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Completed

NCT Number: NCT03697174

Acute Health Effects of Ozone Exposure

This is a randomized controlled human exposure crossover study. Investigators aim to investigate the acute health effects of ozone exposure in healthy young adults.

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Environmental Health, School of Public Health, Fudan University

Shanghai, 200032, China

About this study

The investigators will conduct a randomized controlled human exposure crossover study among 32 healthy young adults in Shanghai, China. Each subject will be exposed twice: once to clean air and once to 200 ppb ozone in a chamber for 2 hours. During the 2-hour exposure, each subject will be requested to alternate 20 minutes of rest and 10 minutes of exercise on a treadmill. The exercise workload will be adjusted to achieve the targeted ventilation of 25 ~ 27 L/min(approximately equal to 15 ~ 18L/min/m2 body surface area). Ozone will be generated by a silent electric discharge method (HTU-500, AZCO Industries Ltd., Canada) and introduced into the chamber. The temperature and relative humidity in the chamber will be maintained at 22±1℃ and 55%±5%, respectively. Health examinations will be conducted immediately prior to exposure, immediately after exposure, 2 hours after exposure and again the next morning. Health examinations include symptom questionnaire, skin tests, spirometry, and Holter monitoring. We plan to collect blood, buccal, urine, nasal secretion, saliva, exhaled breath condensate, sebum, and D-squame samples.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Living in Shanghai during study period;
  • Ability to complete the exercise to achieve the ventilation of 15 to 18 L/min/m2 body surface area;
  • Body mass index >18.5 and ≤30.0 (30 is the lower limit for class 2 obesity for Chinese).

Exclusion criteria

  • Smoking and alcohol abuse;
  • Current drug and dietary supplements intake;
  • Subjects with allergic diseases, such as allergic rhinitis, allergic asthma, and atopy;
  • Subjects with cardiovascular diseases, such as congenital heart disease, pulmonary heart disease, and hypertension;
  • Subjects with respiratory diseases, such as asthma, chronic bronchitis, and chronic obstructive pulmonary disease;
  • Subjects with chronic diseases, such as diabetes, chronic hepatitis, and kidney disease;
  • Subjects who have a history of major surgery;
  • Abnormal spirometry (FEV1 and FVC ≤ 75% of predicted and FEV1/FVC ≤ 0.65);
  • Abnormal baseline 12-lead resting electrocardiogram;
  • Abnormal blood index, such as cell counting, blood lipids, and glutamic-pyruvic transaminase (GPT).

Treatment and study plan

200 ppb ozone group

Other

The exposure group will be exposed to 200 ppb ozone in a chamber for 2 hours while alternating 20-min rest and 10-min exercise periods. The exercise workload will be adjusted to achieve the targeted ventilation of 25 ~ 27 L/min(approximately equal to 15 ~ 18L/min/m2 body surface area). The temperature and relative humidity in the chamber will be maintained at 22±1℃ and 55%±5%, respectively.

0 ppb ozone group

Other

The control group will be exposed to 0 ppb ozone in a chamber for 2 hours while alternating 20-min rest and 10-min exercise periods. The exercise workload will be adjusted to achieve the targeted ventilation of 25 ~ 27 L/min(approximately equal to 15 ~ 18L/min/m2 body surface area). The temperature and relative humidity in the chamber will be maintained at 22±1℃ and 55%±5%, respectively.

Primary outcomes

  1. Changes of FEV1

    Time frame: FEV1 will be examined immediately prior to exposure, immediately after exposure, 2 hours after exposure and again the next morning

    Changes of forced expiratory volume in 1 second

  2. Changes of FVC

    Time frame: FVC will be examined immediately prior to exposure, immediately after exposure, 2 hours after exposure and again the next morning

    Changes of forced vital capacity

Secondary outcomes

  1. HRV

    Time frame: Holter monitoring will be performed continuously for 24 hours.

    Heart rate variability

Other outcomes

  1. Difference in CRF concentrations between the two exposures

    Time frame: 2 hours after the completion of exposure.

    Difference in the serum concentrations of corticotrophin releasing factor between ozone exposure and filtered air exposure

  2. Difference in ACTH concentrations between the two exposures

    Time frame: 2 hours after the completion of exposure.

    Difference in the serum concentrations of adrenocorticotropic hormone between ozone exposure and filtered air exposure

  3. Difference in cortisol concentrations between the two exposures

    Time frame: 2 hours after the completion of exposure

    Difference in the serum concentrations of cortisol between ozone exposure and filtered air exposure

  4. Difference in adrenaline concentrations between the two exposures

    Time frame: 2 hours after the completion of exposure.

    Difference in the serum concentrations of adrenaline between ozone exposure and filtered air exposure

  5. Difference in noradrenaline concentrations between the two exposures

    Time frame: 2 hours after the completion of exposure.

    Difference in the serum concentrations of noradrenaline between ozone exposure and filtered air exposure

  6. Change in the amount of skin moisture

    Time frame: Immediately before exposure, 0.5 hours after the completion of exposure, and next morning.

    Change in the amount of skin moisture, which was measure by a moisture meter. The number on the meter indicates how hydrated (or dehydrated) your skin is.

  7. Change in L-values

    Time frame: Immediately before exposure, 0.5 hours after the completion of exposure, and next morning.

    Change in skin color indicated by L-values, which was measured by a skin colorimeter.

  8. Change in a-values

    Time frame: Immediately before exposure, 0.5 hours after the completion of exposure, and next morning.

    Change in skin color indicated by a-values, which was measured by a skin colorimeter.

  9. Change in b-values

    Time frame: Immediately before exposure, 0.5 hours after the completion of exposure, and next morning.

    Change in skin color indicated by b-values, which was measured by a skin colorimeter.

  10. Difference in alpha diversity of microbiota between the two exposures

    Time frame: Immediately after the completion of exposure

    Difference in alpha diversity of microbiota in nasal secretions between ozone exposure and filtered air exposure

  11. Change in CC16 concentrations

    Time frame: Immediately before exposure, 2 hours after the completion of exposure, and next morning

    Change in the serum concentrations of club cell protein

  12. Differences in metabolite levels detected in serum metabolomics between the two exposures

    Time frame: 2 hours after the completion of exposure

    Mass spectrometry-based serum metabolomics is non-targeted.The study is to find the differential metabolites in serum between ozone exposure and filtered air exposure.

  13. Differences in metabolite levels detected in airway metabolomics between the two exposures

    Time frame: 2 hours after the completion of exposure

    Mass spectrometry-based metabolomics in exhaled breath condensate is non-targeted.The study is to find the differential metabolites in airway between ozone exposure and filtered air exposure.

  14. Differences in metabolite levels detected in urine metabolomics between the two exposures

    Time frame: Immediately after the completion of exposure

    Mass spectrometry-based urine metabolomics is non-targeted.The study is to find the differential metabolites in urine between ozone exposure and filtered air exposure.

  15. Differences in RNA expression levels detected in transcriptomics between the two exposures

    Time frame: 2 hours after the completion of exposure

    Illumina-based transcriptomics is non-targeted. The study is to find the differentially expressed RNA between ozone exposure and filtered air exposure.

  16. Differences in protein levels detected in serum proteomics between the two exposures

    Time frame: 2 hours after the completion of exposure

    Mass spectrometry-based proteomics in serum is non-targeted. The study is to find the differentially expressed proteins in serum between ozone exposure and filtered air exposure.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Acute Health Effects of Ozone Exposure in Healthy Young Adults: a Randomized Controlled Study

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Oct 5, 2018
Registry last updated
Jul 22, 2021

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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