pregnant.
- •Have a history of:
- •Coronary artery disease
- •Hypertension
- •Exercise intolerance
- •Psychiatric disorder
- •Previous pneumothorax or pneumomediastinum
- •Hypo or hyperglycemia
- •Regularly take any medications which may alter heart rate, blood pressure, neurotransmitter function, mood or affect.
结局指标
主要结局
Time to First Manifestations of CNS Oxygen Toxicity
时间窗: 2 hrs
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.
次要结局
未报告次要终点