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NCT Number: NCT06652425

Acute Effects of Cold Exposure on Cardiovascular System

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.

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low temperature (15°C) group

Other

The exposure group will be exposed to low temperature (15°C) in a chamber for about 2 hours, resting during the whole periods.

Moderate temperature (22°C) group

Other

The exposure group will be exposed to thermoneutral temperature (22°C) in a chamber for about 2 hours, resting during the whole periods.

Primary outcomes

  1. Blood Pressure

    Time frame: Blood pressure will be examined before exposure and immediately after the exposure session

    The changes of systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be measured.

  2. SDNN (standard deviation of NN intervals)

    Time frame: 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.

    Investigators plan to measure heart rate variability (HRV) parameter SDNN

  3. SDANN (standard deviation of the averages of RR intervals)

    Time frame: 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.

    Investigators plan to measure heart rate variability parameter SDANN

  4. rMSSD (root mean square of successive differences)

    Time frame: 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.

    Investigators plan to measure heart rate variability (HRV) parameter rMSSD

  5. pNN50 (Percentage of differences between adjacent RR intervals greater than 50 ms)

    Time frame: 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.

    Investigators plan to measure heart rate variability (HRV) parameter pNN50

  6. Frequency domain measures: low frequency (LF), high frequency (HF), and LF/HF ratio

    Time frame: 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.

    Investigators plan to measure frequency domain parameters of heart rate variability (HRV)

Secondary outcomes

  1. Changes of scores of symptoms questionnaires

    Time frame: The questionnaires will be conducted before exposure and immediately after the exposure

    The changes of scores of respiratory and cardiovascular symptoms questionnaires both the total and each symptom specified

  2. Changes of skin temperature

    Time frame: Skin temperature will be examined during the 2-hour exposure session

    The changes of wrist skin temperature will be measured

Other outcomes

  1. Differences in metabolic profiling detected in blood between the two exposures

    Time frame: 1 hour after the exposure session

    The differential metabolic profiling in blood related to high temperature exposurewill be detected by maspectrometrybased non-targeted metabolomics.

  2. Differences in protein levels detected in blood between the two exposures

    Time frame: 1 hour after the exposure session

    The differentially expressed proteins in blood related to high temperature exposure will be detected by non-targeted proteomics.

  3. Differences in RNA expression levels detected in serum transcriptomics between the two exposures

    Time frame: 1 hour after the exposure session

    Illumina-based transcriptomics is non-targeted. The study is to find the differentially expressed exosome RNA in serum after low temperature exposure

  4. Differences in DNA methylation levels detected in whole-blood between the two exposures

    Time frame: 1 hour after the exposure session

    Genome-wide DNA methylation in whole-blood were detected. The study is to identify differential CpG loci after low temperature exposure

  5. Changes of the scores of thermal sensation questionnaires

    Time frame: The questionnaires will be conducted before exposure and immediately after the exposure session

    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.

  6. Change in serum CRP concentrations

    Time frame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session

    Change in the concentrations of C reactive protein in blood.

  7. Change in serum APOA1 concentrations

    Time frame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session

    Change in the concentrations of APOA1 in blood will be measured.

  8. Change in serum APOB concentrations

    Time frame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session

    Change in the concentrations of APOB in blood will be measured.

  9. Change in serum Cholesterol concentrations

    Time frame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session

    Change in the concentrations of Cholesterol in blood will be measured.

  10. Change in serum Glucose concentrations

    Time frame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session

    Change in the concentrations of Glucose in blood will be measured.

  11. Change in serum HDL concentrations

    Time frame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session

    Change in the concentrations of HDL in blood will be measured.

  12. Change in serum Insulin concentrations

    Time frame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session

    Change in the concentrations of Insulin in blood will be measured.

  13. Change in serum LDL concentrations

    Time frame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session

    Change in the concentrations of LDL in blood will be measured.

  14. Change in serum LPa concentrations

    Time frame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session

    Change in the concentrations of LPa in blood will be measured.

  15. Change in serum TG concentrations

    Time frame: 1:00 P.M. on the day of the exposure session, 1 hour after the exposure session

    Change in the concentrations of TG in blood will be measured.

Study contacts

Contact information is provided by the study sponsor or research team.

Haidong Kan, PhD

CONTACT

[email protected]

+86-021-54237908

Renjie Chen, PhD

CONTACT

[email protected]

+86-021-54237908

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Oct 22, 2024
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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