Cognitive Function Clinical Trial
Official title:
Acute Health Effects of High Temperature Exposure in Healthy Young Adults: a Randomized Controlled Study
Verified date | December 2022 |
Source | Fudan University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized controlled human exposure crossover study. Investigators aims to assess the acute effects of high temperature exposure and the underlying mechanisms.
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. |
Country | Name | City | State |
---|---|---|---|
China | Department of Environmental Health, School of Public Health, Fudan University | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Fudan University |
China,
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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