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This is a randomized controlled human exposure crossover study. Investigators aims to assess the acute effects of low temperature exposure and the underlying mechanisms.
The investigators will conduct a randomized controlled human exposure crossover study among about 50 healthy young adults in Shanghai, China. Each subject will be exposed twice: once to the low temperature (16#) and once to the moderate temperature (22#) in a chamber for about 2-2.5 hours. During the exposure session, each subject will be requested to rest. Health examinations will be conducted immediately prior to exposure (within 1 hour before the exposure session), during the period of exposure, and after exposure (within 2 hours after the exposure session). Health examinations include spirometry, Holter monitoring, blood pressure tests, cognitive function tests, symptom questionnaires, and magnetic resonance imaging. Investigators plan to collect blood, urine, exhaled breath condensate, and oropharyngeal swabs samples.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low temperature (16#) group | Experimental | Subjects in exposure group will be exposed to low temperature (16#) for about 2 hours in a chamber. |
|
| Moderate temperature (22#) group | Sham Comparator | Subjects in exposure group will be exposed to moderate temperature (22#) for about 2 hours in a chamber. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low temperature (16#) group | Other | The exposure group will be exposed to low temperature (16#) in a chamber for about 2 hours, resting during the whole periods. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate Variability Parameters | Investigators plan to measure heart rate variability (HRV) parameters (e.g., SDNN, PNN50, LF, HF) | 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. |
| 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 |
| Forced vital capacity | Investigators plan to measure forced vital capacity (FVC) by spirometry | Lung function will be examined before exposure and half an hour after the exposure session |
| Forced expiratory volume in one second | Investigators plan to measure forced expiratory volume in one second (FEV1) by spirometry. | Lung function will be examined before exposure and half an hour after the exposure session |
| Maximal mid-expiratory flow | Investigators plan to measure maximal mid-expiratory flow (MMEF) by spirometry. | Lung function will be examined before exposure and half an hour after the exposure session |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of skin temperature | The changes of wrist skin temperature will be measured | Skin temperature will be examined from 1:00 P.M. to 4:30 P.M. at the day of intervention |
| Results of simple reaction time |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in metabolites detected in blood between the two exposures | The differentially expressed metabolites in blood related to low temperature exposure will be detected by maspectrometry-based non-targeted metabolomics. | Blood will be collected 1 hour after the exposure session |
| Differences in protein levels detected in blood between the two exposures |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haidong Kan, PhD | Contact | +86-021-54237908 | kanh@fudan.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Haidong Kan, PhD | Department of Environmental Health, School of Public Health, Fudan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Environmental Health, School of Public Health, Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D003080 | Cold Temperature |
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D013696 | Temperature |
| D013816 | Thermodynamics |
| D055585 | Physical Phenomena |
| D014887 | Weather |
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| Moderate temperature (22#) group | Other | The exposure group will be exposed to thermoneutral temperature (22#) in a chamber for about 2 hours, resting during the whole periods. |
|
Investigators plan to measure the changes of cognitive function using visual simple reaction time test.
| Simple reaction time will be examined before exposure and immediately after the exposure session |
| Results of visual memory | Investigators plan to measure the changes of cognitive function using visual memory test. Every level, a number of tiles will flash white. The participants will be required to memorize them, and pick them again after the tiles are reset. Higher levels refer to better visual memory. | Visual memory will be examined before exposure and immediately after the exposure session |
| Activated brain regions demonstrating brain activity related to the low temperature exposure | Investigators plan to conduct magnetic resonance imaging (MRI) after exposure. The MRI data will be processed through Data Processing and Analysis for Brain Imaging (DPABI) sofrware to obtain brain activity parameters, such as fractional amplitude of low-frequency fluctuation (fALFF). Brain regions that change after exposure between the two groups would be further idenfitied. | MRI will be examined 1 hour after the exposure session |
| Changes in cerebral hemodynamics demonstrating brain activity related to the low temperature exposure | Investigators plan to conduct functional near-infrared spectroscopy (fNIRS) to measure the changes in oxygenated hemoglobin and deoxygenated hemoglobin after exposure. Matlab would be applied to process data and evaluate the changes in cerebral hemodynamics associated with low temperature exposure | fNIRS will be examined before exposure and immediately after the exposure session |
The differentially expressed proteins in blood related to low temperature exposure will be detected by non-targeted proteomics. |
| Blood will be collected 1 hour after the exposure session |
| Differences in DNA methylation levels detected in whole-blood between the two exposures | Genome-wide DNA methylation in whole-blood were detected. The study is to identify differential CpG loci after low temperature exposure | Blood will be collected 1 hour after the exposure session |
| 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. | The questionnaires will be conducted before exposure and immediately after the exposure session |
| Changes of scores of symptoms questionnaires | Changes of scores of respiratory and cardiovascular symptoms questionnaires which ranged from 0 to 5. Zero score refers to no symptoms, and higher scores refer to more severe symptoms. | The questionnaires will be conducted before exposure and immediately after the exposure session |
| Change in C reactive protein (CRP) concentrations | Change in the concentrations of C reactive protein in blood. | Blood will be collected 1 hour after the exposure session |
| Changes of facial secreted sebum composition | Investigators plan to collect facial secreted sebum composition using Sebutape. The differential facial secreted sebum composition between the two groups would be further evaluated. | Facial sample will be collected half an hour after the exposure session |
| D001272 |
| Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |
| D003710 | Demography |
| D011154 | Population Characteristics |