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CompletedNCT04315740UltrafineUpdated Nov 6, 2020

Acute Health Effects Due to Ultrafine Particles From Candles and Cooking

An interventional study of Particles from candles and Particles from cooking in Candle Burning, Cooking and Lung Function Decreased, sponsored by University of Aarhus. Completed at 1 site in Denmark. Open to participants aged 15 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-06.

Sponsored by University of Aarhus · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 11 months after the study started (first participant enrolled Apr 2019, registered Mar 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
15 Years to 25 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Candle Burning
  • Cooking
  • Lung Function Decreased
  • DNA Damage
  • Subjective Health
  • Asthma

Keywords

  • Particle contamination
  • Indoor air
  • Acute health effects
  • RCT
  • Asthma
03

In context

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 25 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Sham comparator
    Clean Air

    Just clean air - no exposure

    Other: 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

  • Experimental
    Candles

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

    Other: Particles from candles

Interventions

  • OtherParticles from candles

    Generating fine and ultrafine particles from lit candles

  • OtherParticles from cooking

    Generating fine and ultrafine particles from frying pork in an oven

  • OtherClean Air

    Nothing but clean air

06

What researchers measure

Primary outcomes

  1. Change in Particles in Exhaled Air (Surfactant Protein A & Albumin)

    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.

    Time frame: Time Frame: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)

Secondary outcomes

  1. Change in Lung Function (FEV1 & FVC)

    Spirometry

    Time frame: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)

  2. Change in Fractional exhaled nitric oxide (FENO)

    NIOX VERO system; Aerocrine AB, Sweden

    Time frame: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)

  3. Change in Blood samples

    Cytokines (IL-8), DNA-damages

    Time frame: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)

  4. Change in nasal volume (using Acoustic rhinometry)

    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.

    Time frame: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)

  5. Change in biomarkers in Saliva Sample

    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.)

    Time frame: At baseline (0 hour), after exposure (5 hours), and the day after exposure (24 hours)

  6. Change in Subjective Symptoms

    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.

    Time frame: Every 30 minute during 5 hours of exposure

07

Study locations

1 site
  • Climate Chambers, Dept. Public Health, Aarhus University
    Aarhus, Central Region Denmark 8000, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04315740
Lead sponsor
University of Aarhus
Collaborators
University of Copenhagen, Aarhus University Hospital
Responsible party
Torben Sigsgaard (Professor, University of Aarhus) — Principal investigator
First posted
Mar 19, 2020
Start date
Apr 1, 2019
Primary completion
Dec 20, 2019
Completion
Dec 20, 2019
Last update
Nov 6, 2020

Study contacts

Karin R Laursen, MSc
principal investigator · Department of Public Health, Aarhus Universitet

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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