Pulmonary Effects of 100% Biodiesel Exhaust (BD100Broncho)
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.
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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偽コンパレータ：Filtered air exposure
One hour exposure to filtered air during intermittent exercise in controlled chamber, 6 hours after exposure bronchoscopy is performed.
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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.
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実験的：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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cytokines in Bronchial wash (BW)
時間枠：6 hours
|
Bronchial wash (BW) collected by bronchoscopy will be analyzed for cytokines (%).
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6 hours
|
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Cell counts in Bronchial Wash
時間枠：6 hours
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Bronchial wash (BW) collected by bronchoscopy will be analyzed for inflammatory cell counts (cells/ml).
|
6 hours
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Oxylipin Metabolomic profiling
時間枠：Baseline, 2 hours, 6 hours, 24 hours
|
Metabolomic testing done with mass spectrometry on blood samples, BW and BAL.
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Baseline, 2 hours, 6 hours, 24 hours
|
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Inflammation in bronchoalveolar lavage (BAL)
時間枠：6 hour
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BAL collected by bronchoscopy will be analyzed for inflammatory markers, such as cell counts (cells/ml).
|
6 hour
|
|
Inflammation in endomucosal biopsies
時間枠：6 hours
|
Biopsies collected by bronchoscopy will be analyzed for inflammatory markers, such as cell counts (cells/mm2).
|
6 hours
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。