Biodiesel Exhaust, Acute Vascular and Endothelial Responses

NCT ID: NCT01337882

Last Updated: 2011-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2011-11-30

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.

Conditions

Healthy

Keywords

Air Pollution; Diesel exhaust; Biodiesel exhaust; Vascular function; Fibrinolysis; Acute vascular and endothelial responses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Diesel exhaust exposure

1 hour exposure to dilute diesel exhaust (approximate PM10 concentration 300 mcg/m3) during intermittent exercise

Group Type: EXPERIMENTAL

Forearm venous occlusion plethysmography study

Intervention Type: 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.

Biodiesel exhaust exposure

1 hour exposure to dilute biodiesel exhaust (approximate PM10 concentration 300 mcg/m3) during intermittent exercise

Group Type: EXPERIMENTAL

Forearm venous occlusion plethysmography study

Intervention Type: 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.

Interventions

Forearm venous occlusion plethysmography study

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Umeå University

OTHER

Sponsor Role: collaborator

University of Edinburgh

OTHER

Sponsor Role: lead

Responsible Party

Jeremy Langrish

Clinical Lecturer and Specialty Registrar in Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jenny A Bosson Damewood, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Umeå University

Locations

Umeå University Hospital

Umeå, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 34127003 (View on PubMed)

Other Identifiers

BEAVER

Identifier Type: -

Identifier Source: org_study_id