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NCT Number: NCT01337882

Biodiesel Exhaust, Acute Vascular and Endothelial Responses

Exposure to particulate air pollution has been shown to increase cardiovascular mortality and morbidity, and in previous controlled exposure studies has been shown to have acute cardiovascular and respiratory effects. The last decade has seen an unprecedented drive towards finding a bioeconomical and renewable source of fuel in order to reduce our dependence on fossil fuels. Although both biodiesel and bioethanol have emerged as contenders for future fuels, biodiesel remains as the strongest contender within European markets. In 2007 researchers at the EPA released a commentary, which concluded that the assumed correlation between the chemical composition of biodiesel exhaust and a reduction in health effects was only hypothetical. They suggested that there was a clear need for the study of health effects in humans regarding biofuel exhaust. In this project the investigators aim to investigate the cardiovascular, respiratory and inflammatory responses to biofuel exhaust exposure in healthy volunteers.

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Key information

Conditions

Healthy

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Umeå University Hospital

Umeå, 901 85, Sweden

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 20 healthy, non-smoking subjects, age 20-55 year old, both genders.

All subjects undergo a general health examination and are required to have:

Normal clinical examination Normal EKG Normal routine blood tests Normal lung function

Exclusion criteria

  • Cardiovascular disease
  • Diabetes Mellitus
  • Asthma and/or allergy
  • Respiratory infection within 3 weeks of the study
  • Antioxidant- and/or vitamin supplementation within 2 weeks prior to, as well as during the course of the study. (incl vitamin C, Acetylcysteine)
  • Female subjects will take a urinary pregnancy test before each exposure and will be excluded if this is positive.

Treatment and study plan

Forearm venous occlusion plethysmography study

Other

Forearm venous occlusion plethysmography to measure forearm blood flow during unilateral intrabrachial infusion of endothelium-dependent (bradykinin [100, 300 & 1000 pmol/min]; acetylcholine [5, 10 & 20 µg/min]) and -independent [sodium nitroprusside [2, 4 & 8 µg/min]; verapamil [10, 30 & 100 µg/min]) vasodilators. Each drug to be infused for 6 mins at each dose in increasing concentrations. 0.9% sodium chloride will be infused for 20 min between each individual drug to allow washout.

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 (bradykinin and acetylcholine) and -independent (sodium nitroprusside and verapamil) vasodilators. Fibrinolytic function assessed by blood sampling after infusion of bradykinin for tissue plasminogen activator and plasminogen activator inhibitor-1.

Secondary outcomes

  1. Respiratory function tests

    Time frame: 6 hours after exposure

    Basic spirometry will be performed at baseline and 6 hours after each exposure

  2. Inflammatory markers

    Time frame: Baseline and up to 24 hours after exposure

    Blood samples will be taken and stored as plasma and serum for measurement of inflammatory mediators

  3. Central arterial stiffness

    Time frame: Baseline and post exposure

    Central arterial stiffness (PWV and PWA) will be measured at baseline and immediately after the exposure

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • Umeå University

Registry information

Official study title

Inhalation of Dilute Biodiesel Exhaust: Acute Vascular and Endothelial Responses

Acronym: BEAVER

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 19, 2011
Registry last updated
Dec 1, 2011

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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