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Completed

NCT Number: NCT06938932

Effects of Environmental Heat Exposure on Human Multiple Organ Function

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

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Key information

Conditions

Heat Stress Disorders Body Temperature Changes Multiple Organ Dysfunction Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shandong University

Jinan, Shandong, China

About this study

The objective of this study is to study changes in functions of multiple organs under heat exposure, which mainly include changes of cardiac function and lung function. In addition, biological samples such as blood samples, nasal fluid, and urine, etc were collected to explore changes in biomarkers such as complete blood count, liver function, kidney function, and inflammatory indicators, etc. Biochemical analysis and omics analysis were conducted to study the changes of human physiological function caused by heat exposure.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chinese nationality（aged 18-30 years healthy males and females）;
  • With ability to read and understand Chinese smoothly;
  • Living in Jinan during the study period;
  • Body mass index ≥ 18.5 and ≤ 28;
  • Normal resting ECG；
  • Normal lung function: i. Forced vital capacity (FVC)≥80% of that predicted for gender, ethnicity, age and height; ii. Forced expiratory volume in one second (FEV1) ≥80% of that predicted for gender, ethnicity, age and height; iii. FEV1/FVC ratio≥80% of predicted values.

Exclusion criteria

  • Medications or dietary supplements intake that may alter body temperature during the study period;
  • Individuals who have unspecified illnesses, which in the judgment of the investigators might increase the risk associated with heat exposure will be a basis for exclusion;
  • Subjects with anemia, needle fainting and other signs unsuitable for blood drawing；
  • Subjects with cardiovascular diseases or other chronic medical condition, such as congenital heart disease, pulmonary heart disease, and hypertension, etc;
  • Subjects with a history of major cardio-vascular, respiratory, or nervous system surgery, etc;
  • Subjects with neurologic disorders, such as stroke, traumatic brain injury, epilepsy, and depression;
  • Subjects with allergic diseases, such as allergic rhinitis and allergic asthma, etc;
  • Subjects are pregnant, attempting to become pregnant or breastfeeding;
  • Subjects who are currently smoking (including vaping, hookah and e-cigarette) or have smoking history within 1 year of study (defined as more than 1 pk/yr in the past year) or have a greater than equal to a 5 pack year smoking history;
  • Subjects living with a smoker who smokes inside the house;
  • Subjects who are current drinking or have frequent alcohol use (defined as at least 1 time per week) in the past 6 months;
  • Provisional exclusion criteria, such as acute infection in the past two weeks or taking antibiotics. (Subjects can be enrolled after 2 weeks)

Treatment and study plan

High temperature exposure

Other

Subjects will be exposed to 35 degree Celsius and 45% relative humidity for 3 hours, resting during the whole periods.

Moderate temperature exposure

Other

Subjects will be exposed to 24degree Celsius and 45% relative humidity for 3 hours, resting during the whole periods.

Primary outcomes

  1. Systolic and diastolic blood pressure

    Time frame: Systolic and diastolic blood pressure will be measured within 15 minutes before exposure and immediately after the exposure session, and every 15 minutes during exposure.

    Brachial arterial blood pressure will be measured

  2. Cardiac output

    Time frame: Cardiac output will be checked within half an hour before exposure and immediately after exposure.

    Cardiac output will be measured by heart color ultrasound

  3. Heart rate variability

    Time frame: Cardiac variability will be monitored in real time from half an hour before exposure to half an hour after exposure, with data automatically recorded every 8 seconds.

    Heart rate variability will be measured using 24-hour holter electrocardiogram

  4. Change of forced expired volume in the first second (FEV1)

    Time frame: FEV1 will be checked within half an hour before exposure and 15 minutes after exposure.

    The changes of FEV1 will be measured by a smart spirometer. Before the pulmonary function test, subjects will practice several times by themselves. During the examination, each subject stands and clamps the nose clip, and repeats the test, with the best result as the criterion.

  5. Changes of forced vital capacity (FVC)

    Time frame: FVC will be checked within half an hour before exposure and 15 minutes after exposure.

    The changes of FVC will be measured by a smart spirometer.

  6. Changes of peak expiratory flow rate (PEF)

    Time frame: PEF will be checked within half an hour before exposure and 15 minutes after exposure.

    The changes of PEF will be measured by a smart spirometer.

  7. Changes of maximum expiratory flow rate at 25% vital capacity (MEF25)

    Time frame: MEF25 will be checked within half an hour before exposure and 15 minutes after exposure.

    The changes of MEF25 will be measured by a smart spirometer.

  8. Changes of maximum expiratory flow rate at 50% vital capacity (MEF50)

    Time frame: MEF50 will be checked within half an hour before exposure and 15 minutes after exposure.

    The changes of MEF50 will be measured by a smart spirometer.

  9. Changes of maximum expiratory flow rate at 75% vital capacity (MEF75)

    Time frame: MEF75 will be checked within half an hour before exposure and 15 minutes after exposure.

    The changes of MEF75 will be measured by a smart spirometer.

  10. Inflammatory factors and antioxidant-related biomarkers in nasal cavity fluid

    Time frame: Collect nasal fluid samples half an hour before exposure and half an hour after exposure

    Inflammatory factors were detected by the ELASA

Secondary outcomes

  1. Differences in metabolic profiling detected in blood between the two exposures and before and after each exposure

    Time frame: Prior to and 1 hour after exposure

    The differential metabolic profiling in peripheral blood related to high temperature exposure will be detected by mass spectrometry-based non-targeted metabolomics.

