Acute Health Effects of Low Temperature Exposure

Cognitive Function Clinical Trial

Official title:

Acute Health Effects of Low Temperature Exposure in Healthy Young Adults: A Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06076629
• Other study ID #: FDUEH-9
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 10, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Fudan University
• Contact: Haidong Kan, PhD
• Phone: +86-021-54237908
• Email: kanh[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized controlled human exposure crossover study. Investigators aims to assess the acute effects of low temperature exposure and the underlying mechanisms.

Description:

The investigators will conduct a randomized controlled human exposure crossover study among about 50 healthy young adults in Shanghai, China. Each subject will be exposed twice: once to the low temperature (16#) and once to the moderate temperature (22#) in a chamber for about 2-2.5 hours. During the exposure session, each subject will be requested to rest. Health examinations will be conducted immediately prior to exposure (within 1 hour before the exposure session), during the period of exposure, and after exposure (within 2 hours after the exposure session). Health examinations include spirometry, Holter monitoring, blood pressure tests, cognitive function tests, symptom questionnaires, and magnetic resonance imaging. Investigators plan to collect blood, urine, exhaled breath condensate, and oropharyngeal swabs samples.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular System
• Cognitive Function
• Respiratory System

Intervention

Other:
• Low temperature (16#) group
The exposure group will be exposed to low temperature (16#) in a chamber for about 2 hours, resting during the whole periods.
• Moderate temperature (22#) group
The exposure group will be exposed to thermoneutral temperature (22#) in a chamber for about 2 hours, resting during the whole periods.

Locations

Country	Name	City	State
China	Department of Environmental Health, School of Public Health, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Differences in metabolites detected in blood between the two exposures	The differentially expressed metabolites in blood related to low temperature exposure will be detected by maspectrometry-based non-targeted metabolomics.	Blood will be collected 1 hour after the exposure session
Other	Differences in protein levels detected in blood between the two exposures	The differentially expressed proteins in blood related to low temperature exposure will be detected by non-targeted proteomics.	Blood will be collected 1 hour after the exposure session
Other	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	Blood will be collected 1 hour after the exposure session
Other	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
Other	Changes of scores of symptoms questionnaires	Changes of scores of respiratory and cardiovascular symptoms questionnaires which ranged from 0 to 5. Zero score refers to no symptoms, and higher scores refer to more severe symptoms.	The questionnaires will be conducted before exposure and immediately after the exposure session
Other	Change in C reactive protein (CRP) concentrations	Change in the concentrations of C reactive protein in blood.	Blood will be collected 1 hour after the exposure session
Other	Changes of facial secreted sebum composition	Investigators plan to collect facial secreted sebum composition using Sebutape. The differential facial secreted sebum composition between the two groups would be further evaluated.	Facial sample will be collected half an hour after the exposure session
Primary	Heart Rate Variability Parameters	Investigators plan to measure heart rate variability (HRV) parameters (e.g., SDNN, PNN50, LF, HF)	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.
Primary	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
Primary	Forced vital capacity	Investigators plan to measure forced vital capacity (FVC) by spirometry	Lung function will be examined before exposure and half an hour after the exposure session
Primary	Forced expiratory volume in one second	Investigators plan to measure forced expiratory volume in one second (FEV1) by spirometry.	Lung function will be examined before exposure and half an hour after the exposure session
Primary	Maximal mid-expiratory flow	Investigators plan to measure maximal mid-expiratory flow (MMEF) by spirometry.	Lung function will be examined before exposure and half an hour after the exposure session
Primary	Results of Stroop Tests	Investigators plan to measure the changes of cognitive function using Stroop Test.	The tests will be conducted before exposure and immediately after the exposure session
Secondary	Changes of skin temperature	The changes of wrist skin temperature will be measured	Skin temperature will be examined from 1:00 P.M. to 4:30 P.M. at the day of intervention
Secondary	Results of simple reaction time	Investigators plan to measure the changes of cognitive function using visual simple reaction time test.	Simple reaction time will be examined before exposure and immediately after the exposure session
Secondary	Results of visual memory	Investigators plan to measure the changes of cognitive function using visual memory test. Every level, a number of tiles will flash white. The participants will be required to memorize them, and pick them again after the tiles are reset. Higher levels refer to better visual memory.	Visual memory will be examined before exposure and immediately after the exposure session
Secondary	Activated brain regions demonstrating brain activity related to the low temperature exposure	Investigators plan to conduct magnetic resonance imaging (MRI) after exposure. The MRI data will be processed through Data Processing and Analysis for Brain Imaging (DPABI) sofrware to obtain brain activity parameters, such as fractional amplitude of low-frequency fluctuation (fALFF). Brain regions that change after exposure between the two groups would be further idenfitied.	MRI will be examined 1 hour after the exposure session
Secondary	Changes in cerebral hemodynamics demonstrating brain activity related to the low temperature exposure	Investigators plan to conduct functional near-infrared spectroscopy (fNIRS) to measure the changes in oxygenated hemoglobin and deoxygenated hemoglobin after exposure. Matlab would be applied to process data and evaluate the changes in cerebral hemodynamics associated with low temperature exposure	fNIRS will be examined before exposure and immediately after the exposure session