Clinical trial NCT01337882: Biodiesel Exhaust, Acute Vascular and Endothelial Responses
Official title: Inhalation of Dilute Biodiesel Exhaust: Acute Vascular and Endothelial Responses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Air Pollution
Diesel exhaust
Biodiesel exhaust
Vascular function
Fibrinolysis
Acute vascular and endothelial responses
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: Umeå University
First posted: 2011-04-19
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Vascular vasomotor and fibrinolytic function
timeFrame: 4-6 hours after exposure
Secondary outcomes:
measure: Respiratory function tests
timeFrame: 6 hours after exposure
measure: Inflammatory markers
timeFrame: Baseline and up to 24 hours after exposure
measure: Central arterial stiffness
timeFrame: Baseline and post exposure
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå University Hospital
Study officials:
affiliation: Umeå University
name: Jenny A Bosson Damewood, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Unosson J, Kabele M, Boman C, Nystrom R, Sadiktsis I, Westerholm R, Mudway IS, Purdie E, Raftis J, Miller MR, Mills NL, Newby DE, Blomberg A, Sandstrom T, Bosson JA. Acute cardiovascular effects of controlled exposure to dilute Petrodiesel and biodiesel exhaust in healthy volunteers: a crossover study. Part Fibre Toxicol. 2021 Jun 14;18(1):22. doi: 10.1186/s12989-021-00412-3.