Acute Effects of Cold Exposure on Cardiovascular System
ConditionCardiovascular System
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorFudan University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Living in Shanghai during the study period;
Body mass index > 18.5 and ≤ 28;
Right-handed;
Receiving or having received higher education;
Disqualifiers
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;
Trial design
Design model
Crossover
Treatments tested in this trial
Low temperature (15°C) group
Other interventionThe 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 interventionThe exposure group will be exposed to thermoneutral temperature (22°C) in a chamber for about 2 hours, resting during the whole periods.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Low temperature (15°C) groupExperimental treatment 1 intervention
Group B: Moderate temperature (22°C) groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Blood Pressure
The changes of systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be measured.
Time frame
Blood pressure will be examined before exposure and immediately after the exposure session2
SDNN (standard deviation of NN intervals)
Investigators plan to measure heart rate variability (HRV) parameter SDNN
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.3
SDANN (standard deviation of the averages of RR intervals)
Investigators plan to measure heart rate variability parameter SDANN
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.4
rMSSD (root mean square of successive differences)
Investigators plan to measure heart rate variability (HRV) parameter rMSSD
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.Secondary outcomes
1
Changes of scores of symptoms questionnaires
The changes of scores of respiratory and cardiovascular symptoms questionnaires both the total and each symptom specified
Time frame
The questionnaires will be conducted before exposure and immediately after the exposure2
Changes of skin temperature
The changes of wrist skin temperature will be measured
Time frame
Skin temperature will be examined during the 2-hour exposure sessionOther outcomes
1
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.
Time frame
1 hour after the exposure session2
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.
Time frame
1 hour after the exposure session3
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
Time frame
1 hour after the exposure session4
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
Time frame
1 hour after the exposure sessionSponsors and contacts
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Source ClinicalTrials.gov