Clinical trial NCT05575752: Acute Health Effects of High Temperature Exposure
Official title: Acute Health Effects of High Temperature Exposure in Healthy Young Adults: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiovascular System
Respiratory System
Cognitive Function
Keywords: High Temperature
Randomized controlled trial
Cardiovascular effects
cognitive function
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

Detailed description: The investigators will conduct a randomized controlled human exposure crossover study among about 30 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes of pulse wave velocity measured by an arteriography device performing oscillometric measurement
timeFrame: Pulse wave velocity will be examined before exposure and immediately after the exposure session
measure: Changes of AIx@75 measured by an arteriography device performing oscillometric measurement
timeFrame: AIx@75 will be examined before exposure and immediately after the exposure session
measure: Changes of reflection magnitude measured by an arteriography device performing oscillometric measurement
timeFrame: Reflection magnitude will be examined before exposure and immediately after the exposure session
measure: Results of Stroop Tests
timeFrame: The tests will be conducted before exposure and immediately after the exposure session
measure: Changes of forced expiratory volume in the first second (FEV1)
timeFrame: The tests will be examined before exposure and half an hour after exposure
measure: Changes of forced vital capacity (FVC)
timeFrame: FVC will be examined before exposure and half an hour after exposure
measure: Changes of peak expiratory flow rate (PEF)
timeFrame: FVC will be examined before exposure and half an hour after exposure
measure: Changes of maximum expiratory flow rate at 25% vital capacity (MEF25)
timeFrame: MEF25 will be examined before exposure and half an hour after exposure
measure: Changes of maximum expiratory flow rate at 50% vital capacity (MEF50)
timeFrame: MEF50 will be examined before exposure and half an hour after exposure
measure: Changes of maximum expiratory flow rate at 75% vital capacity (MEF75)
timeFrame: MEF75 will be examined before exposure and half an hour after exposure
Secondary outcomes:
measure: Blood Pressure
timeFrame: Blood pressure will be examined before exposure and immediately after the exposure session
measure: Results of Schulte table Tests
timeFrame: The tests will be conducted before exposure and immediately after the exposure session
measure: Activated brain regions demonstrating neural activity related to the high temperature exposure
timeFrame: 1 hour after exposure session
measure: Activated brain regions demonstrating neural connectivity related to the high temperature exposure
timeFrame: 1 hour after exposure session
measure: Activated brain regions demonstrating neural synchronization related to the high temperature exposure
timeFrame: 1 hour after exposure session
measure: Changes of airway inflammation indicator fractional concentration of carbon monoxide (FeCO)
timeFrame: FeCO will be examined before exposure and half an hour after exposure
measure: Changes of airway inflammation indicator fractional exhaled nitric oxide (FeNO)
timeFrame: FeNO will be examined before exposure and half an hour after exposure
Other outcomes:
measure: Changes of the scores of thermal sensation questionnaires
timeFrame: before exposure and immediately after the exposure session
measure: Differences in RNA expression levels detected in serum transcriptomics between the two exposures
timeFrame: 1 hour after the exposure session
measure: Differences in protein levels detected in blood Clara cell protein (CC16) between the two exposures
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Differences in protein levels detected in blood chitinase-3-like protein 1 (YKL-40) between the two exposures
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Changes of heart rate variability (HRV) parameter RMSSD
timeFrame: 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.
measure: Changes of heart rate variability (HRV) parameter SDNN
timeFrame: 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.
measure: Changes of heart rate variability (HRV) parameter PNN50
timeFrame: 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.
measure: Differences in metabolic profiling detected in blood between the two exposures
timeFrame: 1 hour after the exposure session
measure: Differences in protein levels detected in blood between the two exposures
timeFrame: 1 hour after the exposure session
measure: Differences in DNA methylation levels detected in whole-blood between the two exposures
timeFrame: 1 hour after the exposure session
measure: Change in tumor necrosis factor-α (TNF-α) concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in C reactive protein (CRP) concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in oxidized low density lipoprotein (Ox-LDL) concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in malondialdehyde (MDA) concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in von Willebrand factor (vWF) concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in fibrinogen concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in endothelial nitric oxide synthase (eNOS) concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in endothelin-1 (ET-1) concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in blood glucose concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in insulin concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in low-density lipoprotein cholesterol (LDL) concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in total cholesterol (TC) concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in apolipoprotein B (ApoB) concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in matrix metallopeptidase 2 (MMP2) concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in matrix metallopeptidase 9 (MMP9) concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Changes of skin sebum level
timeFrame: 60 minutes and 120 minutes of exposure.
measure: Changes of facial secreted sebum composition
timeFrame: One hour after the exposure session
measure: Changes of the luminosity on the cheeks
timeFrame: before exposure and at 40 minutes after the end of exposure
measure: Changes of the pores on the cheeks
timeFrame: before exposure and at 40 minutes after the end of exposure
measure: Changes of subjective skin sensations
timeFrame: 30, 60, 90, and 120 minutes after the start of each exposure session
measure: Changes of stratum corneum protein levels
timeFrame: within 30 minutes after the end of exposure
measure: Differences in lipid metabolites levels detected in skin surface between the two exposures
timeFrame: Skin surface sebum was collected 5 minutes after exposure
measure: Change in total antioxidant capacity of collected stratum corneum
timeFrame: within 30 minutes after the end of exposure
measure: Change in kallikrein-5 concentrations of collected stratum corneum
timeFrame: within 30 minutes after the end of exposure
measure: Change in interleukin-1α concentrations of collected stratum corneum
timeFrame: within 30 minutes after the end of exposure
measure: Change in total protein concentrations of collected stratum corneum
timeFrame: within 30 minutes after the end of exposure
measure: Change in interleukin-1 receptor antagonist concentrations of collected stratum corneum
timeFrame: within 30 minutes after the end of exposure
measure: Differences in protein levels related to cardiovascular system and inflammation detected in blood between the two exposures
timeFrame: 1 hour after the exposure session
measure: Change in brain-derived neurotrophic factor (BDNF) concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in glial cell line-derived neurotrophic factor (GDNF) concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in Gamma-aminobutyric acid (GABA) concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in glutathione (GSH) concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in interferon (IFN) concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
Locations:
city: Shanghai
country: China
facility: Department of Environmental Health, School of Public Health, Fudan University
state: Shanghai
Study officials:
affiliation: Department of Environmental Health, School of Public Health, Fudan University
name: Haidong Kan, PhD
role: STUDY_DIRECTOR
References: