The aim of the project is to investigate the effects of five contrasting air pollution scenarios on respiratory and cardiovascular health of young healthy volunteers.
ID
Source
Brief title
Condition
- Haematological disorders NEC
- Cardiac disorders, signs and symptoms NEC
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Respiratory and cardiovascular health will be assessed before and after the
exposure. These will include recording of symptoms, spirometry (peakflow, FEV1,
FVC, FEF25-75), nasal lavage, exhaled NO and CO, blood pressure, oxygen
saturation in blood, heart rate, and blood sampling. Plasma samples and nasal
lavage will be analyzed on inflammation markers.
Secondary outcome
We will administer a time activity questionnaire to assess exposure to indoor
sources (e.g. smoking, cooking), participation in traffic, and time spent
outdoors. These measurements will be used to document the relative contribution
of pre- and post experiment exposures, compared to exposure during the
experiment.
Background summary
Numerous epidemiological studies have demonstrated health effects related to
short- and long-term exposure to elevated concentrations of ambient particulate
matter (PM). Well known is the association with respiratory and cardiovascular
effects. It is not clear, however, which specific characteristics of PM are
responsible for the observed effects, e.g. particle number, size, composition,
oxidative capacity.
Study objective
The aim of the project is to investigate the effects of five contrasting air
pollution scenarios on respiratory and cardiovascular health of young healthy
volunteers.
Study design
A panel of volunteers will participate in a total of 5 hours exposure to air
pollution at 5 different outdoor locations in the Netherlands. During this
exposure they will be asked to engage in mild-moderate exercise for a total of
1.7 hours (100 minuts of cycling on a hometrainer, spread over 5 hours). The
locations have high contrasts in, and low correlation among, major PM
components and their oxidative capacity, as established in a screening study.
Respiratory and cardiovascular health will be assessed before and after the
exercise. Air pollution, exposure to particulate matter and gasouses
pollutants, will be also characterized on-site.
Thirty-two healthy volunteers, 18-35 years old, will be recruited for the
study. Each potential participant will be asked to complete a screening
questionnaire prior to the enrolment in the study. Participant that meet the
in- and exclusion criteria are invited for a pre-test. Subsequently, each
volunteer will be tested seven times for the main study (exercise on location).
Study burden and risks
Pre-test (4 uur): record baseline information for every volunteer. To this end
we will use a questionnaire, a blood pressure measurement and a blood sample.
Furthermore, all test of the main study (including biking) will be performed
onces. This will be used to show potential participants the study procedure.
Main study: maximum of 7 measurements (11,5 hours per measurement) in de period
of spring 2009 until autum 2009. There will be at least 2.5 weeks inbetween two
measurements. A mesurement exists of a 5-hour exercise scheme: 20 minutes of
cycling on a hometrainer alternated with 40 minutes resting. The following test
will be performed before and after the exercise:
- Time-activity questionnaire: 2 hours before, and 18 hours after the exercise
(18 hours is the next morning)
- Blood pressure: 2 hours before, and 2 and 18 hours after the exercise
- Symptom questionnaire: 2 hours before and directly before; directly after, 2
and 18 hours after the exercise
- Long function: 2 hours before and directly before; directly after, 2 and 18
hours after the exercise
- Nitric oxide in exhaled air: 2 hours before and directly before; directly
after, 2 and 18 hours after the exercise
- Carbon monoxide in exhaled air: 2 hours before and directly before; directly
after, 2 and 18 hours after the
exercise
- Nasal lavage: 2 hours before, and 2 and 18 hours after the exercise
- Blood sample: 2 hours before, and 2 and 18 hours after the exercise
- Pulse and oxygen saturation: continiously during the exercise
Postbus 80.177
3508 TD Utrecht
Nederland
Postbus 80.177
3508 TD Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
healthy, non smoking, 18-35 years of age, living in students housing facilities at the campus of Utrecht University (de Uithof), good understanding of the Dutch language
Exclusion criteria
lifetime diagnosis asthma or COPD
recent wheeze, shortness of breath, chronic cough
history of high blood pressure, angina pectoris or myocardial infarction
medication for respiratory or cardiovascular disease
diabetes mellitus
obesity
smoking or living in a household with a smoker
pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL24102.041.08 |