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This is a randomized controlled human exposure crossover study. Investigators aim to investigate the acute health effects of ozone exposure in healthy young adults.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposure group | Experimental | Subjects in exposure group will be exposed to 200 ppb ozone for 2 hours in a chamber. |
|
| Control group | Sham Comparator | Subjects in control group will be exposed to 0 ppb ozone (clean air) for 2 hours in a chamber. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of FEV1 | Changes of forced expiratory volume in 1 second | FEV1 will be examined immediately prior to exposure, immediately after exposure, 2 hours after exposure and again the next morning |
| Changes of FVC | Changes of forced vital capacity | FVC will be examined immediately prior to exposure, immediately after exposure, 2 hours after exposure and again the next morning |
| Measure | Description | Time Frame |
|---|---|---|
| HRV | Heart rate variability | Holter monitoring will be performed continuously for 24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in CRF concentrations between the two exposures | Difference in the serum concentrations of corticotrophin releasing factor between ozone exposure and filtered air exposure | 2 hours after the completion of exposure. |
| Difference in ACTH concentrations between the two exposures |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haidong Kan, Ph.D | Department of Environmental Health, School of Public Health, Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Environmental Health, School of Public Health, Fudan University | Shanghai | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32299865 | Derived | Niu Y, Chen R, Wang C, Wang W, Jiang J, Wu W, Cai J, Zhao Z, Xu X, Kan H. Ozone exposure leads to changes in airway permeability, microbiota and metabolome: a randomised, double-blind, crossover trial. Eur Respir J. 2020 Sep 3;56(3):2000165. doi: 10.1183/13993003.00165-2020. Print 2020 Sep. No abstract available. |
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| 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. |
|
Difference in the serum concentrations of adrenocorticotropic hormone between ozone exposure and filtered air exposure |
| 2 hours after the completion of exposure. |
| Difference in cortisol concentrations between the two exposures | Difference in the serum concentrations of cortisol between ozone exposure and filtered air exposure | 2 hours after the completion of exposure |
| Difference in adrenaline concentrations between the two exposures | Difference in the serum concentrations of adrenaline between ozone exposure and filtered air exposure | 2 hours after the completion of exposure. |
| Difference in noradrenaline concentrations between the two exposures | Difference in the serum concentrations of noradrenaline between ozone exposure and filtered air exposure | 2 hours after the completion of exposure. |
| Change in the amount of skin moisture | 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. | Immediately before exposure, 0.5 hours after the completion of exposure, and next morning. |
| Change in L-values | Change in skin color indicated by L-values, which was measured by a skin colorimeter. | Immediately before exposure, 0.5 hours after the completion of exposure, and next morning. |
| Change in a-values | Change in skin color indicated by a-values, which was measured by a skin colorimeter. | Immediately before exposure, 0.5 hours after the completion of exposure, and next morning. |
| Change in b-values | Change in skin color indicated by b-values, which was measured by a skin colorimeter. | Immediately before exposure, 0.5 hours after the completion of exposure, and next morning. |
| Difference in alpha diversity of microbiota between the two exposures | Difference in alpha diversity of microbiota in nasal secretions between ozone exposure and filtered air exposure | Immediately after the completion of exposure |
| Change in CC16 concentrations | Change in the serum concentrations of club cell protein | Immediately before exposure, 2 hours after the completion of exposure, and next morning |
| Differences in metabolite levels detected in serum metabolomics between the two exposures | 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. | 2 hours after the completion of exposure |
| Differences in metabolite levels detected in airway metabolomics between the two exposures | 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. | 2 hours after the completion of exposure |
| Differences in metabolite levels detected in urine metabolomics between the two exposures | 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. | Immediately after the completion of exposure |
| Differences in RNA expression levels detected in transcriptomics between the two exposures | Illumina-based transcriptomics is non-targeted. The study is to find the differentially expressed RNA between ozone exposure and filtered air exposure. | 2 hours after the completion of exposure |
| Differences in protein levels detected in serum proteomics between the two exposures | 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. | 2 hours after the completion of exposure |