Acute Health Effects Due to Ultrafine Particles From Candles and Cooking

Sponsor
University of Aarhus (Other)
Overall Status
Completed
CT.gov ID
NCT04315740
Collaborator
University of Copenhagen (Other), Aarhus University Hospital (Other)
36
1
3
8.6
4.2

Study Details

Study Description

Brief Summary

People spend up to 90% of their life indoor, and the way we live and behave in our homes has substantial effects on our health and well-being. Particle contamination is suggested to have substantial negative effects on health, with candles and cooking emitting the largest amount of particles, thus being the largest contributors to indoor air pollution.

The overall aim of the present project is to contribute to increased understanding of the association between indoor particulate air pollution and health and well-being.

Condition or Disease Intervention/Treatment Phase
  • Other: Particles from candles
  • Other: Particles from cooking
  • Other: Clean Air
N/A

Detailed Description

Introduction: People spend up to 90% of their life indoor, and the way we live and behave in our homes has substantial effects on our health and well-being. Particle contamination is suggested to have substantial negative effects on health, with candles and cooking emitting the largest amount of particles, thus being the largest contributors to indoor air pollution. Little is known about the potential adverse health effects of candles and cooking, and people with asthma may be more susceptible.

Aim: To investigate local and systemic effects of short-term exposure to lit candles and cooking among young asthmatics.

Design: In a randomised double-blinded cross-over study non-smoking asthmatics (18-25 years) were exposed for five hours at three different exposure conditions separated by 14 days; A) clean filtered air, B) lit candles and C) cooking emissions under controlled environmental conditions.

Measurements: TSI P-TRAK Ultrafine Particle Counter was used for particle counts. Health effects, including lung function (FEV1/FVC) and fraction of exhaled nitric oxide (FeNO) were evaluated in relation to local and systemic effects prior to, right after and 24 h. after exposure.

Analysis: Mixed methods approach taking both time and exposure into account.

Study Design

Study Type:
Interventional
Actual Enrollment :
36 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
A randomised double-blinded crossover studyA randomised double-blinded crossover study
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
The exposure was generated in small adjacent chamber and thereby led into the exposure chamber using a pipe connection and a small negative pressure. Thus, the exposure could not be observed.
Primary Purpose:
Prevention
Official Title:
THE ULTRAFINE PROJECT - A Study of Acute Health Effects of Exposure to Particles Generated by Candles and Cooking
Actual Study Start Date :
Apr 1, 2019
Actual Primary Completion Date :
Dec 20, 2019
Actual Study Completion Date :
Dec 20, 2019

Arms and Interventions

Arm Intervention/Treatment
Sham Comparator: Clean Air

Just clean air - no exposure

Other: Clean Air
Nothing but clean air

Experimental: Cooking

Four ovens were frying pork - one at a time. When the first oven finished, the next oven started and so forth for approx. 7 hours.

Other: Particles from cooking
Generating fine and ultrafine particles from frying pork in an oven

Experimental: Candles

10 lit candles were placed at a table. Burning for approx. 7 hours with light ventilation.

Other: Particles from candles
Generating fine and ultrafine particles from lit candles

Outcome Measures

Primary Outcome Measures

  1. Change in Particles in Exhaled Air (Surfactant Protein A & Albumin) [Time Frame: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)]

    PExA: Subjects performed repeated breath maneuvers allowing for airway closure and re-opening, and exhaled particles were optically counted and collected on a membrane using the (novel) PExA® instrument set-up.

Secondary Outcome Measures

  1. Change in Lung Function (FEV1 & FVC) [At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)]

    Spirometry

  2. Change in Fractional exhaled nitric oxide (FENO) [At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)]

    NIOX VERO system; Aerocrine AB, Sweden

  3. Change in Blood samples [At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)]

    Cytokines (IL-8), DNA-damages

  4. Change in nasal volume (using Acoustic rhinometry) [At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)]

    Is used to assess the nasal cross sectional area and volume. The left and right nasal cavity were studied alternatively until three reproducible measurements were obtained. The minimum cross sectional cavity area was calculated from the means of the measurements. By integration of the area-distance curve, the sum of the volume 2 to 4 (vol2-4) from the nostril was determined on both sides.

  5. Change in biomarkers in Saliva Sample [At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)]

    An oral svap from Salivette was placed in the mouth of the participant to collect saliva by gently chewing the swab for one minute. Afterwards the saturated swab was removed to the suspended insert and closed firmly with a lid. Then the sample was transferred to a freezer and stored for -80 C until further analysis. The sample will be analyzed for biomarkers (amylase, cortisol, substance P, lysozyme and secretory IgA.)

  6. Change in Subjective Symptoms [Every 30 minute during 5 hours of exposure]

    In the exposure chamber participants were asked to fill out a symptom questionnaire every 30 minute regarding their well-being and experienced symptoms in eyes, nose and throat. The participants were asked to score their evaluation (rate the strength) of symptoms by placing a cross on a 130 mm open Visual Analogue Scale (VAS). The intensity of any discomfort was registered as the length in mm from the left of the scale to the marker. The scores were rated from 0 to 100% with highest number corresponding to highest discomfort. Health effects were evaluated in relation to rated changes in symptoms.

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Aged 15-25

  • Medically treated / physician diagnosed mild seasonal asthma

  • Never smoker or ex-smoker ≥ 6 months

  • Allergy > 1 common allergy

Exclusion Criteria:
  • Any other disease that could influence the study parameters

  • Conditions that prevent safe access to the climate chambers (such as claustrophobia)

  • Perennial asthma

  • Need for continuous medical treatment for asthma

  • Pregnancy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Climate Chambers, Dept. Public Health, Aarhus University Aarhus Central Region Denmark Denmark 8000

Sponsors and Collaborators

  • University of Aarhus
  • University of Copenhagen
  • Aarhus University Hospital

Investigators

  • Principal Investigator: Karin R Laursen, MSc, Department of Public Health, Aarhus Universitet

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Torben Sigsgaard, Professor, University of Aarhus
ClinicalTrials.gov Identifier:
NCT04315740
Other Study ID Numbers:
  • 191100
First Posted:
Mar 19, 2020
Last Update Posted:
Nov 6, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Torben Sigsgaard, Professor, University of Aarhus

Study Results

No Results Posted as of Nov 6, 2020