  2. Differences in transcriptome detected in blood between the two exposures and before and after each exposure

    Time frame: Prior to and 1 hour after exposure

    The differential transcriptome in peripheral blood related to high temperature exposure will be detected by mass spectrometry-based non-targeted transcriptomics.

  3. Differences in proteome detected in blood between the two exposures and before and after each exposure

    Time frame: Prior to and 1 hour after exposure

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

  4. EEG power in α band

    Time frame: EEG power in α band will be measured immediately during the same exposure period the day before exposure and within half an hour of the end of the exposure day.

    EEG power in α band will be monitored by EEG measuring instrument

  5. EEG power in θ band

    Time frame: EEG power in θ band will be measured immediately during the same exposure period the day before exposure and within half an hour of the end of the exposure day.

    EEG power in θ band will be monitored by EEG measuring instrument

  6. EEG power in β band

    Time frame: EEG power in β band will be measured immediately during the same exposure period the day before exposure and within half an hour of the end of the exposure day.

    EEG power in β band will be monitored by EEG measuring instrument

  7. EEG power in δ band

    Time frame: EEG power in δ band will be measured immediately during the same exposure period the day before exposure and within half an hour of the end of the exposure day.

    EEG power in δ band will be monitored by EEG measuring instrument

  8. Response event-related potentials (ERPs)

    Time frame: ERPs will be measured immediately during the same exposure period the day before exposure and within half an hour of the end of the exposure day.

    ERPs will be monitored by EEG measuring instrument, including P300, N1/P1 and so on.

  9. Frequency domain and energy ratio index, θ/β ratio

    Time frame: θ/β ratio will be measured immediately during the same exposure period the day before exposure and within half an hour of the end of the exposure day.

    θ/β ratio will be monitored by EEG measuring instrument, which is an important parameter for response frequency domain and energy ratio index

  10. Cerebral blood flow changes

    Time frame: Cerebral blood flow changes will be examed within half an hour before exposure and half an hour after exposure.

    Cerebral blood flow changes will be measured by transcranial doppler

  11. Differences in proteomics detected in nasal fluid between the two exposures and before and after each exposure

    Time frame: Prior to and 1 hour after exposure

    Collect nasal fluid samples for proteomics analysis

Other outcomes

  1. Change in tumor necrosis factor-α (TNF-α) concentrations

    Time frame: Prior to and 1 hour after exposure

    TNF-α will be tested through blood samples

  2. Change in C reactive protein (CRP) concentrations

    Time frame: Prior to and 1 hour after exposure

    CRP will be tested through blood samples

  3. Change in interleukin-6 (IL-6) concentrations

    Time frame: Prior to and 1 hour after exposure

    IL-6 will be tested through blood samples

  4. Change in interleukin-1β (IL-1β) concentrations

    Time frame: Prior to and 1 hour after exposure

    IL-1β will be tested through blood samples

  5. Change in liver function indicators

    Time frame: Prior to and 1 hour after exposure

    Liver function indexes will be tested through blood samples, including glutamic-pyruvic transaminase (ALT), glutamic oxalacetic transaminase (AST), glutamyltranspeptidase (GGT), alkaline phosphatase (ALP), total protein (TP), albumin(ALB), total bilirubin (TBIL), direct bilirubin (DBIL) and so on.

  6. Change in kidney function indicators

    Time frame: Prior to and 1 hour after exposure

    Liver function indexes will be tested through blood samples, including urea nitrogen (BUN), creatinine (CR), Cystatin C (CYS C) and so on.

  7. Change in Uric Acid (UA)

    Time frame: Prior to and 1 hour after exposure

    UA will be tested through blood samples

  8. Change in myocardial and vascular injury indicators

    Time frame: Prior to and 1 hour after exposure

    myocardial and vascular injury indicators will be tested through blood samples, including creatine kinase (CK), Creatine Kinase Isoenzyme (CKMB), lactic dehydrogenase (LDH), α-hydroxybutyrate kinase and so on.

  9. Change in coagulation indicators

    Time frame: Prior to and 1 hour after exposure

    Coagulation indicators will be tested through prothrombin time(PT), activated partial thromboplastin time (APTT), plasma fibrinogen (FIB), thrombin time (TT) and so on.

  10. Blood routine examination

    Time frame: Prior to and 1 hour after exposure

    A routine test in the blood test, including red blood cells, white blood cells, platelets and other aspects of the test.

  11. Routine urianlysis

    Time frame: Prior to and 1 hour after exposure

    A routine test in the urine sample, including urine specific gravity and so on.

  12. Change in D-lactic acid

    Time frame: Prior to and 1 hour after exposure

    D-lactic acid will be tested through blood samples

  13. Change in diamine oxidase(DAO)

    Time frame: Prior to and 1 hour after exposure

    DAO will be tested through blood samples

  14. Weight

    Time frame: Prior to exposure and immediately after the exposure session

    Weight will be measured using a scale, wearing only short-sleeved shorts and slippers

Sponsors and collaborators

Lead sponsor

Yinan Qu

Other

Collaborators

  • Qilu Hospital of Shandong University

Registry information

Official study title

Exposure to Environmental Heat and Intervention Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 22, 2025
Registry last updated
May 14, 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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