Effects of Environmental Heat Exposure on Human Multiple Organ Function

N/ANot Yet RecruitingNCT06938932

Yinan Qu24 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Heat Stress Disorders Wounds and Injuries Body Temperature Changes Multiple Organ Dysfunction

Interventions

High temperature exposureOTHER

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

Moderate temperature exposureOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 30 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Shandong University

Jinan, Shandong, China

Outcomes

Primary Outcomes

Systolic and diastolic blood pressure

Brachial arterial blood pressure will be measured

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.

Cardiac output

Cardiac output will be measured by heart color ultrasound

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

Heart rate variability

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

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.

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

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.

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

Changes of forced vital capacity (FVC)

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

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

Changes of peak expiratory flow rate (PEF)

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

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

Central Contacts

Qi Zhao PhD

CONTACT

+86 15550483437 qi.zhao@sdu.edu.cn

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

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

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

Time frame: Prior to and 1 hour after exposure

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

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

Time frame: Prior to and 1 hour after exposure

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

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

Time frame: Prior to and 1 hour after exposure

EEG power in α band

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

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 θ band

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

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 β band

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

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 δ band

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

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.

Response event-related potentials (ERPs)

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

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.

Frequency domain and energy ratio index, θ/β ratio

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

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.

Cerebral blood flow changes

Cerebral blood flow changes will be measured by transcranial doppler

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