Acute Health Effects Due to Ultrafine Particles From Candles and Cooking

NCT04315740 | Completed DMC

• 1 other identifier: 191100
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Particle contamination; Indoor air; Acute health effects; RCT; Asthma

Outcome Measures

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

Secondary Outcomes (6)

• Change in Lung Function (FEV1 & FVC)

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

• Change in Fractional exhaled nitric oxide (FENO)

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

• Change in Blood samples

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

• Change in nasal volume (using Acoustic rhinometry)

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

• Change in biomarkers in Saliva Sample

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

Study Arms (3)

Clean Air

SHAM COMPARATOR

Just clean air - no exposure

Other: Clean Air

Cooking

EXPERIMENTAL

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

Candles

EXPERIMENTAL

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

Other: Particles from candles

Interventions

Particles from candles OTHER

Generating fine and ultrafine particles from lit candles

Candles

Particles from cooking OTHER

Generating fine and ultrafine particles from frying pork in an oven

Cooking

Clean Air OTHER

Nothing but clean air

Clean Air

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged 15-25
• Medically treated / physician diagnosed mild seasonal asthma
• Never smoker or ex-smoker ≥ 6 months
• Allergy \> 1 common allergy

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• University of Copenhagen: collaborator
• Aarhus University Hospital: collaborator

Study Sites (1)

Climate Chambers, Dept. Public Health, Aarhus University

Aarhus, Central Region Denmark, 8000, Denmark

Location

MeSH Terms

Conditions

Respiratory Insufficiency; Asthma

Interventions

Environment, Controlled

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Environment; Environment and Public Health

Study Officials

• Karin R Laursen, MSc

  Department of Public Health, Aarhus Universitet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A randomised double-blinded crossover study

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 19, 2020
• Study Start: April 1, 2019
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: November 6, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)