Effects of Environmental Heat Exposure on Human Multiple Organ Function

Not Applicable

Not yet recruiting

• Conditions: Heat Stress Disorders; Body Temperature Changes; Wounds and Injuries; Multiple Organ Dysfunction

• Registration Number: NCT06938932
• Lead Sponsor: Yinan Qu

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-04
• Study First Submitted QC: 2025-04-14
• Last Update Submitted: 2025-04-14
• Study Start: 2025-04-21
• Study First Posted: 2025-04-22
• Last Update Posted: 2025-04-22
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Chinese nationality（aged 18-30 years healthy males and females）;
2. With ability to read and understand Chinese smoothly;
3. Living in Jinan during the study period;
4. Body mass index ≥ 18.5 and ≤ 28;
5. Normal resting ECG；
6. 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

1. Medications or dietary supplements intake that may alter body temperature during the study period;
2. 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;
3. Subjects with anemia, needle fainting and other signs unsuitable for blood drawing；
4. Subjects with cardiovascular diseases or other chronic medical condition, such as congenital heart disease, pulmonary heart disease, and hypertension, etc;
5. Subjects with a history of major cardio-vascular, respiratory, or nervous system surgery, etc;
6. Subjects with neurologic disorders, such as stroke, traumatic brain injury, epilepsy, and depression;
7. Subjects with allergic diseases, such as allergic rhinitis and allergic asthma, etc;
8. Subjects are pregnant, attempting to become pregnant or breastfeeding;
9. 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;
10. Subjects living with a smoker who smokes inside the house;
11. Subjects who are current drinking or have frequent alcohol use (defined as at least 1 time per week) in the past 6 months;
12. Provisional exclusion criteria, such as acute infection in the past two weeks or taking antibiotics. (Subjects can be enrolled after 2 weeks)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change of forced expired volume in the first second (FEV1)	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.
Systolic and diastolic blood pressure	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
Cardiac output	Cardiac output will be checked within half an hour before exposure and immediately after exposure.	Cardiac output will be measured by heart color ultrasound
Heart rate variability	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
Changes of forced vital capacity (FVC)	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.
Changes of peak expiratory flow rate (PEF)	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.
Changes of maximum expiratory flow rate at 25% vital capacity (MEF25)	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.
Changes of maximum expiratory flow rate at 50% vital capacity (MEF50)	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.
Changes of maximum expiratory flow rate at 75% vital capacity (MEF75)	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.

Secondary Outcome Measures

Name	Time	Method
Differences in metabolic profiling detected in blood between the two exposures and before and after each exposure	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.
Response event-related potentials (ERPs)	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.
Differences in transcriptome detected in blood between the two exposures and before and after each exposure	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.
EEG power in α band	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
EEG power in β band	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
EEG power in δ band	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
Frequency domain and energy ratio index, θ/β ratio	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
Cerebral blood flow changes	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
Differences in proteome detected in blood between the two exposures and before and after each exposure	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
EEG power in θ band	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

Trial Locations

Locations (1)

Shandong University; 🇨🇳 Jinan, Shandong, China