Clinical trial NCT06652932: Acute Effects of Low Temperature Exposure on Respiratory System
Official title: Acute Effects of Low Temperature Exposure on Respiratory Health in Healthy Young Adults: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Function
Keywords: Low temperature
Randomized controlled trial
Lung function
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 40
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 on respiratory health and the underlying mechanisms.

Detailed description: 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 lung function tests and exhaled breath test. Investigators plan to collect blood, pharyngeal secretion, exhaled breath condensate and urine 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 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 forced expiratory volume in the first second (FEV1)
timeFrame: The tests will be conducted at 12:30 A.M. (half an hour before exposure) and 3:30 P.M. (half an hour after the exposure)
measure: Changes of forced vital capacity (FVC)
timeFrame: FVC will be examined at 12:30 A.M. (half an hour before exposure) and 3:30 P.M. (half an hour after the exposure)
measure: Changes of peak expiratory flow rate (PEF)
timeFrame: FVC will be examined at 12:30 A.M. (half an hour before exposure) and 3:30 P.M. (half an hour after the exposure)
measure: Changes of maximum expiratory flow rate at 25% vital capacity (MEF25)
timeFrame: MEF25 will be examined at 12:30 A.M. (half an hour before exposure) and 3:30 P.M. (half an hour after the exposure)
measure: Changes of maximum expiratory flow rate at 50% vital capacity (MEF50)
timeFrame: MEF50 will be examined at 12:30 A.M. (half an hour before exposure) and 3:30 P.M. (half an hour after the exposure)
measure: Changes of maximum expiratory flow rate at 75% vital capacity (MEF75)
timeFrame: MEF75 will be examined at 12:30 A.M. (half an hour before exposure) and 3:30 P.M. (half an hour after exposure)
Secondary outcomes:
measure: Changes of fractional exhaled nitric oxide (FeNO)
timeFrame: FeNO will be examined half an hour before exposure and half an hour after exposure
measure: Changes of fractional concentration of carbon monoxide (FeCO)
timeFrame: FeCO will be examined at 12:30 A.M. (half an hour before exposure) and 3:30 P.M. (half an hour after the exposure)
measure: Changes of skin temperature
timeFrame: Wrist skin temperature will be measured at 1:00 P.M. to 3:00 P.M. on the day of the exposure session
Other outcomes:
measure: Differences in protein levels detected in blood Clara cell protein (CC16) between the two exposures
timeFrame: CC16 will be examined at 1:00 P.M. and 4:00 P.M. (one hour after the exposure) on the day of the exposure session
measure: Differences in protein levels detected in blood chitinase-3-like protein 1 (YKL-40) between the two exposures
timeFrame: YKL-40 will be examined at 1:00 P.M. and 4:00 P.M. (one hour after exposure) on the day of the exposure session
measure: Differences in protein levels detected in blood Surfactant Protein-D (SP-D) between the two exposures
timeFrame: SP-D will be examined at 1:00 P.M. and 4:00 P.M. (one hour after exposure) on the day of the exposure session
measure: Differences in respiratory microbiota detected in pharyngeal secretion between the two exposures
timeFrame: Respiratory microbiota will be detected at 3:30 A.M. (half an hour after exposure) on the day of the exposure session
measure: Differences in metabolic profiling detected in exhaled breath condensate between the two exposures
timeFrame: Metabolic profiling in exhaled breath condensate will be detected at 4:00 P.M. (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: Fudan University
name: Haidong Kan, PhD
role: STUDY_DIRECTOR
References: