Pulmonary Effects of 100% Biodiesel Exhaust

Study Overview
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Brief Summary
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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.

Official Title
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Pulmonary Effects of 100% Biodiesel Exhaust

Conditions
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Inflammation

Intervention / Treatment
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* Other: Bronchoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Filtered air exposure<br>One hour exposure to filtered air during intermittent exercise in controlled chamber, 6 hours after exposure bronchoscopy is performed. | Other: Bronchoscopy<br>* The bronchoscopy procedure was performed six hours after completion of the exposure session, with sampling of endobronchial mucosal biopsies, bronchial wash and bronchoalveolar lavage performed under topical anaesthesia.<br>|
| Experimental: Biodiesel exhaust exposure<br>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. | Other: Bronchoscopy<br>* The bronchoscopy procedure was performed six hours after completion of the exposure session, with sampling of endobronchial mucosal biopsies, bronchial wash and bronchoalveolar lavage performed under topical anaesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytokines in Bronchial wash (BW) | Bronchial wash (BW) collected by bronchoscopy will be analyzed for cytokines (%). | 6 hours | 
| Cell counts in Bronchial Wash | Bronchial wash (BW) collected by bronchoscopy will be analyzed for inflammatory cell counts (cells/ml). | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxylipin Metabolomic profiling | Metabolomic testing done with mass spectrometry on blood samples, BW and BAL. | Baseline, 2 hours, 6 hours, 24 hours | 
| Inflammation in bronchoalveolar lavage (BAL) | BAL collected by bronchoscopy will be analyzed for inflammatory markers, such as cell counts (cells/ml). | 6 hour | 
| Inflammation in endomucosal biopsies | Biopsies collected by bronchoscopy will be analyzed for inflammatory markers, such as cell counts (cells/mm2). | 6 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Air Pollution, Biodiesel exhaust, Bronchoscopy, Metabolomics