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This is a randomized controlled human exposure crossover study. Investigators aims to assess the acute effects of low-temperature exposure on cognitive function 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℃) and once to the 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 cognitive function tests and magnetic resonance imaging. Investigators plan to collect blood and urine samples.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low temperature (15℃) group | Experimental | Subjects in the exposure group will be exposed to low temperature (15℃) for about 2 hours in a chamber. |
|
| Moderate temperature (22℃) group | Experimental | Subjects in the 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 (15℃) group | Other | The exposure group will be exposed to low temperature (15℃) in a chamber for about 2 hours, resting during the whole period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Results of Stroop Tests | Investigators plan to measure the changes of cognitive function using Stroop Test. The time taken to complete the test could reflect cognitive function, and a shorter time means better cognitive function. | before exposure and immediately after the exposure session |
| Measure | Description | Time Frame |
|---|---|---|
| Results of simple reaction time | Investigators plan to measure the changes of cognitive function using visual memory test | before exposure and immediately after the exposure session |
| Activated brain regions demonstrating neural activity related to the high temperature exposure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in brain-derived neurotrophic factor (BDNF) concentrations |
Inclusion Criteria:
Exclusion Criteria:
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| 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 | 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 |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 14, 2024 | Oct 15, 2024 | 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℃) group | Other | The exposure group will be exposed to thermoneutral temperature (22℃) in a chamber for about 2 hours, resting during the whole period. |
|
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. The fractional amplitude of low frequency fluctuation (fALFF) would be extracted to reflect neural activity of brain regions. |
| 1 hour after exposure session |
| Activated brain regions demonstrating neural connectivity 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. The degree of centrality (DC) would be extracted to reflect neural connectivity of brain regions. | 1 hour after exposure session |
| Activated brain regions demonstrating neural synchronization 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. The regional homogeneity (ReHo) would be extracted to reflect neural synchronization of brain regions. | 1 hour after exposure session |
| Changes of skin temperature | The changes of wrist skin temperature will be measured | Skin temperature will be examined during the 2-hour exposure session (i.e., 1:00 P.M. to 3:00 P.M. on the day of the exposure session) |
Change in the concentrations of BDNF in blood. |
| 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session |
| Change in glial cell line-derived neurotrophic factor (GDNF) concentrations | Change in the concentrations of GDNF in blood. | 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session |
| Change in γ-aminobutyric acid (GABA) concentrations | Change in the concentrations of GABA in blood. | 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session |
| Change in Interleukin-1β (IL-1β) concentrations | Change in the concentrations of IL-1β in blood. | 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session |
| Change in Interferon-β (IFN-β) concentrations | Change in the concentrations of IFN-β in blood. | 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session |
| Change in glutathione (GSH) concentrations | Change in the concentrations of GSH in blood. | 1:00 P.M. on the day of the exposure session, 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. | before exposure and immediately 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 |