Clinical trial NCT06076629: Acute Health Effects of Low Temperature Exposure
Official title: Acute Health Effects of Low Temperature Exposure in Healthy Young Adults: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiovascular System
Respiratory System
Cognitive Function
Keywords: Low temperature
Randomized controlled trial
Cardiopulmonary effects
Cognitive function
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 50
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 low temperature exposure and the underlying mechanisms.

Detailed description: 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.

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 the 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 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: Heart Rate Variability Parameters
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: Blood Pressure
timeFrame: Blood pressure will be examined before exposure and immediately after the exposure session
measure: Forced vital capacity
timeFrame: Lung function will be examined before exposure and half an hour after the exposure session
measure: Forced expiratory volume in one second
timeFrame: Lung function will be examined before exposure and half an hour after the exposure session
measure: Maximal mid-expiratory flow
timeFrame: Lung function will be examined before exposure and half an hour after the exposure session
measure: Results of Stroop Tests
timeFrame: The tests will be conducted before exposure and immediately after the exposure session
Secondary outcomes:
measure: Changes of skin temperature
timeFrame: Skin temperature will be examined from 1:00 P.M. to 4:30 P.M. at the day of intervention
measure: Results of simple reaction time
timeFrame: Simple reaction time will be examined before exposure and immediately after the exposure session
measure: Results of visual memory
timeFrame: Visual memory will be examined before exposure and immediately after the exposure session
measure: Activated brain regions demonstrating brain activity related to the low temperature exposure
timeFrame: MRI will be examined 1 hour after the exposure session
measure: Changes in cerebral hemodynamics demonstrating brain activity related to the low temperature exposure
timeFrame: fNIRS will be examined before exposure and immediately after the exposure session
Other outcomes:
measure: Differences in metabolites detected in blood between the two exposures
timeFrame: Blood will be collected 1 hour after the exposure session
measure: Differences in protein levels detected in blood between the two exposures
timeFrame: Blood will be collected 1 hour after the exposure session
measure: Differences in DNA methylation levels detected in whole-blood between the two exposures
timeFrame: Blood will be collected 1 hour after the exposure session
measure: Changes of the scores of thermal sensation questionnaires
timeFrame: The questionnaires will be conducted before exposure and immediately after the exposure session
measure: Changes of scores of symptoms questionnaires
timeFrame: The questionnaires will be conducted before exposure and immediately after the exposure session
measure: Change in C reactive protein (CRP) concentrations
timeFrame: Blood will be collected 1 hour after the exposure session
measure: Changes of facial secreted sebum composition
timeFrame: Facial sample will be collected half an 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: