Acute Effects of Cold Exposure on Cardiovascular System

Acute Effects of Cold Exposure on Cardiovascular System and Potential Mechanism in Healthy Young Adults: A Randomized Controlled Study

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular System
• Intervention / Treatment: Other: Moderate temperature (22°C) group; Other: Low temperature (15°C) group

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Haidong Kan, PhD; Phone Number: +86-021-54237908; Email: kanh@fudan.edu.cn
• Study Contact Backup: Name: Renjie Chen, PhD; Phone Number: +86-021-54237908; Email: chenrenjie@fudan.edu.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Department of Environmental Health, School of Public Health, Fudan University
      • Contact: Haidong Kan, PhD; Phone Number: +86-021-54237908; Email: kanh@fudan.edu.cn
      • Contact: Renjie Chen, PhD; Phone Number: +86-021-54237908; Email: chenrenjie@fudan.edu.cn
      • Principal Investigator: Renjie Chen, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Moderate temperature (22°C) group; Subjects in exposure group will be exposed to moderate temperature (22°C) for about 2 hours in a chamber.	Other: Moderate temperature (22°C) group; The exposure group will be exposed to thermoneutral temperature (22°C) in a chamber for about 2 hours, resting during the whole periods.
Experimental: Low temperature (15°C) group; Subjects in exposure group will be exposed to low temperature (15°C) for about 2 hours in a chamber.	Other: Low temperature (15°C) group; The exposure group will be exposed to low temperature (15°C) in a chamber for about 2 hours, resting during the whole periods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
SDNN (standard deviation of NN intervals)	Investigators plan to measure heart rate variability (HRV) parameter SDNN	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.
SDANN (standard deviation of the averages of RR intervals)	Investigators plan to measure heart rate variability parameter SDANN	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.
rMSSD (root mean square of successive differences)	Investigators plan to measure heart rate variability (HRV) parameter rMSSD	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.
pNN50 (Percentage of differences between adjacent RR intervals greater than 50 ms)	Investigators plan to measure heart rate variability (HRV) parameter pNN50	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.
Frequency domain measures: low frequency (LF), high frequency (HF), and LF/HF ratio	Investigators plan to measure frequency domain parameters of heart rate variability (HRV)	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of scores of symptoms questionnaires	The changes of scores of respiratory and cardiovascular symptoms questionnaires both the total and each symptom specified	The questionnaires will be conducted before exposure and immediately after the exposure
Changes of skin temperature	The changes of wrist skin temperature will be measured	Skin temperature will be examined during the 2-hour exposure session

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	The questionnaires will be conducted before exposure and immediately after the exposure session
Differences in metabolic profiling detected in blood between the two exposures	The differential metabolic profiling in blood related to high temperature exposurewill be detected by maspectrometrybased non-targeted metabolomics.	1 hour after the exposure session
Differences in RNA expression levels detected in serum transcriptomics between the two exposures	Illumina-based transcriptomics is non-targeted. The study is to find the differentially expressed exosome RNA in serum after low temperature exposure	1 hour after the exposure session
Differences in DNA methylation levels detected in whole-blood between the two exposures	Genome-wide DNA methylation in whole-blood were detected. The study is to identify differential CpG loci after low temperature exposure	1 hour after the exposure session
Change in serum 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
Change in serum APOA1 concentrations	Change in the concentrations of APOA1 in blood will be measured.	1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
Change in serum APOB concentrations	Change in the concentrations of APOB in blood will be measured.	1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
Change in serum Cholesterol concentrations	Change in the concentrations of Cholesterol in blood will be measured.	1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
Change in serum Glucose concentrations	Change in the concentrations of Glucose in blood will be measured.	1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
Change in serum HDL concentrations	Change in the concentrations of HDL in blood will be measured.	1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
Change in serum Insulin concentrations	Change in the concentrations of Insulin in blood will be measured.	1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
Change in serum LDL concentrations	Change in the concentrations of LDL in blood will be measured.	1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
Change in serum LPa concentrations	Change in the concentrations of LPa in blood will be measured.	1:00 P.M. on the day of the exposure session, 1 hour after the exposure session
Change in serum TG concentrations	Change in the concentrations of TG in blood will be measured.	1:00 P.M. on the day of the exposure session, 1 hour after the exposure session

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Study Director: Haidong Kan, PhD, Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2024
• Primary Completion (Actual): November 16, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: October 18, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Cardiovascular system; Low temperature
• Other Study ID Numbers: IRB#2024-10-1167

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No