Department of Environmental Health, School of Public Health, Fudan University
Shanghai, 200032, China
NCT Number: NCT03697174
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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Notify Me18 year–30 year
All sexes
Interventional
Not applicable
Shanghai, 200032, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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
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
Time frame: Holter monitoring will be performed continuously for 24 hours.
Heart rate variability
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
Time frame: 2 hours after the completion of exposure.
Difference in the serum concentrations of adrenocorticotropic hormone between ozone exposure and filtered air exposure
Time frame: 2 hours after the completion of exposure
Difference in the serum concentrations of cortisol between ozone exposure and filtered air exposure
Time frame: 2 hours after the completion of exposure.
Difference in the serum concentrations of adrenaline between ozone exposure and filtered air exposure
Time frame: 2 hours after the completion of exposure.
Difference in the serum concentrations of noradrenaline between ozone exposure and filtered air exposure
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.
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.
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.
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.
Time frame: Immediately after the completion of exposure
Difference in alpha diversity of microbiota in nasal secretions between ozone exposure and filtered air exposure
Time frame: Immediately before exposure, 2 hours after the completion of exposure, and next morning
Change in the serum concentrations of club cell protein
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.
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.
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.
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.
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.
Fudan University
Other
Acute Health Effects of Ozone Exposure in Healthy Young Adults: a Randomized Controlled Study
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