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This is a randomized controlled human exposure crossover study. Investigators aim to assess the acute effects of low temperature exposure on cardiovascular system and the underlying mechanisms.
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 low temperature (15°C) and once to the moderate temperature (22°C) in a chamber for about 2 hours. During the exposure session, each subject will be requested to rest. Health examinations will be conducted at baseline immediately prior to exposure, during the period of exposure, and after exposure. Health examinations include blood pressure tests and Holter monitoring. Investigators plan to collect blood and urine samples.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low temperature (15°C) group | Experimental | Subjects in exposure group will be exposed to low temperature (15°C) for about 2 hours in a chamber. |
|
| Moderate temperature (22°C) group | Experimental | Subjects in exposure group will be exposed to moderate temperature (22°C) for about 2 hours in a chamber. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low temperature (15°C) group | Other | The exposure group will be exposed to low temperature (15°C) in a chamber for about 2 hours, resting during the whole periods. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| SDNN (standard deviation of NN intervals) | Investigators plan to measure heart rate variability (HRV) parameter SDNN | 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. |
| SDANN (standard deviation of the averages of RR intervals) | Investigators plan to measure heart rate variability parameter SDANN | 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. |
| rMSSD (root mean square of successive differences) | Investigators plan to measure heart rate variability (HRV) parameter rMSSD | 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. |
| pNN50 (Percentage of differences between adjacent RR intervals greater than 50 ms) | Investigators plan to measure heart rate variability (HRV) parameter pNN50 | 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. |
| Frequency domain measures: low frequency (LF), high frequency (HF), and LF/HF ratio | Investigators plan to measure frequency domain parameters of heart rate variability (HRV) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of scores of symptoms questionnaires | The changes of scores of respiratory and cardiovascular symptoms questionnaires both the total and each symptom specified | The questionnaires will be conducted before exposure and immediately after the exposure |
| Changes of skin temperature |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in metabolic profiling detected in blood between the two exposures | The differential metabolic profiling in blood related to high temperature exposurewill be detected by maspectrometrybased non-targeted metabolomics. | 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 | |
|---|---|---|---|---|
| Renjie Chen, PhD | Contact | +86-021-54237908 | chenrenjie@fudan.edu.cn | |
| Haidong Kan, PhD | Contact | +86-021-54237908 | kanh@fudan.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Haidong Kan, PhD | Fudan University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Environmental Health, School of Public Health, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 14, 2024 | Oct 15, 2024 | Prot_SAP_000.pdf |
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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°C) group | Other | The exposure group will be exposed to thermoneutral temperature (22°C) in a chamber for about 2 hours, resting during the whole periods. |
|
| 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. |
The changes of wrist skin temperature will be measured |
| Skin temperature will be examined during the 2-hour exposure session |
The differentially expressed proteins in blood related to high temperature exposure will be detected by non-targeted proteomics. |
| 1 hour after the exposure session |
| Differences in RNA expression levels detected in serum transcriptomics between the two exposures | Illumina-based transcriptomics is non-targeted. The study is to find the differentially expressed exosome RNA in serum after low temperature exposure | 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 | 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 |
| Change in serum 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 |
| Change in serum APOA1 concentrations | Change in the concentrations of APOA1 in blood will be measured. | 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session |
| Change in serum APOB concentrations | Change in the concentrations of APOB in blood will be measured. | 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session |
| Change in serum Cholesterol concentrations | Change in the concentrations of Cholesterol in blood will be measured. | 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session |
| Change in serum Glucose concentrations | Change in the concentrations of Glucose in blood will be measured. | 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session |
| Change in serum HDL concentrations | Change in the concentrations of HDL in blood will be measured. | 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session |
| Change in serum Insulin concentrations | Change in the concentrations of Insulin in blood will be measured. | 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session |
| Change in serum LDL concentrations | Change in the concentrations of LDL in blood will be measured. | 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session |
| Change in serum LPa concentrations | Change in the concentrations of LPa in blood will be measured. | 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session |
| Change in serum TG concentrations | Change in the concentrations of TG in blood will be measured. | 1:00 P.M. on the day of the exposure session, 1 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 |