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NCT Number: NCT06076629

Acute Health Effects of Low Temperature Exposure

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

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cardiovascular System Cognitive Function Respiratory System

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Environmental Health, School of Public Health, Fudan University

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

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 (16#) group

Other

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

Other

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

Primary outcomes

  1. Heart Rate Variability Parameters

    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) parameters (e.g., SDNN, PNN50, LF, HF)

  2. 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.

  3. Forced vital capacity

    Time frame: Lung function will be examined before exposure and half an hour after the exposure session

    Investigators plan to measure forced vital capacity (FVC) by spirometry

  4. Forced expiratory volume in one second

    Time frame: Lung function will be examined before exposure and half an hour after the exposure session

    Investigators plan to measure forced expiratory volume in one second (FEV1) by spirometry.

  5. Maximal mid-expiratory flow

    Time frame: Lung function will be examined before exposure and half an hour after the exposure session

    Investigators plan to measure maximal mid-expiratory flow (MMEF) by spirometry.

  6. Results of Stroop Tests

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

    Investigators plan to measure the changes of cognitive function using Stroop Test.

Secondary outcomes

  1. Changes of skin temperature

    Time frame: Skin temperature will be examined from 1:00 P.M. to 4:30 P.M. at the day of intervention

    The changes of wrist skin temperature will be measured

  2. Results of simple reaction time

    Time frame: Simple reaction time will be examined before exposure and immediately after the exposure session

    Investigators plan to measure the changes of cognitive function using visual simple reaction time test.

  3. Results of visual memory

    Time frame: Visual memory will be examined before exposure and immediately after the exposure session

    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.

  4. Activated brain regions demonstrating brain activity related to the low temperature exposure

    Time frame: MRI will be examined 1 hour after the exposure session

    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.

  5. Changes in cerebral hemodynamics demonstrating brain activity related to the low temperature exposure

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

    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

Other outcomes

  1. Differences in metabolites detected in blood between the two exposures

    Time frame: Blood will be collected 1 hour after the exposure session

    The differentially expressed metabolites in blood related to low temperature exposure will be detected by maspectrometry-based non-targeted metabolomics.

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

    Time frame: Blood will be collected 1 hour after the exposure session

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

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

    Time frame: Blood will be collected 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

  4. 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.

  5. Changes of scores of symptoms questionnaires

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

    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.

  6. Change in C reactive protein (CRP) concentrations

    Time frame: Blood will be collected 1 hour after the exposure session

    Change in the concentrations of C reactive protein in blood.

  7. Changes of facial secreted sebum composition

    Time frame: Facial sample will be collected half an hour after the exposure session

    Investigators plan to collect facial secreted sebum composition using Sebutape. The differential facial secreted sebum composition between the two groups would be further evaluated.

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2026
First posted
Oct 11, 2023
Registry last updated
Sep 2, 2026

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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