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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05575752
Other study ID # FDUEH-8
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 23, 2022
Est. completion date December 31, 2023

Study information

Verified date December 2022
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 aims to assess the acute effects of high temperature exposure and the underlying mechanisms.


Description:

The investigators will conduct a randomized controlled human exposure crossover study among about 40 healthy young adults in Shanghai, China. Each subject will be exposed twice: once to the high temperature (32℃) and once to moderate temperature (22℃) in a chamber for about 2 hours. During the exposure session, each subject will be requested to rest. Health examinations will be conducted immediately prior to exposure, during the period of exposure and after exposure. Health examinations include symptom questionnaire, blood pressure tests, cognitive function tests, magnetic resonance imaging, skin tests, spirometry, and Holter monitoring. Investigators plan to collect blood, urine and oropharyngeal swabs samples.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date December 31, 2023
Est. primary completion date November 19, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria: - Living in Shanghai during the study period; - Body mass index > 18.5 and = 28; - right-handed; - receiving or having received higher education; - with ability to read and understand Chinese smoothly. 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 due to the cardiovascular, cerebrovascular, respiratory, or neurological diseases; - Subjects with neurologic disorders, such as stroke, traumatic brain injury, epilepsy, and schizophrenia; - Abnormal spirometry (FEV1 and FVC = 75% of predicted and FEV1/FVC = 0.65); - Subjects with color vision disabilities.

Study Design


Intervention

Other:
high temperature (32?) group
The exposure group will be exposed to high temperature (32?) in a chamber for about 2 hours, resting during the whole periods.
moderate temperature (22?) group
The exposure group will be exposed to thermoneutral temperature (22?) in a chamber for about 2 hours, resting during the whole periods.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Differences in metabolic profiling detected in blood between the two exposures The differential metabolic profiling in blood related to high temperature exposure will be detected by mass spectrometry-based non-targeted metabolomics. 1 hour after the exposure session
Other Differences in protein levels detected in blood between the two exposures The differentially expressed proteins in blood related to high temperature exposure will be detected by non-targeted proteomics. 1 hour after the exposure session
Other Change in C reactive protein (CRP) concentrations Change in the concentrations of C reactive protein in blood. 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
Other Change in heat shock proteins concentrations Change in the concentrations of heat shock proteins in blood. 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
Other Changes of the scores of thermal sensation questionnaires Changes of scores of thermal sensation questionnaires which ranged from -5 to 5. Zero score refers to the thermal comfort sensation. Higher scores refer to more uncomfortable sensations of hot. Lower scores refer to more uncomfortable sensations of cold. 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
Other Changes of skin sebum secretion rate Evaluation of the differential sebum secretion rate between the two groups half an hour after the exposure session
Other Changes of facial secreted sebum composition Evaluation of the differential facial secreted sebum composition between the two groups half an hour after the exposure session
Primary Heart Rate Variability Parameters SDNN Investigators plan to measure standard deviation of NN intervals (SDNN) in millisecond. Volunteers will be asked to wear electrographic Holter monitors for 24 hours from 1:00 P.M. at the day of intervention to 1:00 P.M. at the next day.
Primary Results of Stroop Tests Investigators plan to measure the changes of cognitive function using Stroop Test. The tests will be conducted before exposure and immediately after the exposure session
Primary Results of schulte table Tests Investigators plan to measure the changes of cognitive function using schulte table. The tests will be conducted before exposure and immediately after the exposure session
Primary Activated brain regions demonstrating brain activity related to the high temperature exposure Investigators plan to measure brain activity associated with high temperature exposure by magnetic resonance imaging (MRI). Brain imaging data will be extracted from MRI data. 1 hour after exposure session
Secondary Changes of lung function indicators forced vital capacity (FVC) Investigators plan to measure the changes of forced vital capacity. FVC will be examined before exposure and half an hour after exposure
Secondary Changes of lung function indicators forced expiratory volume in 1 second (FEV1) Investigators plan to measure the changes of forced expiratory volume in 1 second. FEV1 will be examined before exposure and half an hour after exposure
Secondary Changes of the scores of cardiovascular symptoms questionnaires Changes of scores of cardiovascular symptoms questionnaires which ranged from 0 to 40. Higher scores of the cardiovascular symptoms questionnaires mean more severe cardiovascular symptoms. The cardiovascular symptoms questionnaires will be conducted before exposure and immediately after the exposure session
Secondary Blood Pressure The changes of systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be measured. Blood pressure will be examined before exposure and immediately after the exposure session
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