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Completed

NCT Number: NCT04315740

Acute Health Effects Due to Ultrafine Particles From Candles and Cooking

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.

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Key information

Conditions

Candle Burning Asthma Bronchial Diseases Cooking DNA Damage Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Lung Function Decreased Respiration Disorders Respiratory Hypersensitivity Respiratory Insufficiency Respiratory Tract Diseases Subjective Health

Age range

15 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Climate Chambers, Dept. Public Health, Aarhus University

Aarhus, Central Region Denmark, 8000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Particles from candles

Other

Generating fine and ultrafine particles from lit candles

Particles from cooking

Other

Generating fine and ultrafine particles from frying pork in an oven

Clean air

Other

Nothing but clean air

Primary outcomes

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

    Time frame: 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 outcomes

  1. Change in Lung Function (FEV1 & FVC)

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

    Spirometry

  2. Change in Fractional exhaled nitric oxide (FENO)

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aarhus University Hospital
  • University of Copenhagen

Registry information

Official study title

THE ULTRAFINE PROJECT - A Study of Acute Health Effects of Exposure to Particles Generated by Candles and Cooking

Acronym: Ultrafine

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 19, 2020
Registry last updated
Nov 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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