Impact of Inspired Oxygen on Oxidative Stress and Breath Volatile Organic Compound Composition in Healthy Volunteers: A Randomized Controlled Cross-over Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in exhaled breath oxidative stress biomarker
研究概览
简要总结
High inspiratory oxygen fractions are known to induce oxidative stress and lipid peroxidation. The degrading products of oxidative stress induced lipid peroxidation are in part volatile and appear in breath where they can be measured non-invasively. However, there is lack of knowledge on the correlation of blood and breath biomarkers of oxidative stress.
This study aims to investigate the effects of a high inspiratory oxygen fraction on oxidative stress in healthy volunteers. The primary outcome is the appearance of exhaled breath biomarkers of oxidative stress by electrochemical sensors and ion mobility mass spectrometry. Secondary outcomes are changes in oxidative stress biomarkers in blood and their relationship to breath biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy male volunteers who have given an oral and written informed consent
排除标准
- •smoker or ex-smoker
- •any pulmonary disease
- •any heart disease
- •any chemotherapy in the past
- •any kind of daily medication
研究组 & 干预措施
Oxygen
Day 1: breathing of 100% oxygen; Day 2: ambient air breathing
干预措施: Ambient (Other)
Ambient
Day 1: breathing of 100% oxygen; Day 2: ambient air breathing
干预措施: Ambient (Other)
Oxygen
Day 1: breathing of 100% oxygen; Day 2: ambient air breathing
干预措施: Oxygen (Other)
Ambient
Day 1: breathing of 100% oxygen; Day 2: ambient air breathing
干预措施: Oxygen (Other)
结局指标
主要结局
Change in exhaled breath oxidative stress biomarker
时间窗: 1, 4, and 24 hour
Measurement of oxidative stress biomarkers in breath e.g. acetaldehyde, ethan, malondialdheyde, propionaldehyde, pentane
次要结局
- Change in blood oxidative stress biomarkers(1, 4, and 24 hour)
研究者
Michael Dolch
Dr. med.
Klinikum der Universitaet Muenchen, Grosshadern
