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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03697174
Other study ID # FDUEH-5
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 7, 2018
Est. completion date October 12, 2019

Study information

Verified date July 2021
Source Fudan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

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).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
200 ppb ozone group
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
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.

Locations

Country Name City State
China Department of Environmental Health, School of Public Health, Fudan University Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

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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