Cardiovascular System
Conditions
Keywords
Low temperature, Randomized controlled trial, Cardiovascular system
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.
Interventions
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.
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency domain measures: low frequency (LF), high frequency (HF), and LF/HF ratio | 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) |
| rMSSD (root mean square of successive differences) | 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 |
| pNN50 (Percentage of differences between adjacent RR intervals greater than 50 ms) | 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 |
| Blood Pressure | 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. |
| SDNN (standard deviation of NN intervals) | 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 |
| SDANN (standard deviation of the averages of RR intervals) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of skin temperature | Skin temperature will be examined during the 2-hour exposure session | The changes of wrist skin temperature will be measured |
| Changes of scores of symptoms questionnaires | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in serum Cholesterol concentrations | 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. |
| Change in serum Glucose concentrations | 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. |
| Change in serum HDL concentrations | 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. |
| Differences in metabolic profiling detected in blood between the two exposures | 1 hour after the exposure session | The differential metabolic profiling in blood related to high temperature exposurewill be detected by maspectrometrybased non-targeted metabolomics. |
| Change in serum LDL concentrations | 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. |
| Change in serum LPa concentrations | 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. |
| Change in serum TG concentrations | 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. |
| Change in serum Insulin concentrations | 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. |
| Differences in protein levels detected in blood between the two exposures | 1 hour after the exposure session | The differentially expressed proteins in blood related to high temperature exposure will be detected by non-targeted proteomics. |
| Differences in RNA expression levels detected in serum transcriptomics between the two exposures | 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 |
| Differences in DNA methylation levels detected in whole-blood between the two exposures | 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 |
| Changes of the scores of thermal sensation questionnaires | 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. |
| Change in serum CRP concentrations | 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. |
| Change in serum APOA1 concentrations | 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. |
| Change in serum APOB concentrations | 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. |
Countries
China
Contacts
Primary ContactRenjie Chen, PhD
Backup ContactHaidong Kan, PhD
Outcome results
None listed