Pulmonary Function Clinical Trial
Official title:
Acute Health Effects of Ozone Exposure in Healthy Young Adults: a Randomized Controlled Study
Verified date | July 2021 |
Source | Fudan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized controlled human exposure crossover study. Investigators aim to investigate the acute health effects of ozone exposure in healthy young adults.
Status | Completed |
Enrollment | 32 |
Est. completion date | October 12, 2019 |
Est. primary completion date | December 9, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
China | Department of Environmental Health, School of Public Health, Fudan University | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Fudan University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | |
Other | Difference in ACTH concentrations between the two exposures | Difference in the serum concentrations of adrenocorticotropic hormone between ozone exposure and filtered air exposure | 2 hours after the completion of exposure. | |
Other | 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 | |
Other | 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. | |
Other | 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. | |
Other | 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. | |
Other | 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. | |
Other | 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. | |
Other | 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. | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Primary | 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 | |
Primary | 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 | |
Secondary | HRV | Heart rate variability | Holter monitoring will be performed continuously for 24 hours. |
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