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Completed

NCT Number: NCT01883466

Health Effects of Biodiesel Exhaust Exposure

Urban air pollution is a major contributor to greenhouse gases and has been shown to increase cardiovascular mortality and morbidity. This century has seen a rebirth of biofuel marketing and research, with biodiesel emerging as one of the strongest contenders within international markets. The pursuit of alternative renewable fuels is incredibly complex and has powered research in agriculture, biotechnology, production, transportation, feedstocks, ecology and biomass manufacturing. In spite of this, health effects have been an almost completely overlooked aspect. The purpose of this study is to investigate whether 100% biodiesel exhaust exposure in healthy volunteers leads to cardiovascular and inflammatory responses. Further investigations into the chemical composition of biodiesel exhaust will also be performed.

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Key information

Conditions

Vascular Endothelium

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Umeå University Hospital

Umeå, 90185, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Non-smoking, healthy male subjects. All subjects undergo a general health examination and are required to have normal clinical examination, ECG, blood tests and lung function.

Exclusion criteria

  • Diabetes Mellitus
  • Cardiovascular disease
  • Asthma
  • Respiratory infection within 2 weeks of the study
  • Antioxidant- and/or vitamin supplementation within 1 week prior to, as well as during the course of the study. (incl vitamin C, Acetylcysteine)
  • Smokers or regular snus usage

Treatment and study plan

Forearm venous occlusion plethysmography study

Other

Measurement of forearm blood flow during unilateral intrabrachial infusion of four vasodilator drugs in incremental doses separated with 20-min washout periods. Bradykinin (endothelial-dependent vasodilator that releases t-PA) was infused at 100, 300 and 1000 pmol/min; acetylcholine (endothelial independent vasodilator that does not release t-PA) was infused at 5, 10 and 20 mcg/min; sodium nitroprusside (endothelial independent vasodilator that does not release t-PA) was infused at 2, 4 and 8 mcg/min and verapamil (endothelial independent and NO independent vasodilator that does not release t-PA) was infused at 10, 30 and 100 mcg/min. Bradykinin, acetylcholine and sodium nitroprusside were given in random order and verapamil was administered last due to its long acting effects.

Primary outcomes

  1. Vascular vasomotor and fibrinolytic function

    Time frame: 4-6 hours after exposure

    Forearm venous occlusion plethysmography to measure forearm blood flow during unilateral intrabrachial infusion of endothelial-dependent and -independent vasodilators (bradykinin & acetylcholine and sodium nitroprusside & verapamil respectively). Tissue plasminogen activator and plasminogen activator inhibitor-1 were analysed in blood samples taken after bradykinin infusions in order to assess fibrinolytic function. These composite outcome measures will together indicate vascular vasomotor function.

Secondary outcomes

  1. Respiratory function tests

    Time frame: Baseline, 6 and 24 hours after exposure

    Basic spirometry and fraction of exhaled nitric oxide (FeNO) are performed at baseline, as well as 6 and 24 hours after exposure.

  2. Effects of exposure on metabolomic markers in plasma

    Time frame: Baseline and 2, 4 & 24 hours after exposure

    Blood samples taken at baseline as well as at 2, 4 and 24 hours post-exposure will be stored as plasma for metabolomic analysis. Since inflammatory mediators such as eicosanoids and other fatty acid metabolites have been seen as likely key players in air pollution response, particular interest will be directed towards the oxylipin metabolome, which will be analyzed according to established protocols. These samples are taken in EDTA tubes and placed on ice. They are centrifuged at a low temperature and then divided into 1ml allotments. These are then stored in a freezer until analysis.

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • University of Edinburgh

Registry information

Official study title

Cardiovascular Effects of Exposure to 100% Biodiesel Exhaust in Man

Acronym: BD100

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 21, 2013
Registry last updated
Jun 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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