Department of Environmental Health, School of Public Health, Fudan University
Shanghai, Shanghai Municipality, 200032, China
Location status: Recruiting
NCT Number: NCT06652425
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.
Interested in participating?
Request Info18 year–30 year
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200032, China
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The exposure group will be exposed to low temperature (15°C) in a chamber for about 2 hours, resting during the whole periods.
The exposure group will be exposed to thermoneutral temperature (22°C) in a chamber for about 2 hours, resting during the whole periods.
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.
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
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
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
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
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)
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
Time frame: Skin temperature will be examined during the 2-hour exposure session
The changes of wrist skin temperature will be measured
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.
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.
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
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Interested in participating?
Request InfoFudan University
Other
Acute Effects of Cold Exposure on Cardiovascular System and Potential Mechanism in Healthy Young Adults: A Randomized Controlled Study
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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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