Clinical trial NCT06652425: Acute Effects of Cold Exposure on Cardiovascular System
Official title: Acute Effects of Cold Exposure on Cardiovascular System and Potential Mechanism in Healthy Young Adults: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular System
Keywords: Low temperature
Randomized controlled trial
Cardiovascular system
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 aim to assess the acute effects of low temperature exposure on cardiovascular system 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°C) and once to the moderate temperature (22°C) in a chamber for about 2 hours. During the exposure session, each subject will be requested to rest. Health examinations will be conducted at baseline immediately prior to exposure, during the period of exposure, and after exposure. Health examinations include blood pressure tests and Holter monitoring. Investigators plan to collect blood 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 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: Blood Pressure
timeFrame: Blood pressure will be examined before exposure and immediately after the exposure session
measure: SDNN (standard deviation of NN intervals)
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: SDANN (standard deviation of the averages of RR intervals)
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: rMSSD (root mean square of successive differences)
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: pNN50 (Percentage of differences between adjacent RR intervals greater than 50 ms)
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: Frequency domain measures: low frequency (LF), high frequency (HF), and LF/HF ratio
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.
Secondary outcomes:
measure: Changes of scores of symptoms questionnaires
timeFrame: The questionnaires will be conducted before exposure and immediately after the exposure
measure: Changes of skin temperature
timeFrame: Skin temperature will be examined during the 2-hour exposure session
Other outcomes:
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 RNA expression levels detected in serum transcriptomics 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: Changes of the scores of thermal sensation questionnaires
timeFrame: The questionnaires will be conducted before exposure and immediately after the exposure session
measure: Change in serum CRP concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in serum APOA1 concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in serum APOB concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in serum Cholesterol concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in serum Glucose concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in serum HDL concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in serum Insulin concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in serum LDL concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in serum LPa concentrations
timeFrame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
measure: Change in serum TG 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: Fudan University
name: Haidong Kan, PhD
role: STUDY_DIRECTOR
References: