Pulmonary Effects of 100% Biodiesel Exhaust
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Umeå University
临床试验: NCT02690571
BioSeek: nct02690571
关键词
抽象
Air pollution is a global environmental and health concern, contributing to onset and deterioration of respiratory and cardiovascular diseases. As climate change and dependence on diminishing fossil fuel supplies have taken center stage in political and scientific debates, renewable carbon-neutral fuels like biodiesel receive increasing attention. The most common biodiesel within the European Union, rapeseed oil methyl ester (RME) is perceived to be a "green fuel", as it is sustainable and of biological origin, and therefore is often predicted to be less harmful to human health. Whilst replacing petrodiesel with biodiesel may have advantageous ecological impacts, consequences to respiratory health remained largely unexplored.
The purpose of the current study is to evaluate whether inhalation of 100% RME biodiesel exhaust would result in an acute airway inflammatory response in healthy human subjects, as shown previously following exposure to petrodiesel exhaust.
日期
| 最后验证: | 02/29/2016 |
| 首次提交: | 02/08/2016 |
| 提交的预估入学人数: | 02/22/2016 |
| 首次发布: | 02/23/2016 |
| 上次提交的更新: | 03/17/2016 |
| 最近更新发布: | 03/20/2016 |
| 实际学习开始日期: | 09/30/2013 |
| 预计主要完成日期: | 03/31/2014 |
| 预计完成日期: | 03/31/2014 |
状况或疾病
Inflammation
干预/治疗
Other: Bronchoscopy
相
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手臂组
| 臂 | 干预/治疗 |
|---|---|
| Sham Comparator: Filtered air exposure One hour exposure to filtered air during intermittent exercise in controlled chamber, 6 hours after exposure bronchoscopy is performed. | |
| Experimental: Biodiesel exhaust exposure One hour exposure to biodiesel exhaust (generated at same running conditions as earlier studies with diesel exhaust at approximate particle matter concentration 300 mcg/m3) during intermittent exercise in controlled chamber. Six hours after exposure bronchoscopy is performed. |
资格标准
| 有资格学习的年龄 | 20 Years 至 20 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: Normal ECG Normal Lung function Normal Blood samples Exclusion Criteria: Smoking Pre-existing metabolomic, respiratory and cardiovascular disease Exposure to high levels of pollutants in occupation |
结果
主要结果指标
1. Cytokines in Bronchial wash (BW) [6 hours]
Bronchial wash (BW) collected by bronchoscopy will be analyzed for cytokines (%).
2. Cell counts in Bronchial Wash [6 hours]
Bronchial wash (BW) collected by bronchoscopy will be analyzed for inflammatory cell counts (cells/ml).
次要成果指标
1. Oxylipin Metabolomic profiling [Baseline, 2 hours, 6 hours, 24 hours]
Metabolomic testing done with mass spectrometry on blood samples, BW and BAL.
2. Inflammation in bronchoalveolar lavage (BAL) [6 hour]
BAL collected by bronchoscopy will be analyzed for inflammatory markers, such as cell counts (cells/ml).
3. Inflammation in endomucosal biopsies [6 hours]
Biopsies collected by bronchoscopy will be analyzed for inflammatory markers, such as cell counts (cells/mm2).
