Clinical trial NCT06938932: Effects of Environmental Heat Exposure on Human Multiple Organ Function
Official title: Exposure to Environmental Heat and Intervention Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Heat Stress Disorders
Wounds and Injuries
Body Temperature Changes
Multiple Organ Dysfunction
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Qilu Hospital of Shandong University
First posted: 2025-04-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Systolic and diastolic blood pressure
timeFrame: 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.
measure: Cardiac output
timeFrame: Cardiac output will be checked within half an hour before exposure and immediately after exposure.
measure: Heart rate variability
timeFrame: 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.
measure: Change of forced expired volume in the first second (FEV1)
timeFrame: FEV1 will be checked within half an hour before exposure and 15 minutes after exposure.
measure: Changes of forced vital capacity (FVC)
timeFrame: FVC will be checked within half an hour before exposure and 15 minutes after exposure.
measure: Changes of peak expiratory flow rate (PEF)
timeFrame: PEF will be checked within half an hour before exposure and 15 minutes after exposure.
measure: Changes of maximum expiratory flow rate at 25% vital capacity (MEF25)
timeFrame: MEF25 will be checked within half an hour before exposure and 15 minutes after exposure.
measure: Changes of maximum expiratory flow rate at 50% vital capacity (MEF50)
timeFrame: MEF50 will be checked within half an hour before exposure and 15 minutes after exposure.
measure: Changes of maximum expiratory flow rate at 75% vital capacity (MEF75)
timeFrame: MEF75 will be checked within half an hour before exposure and 15 minutes after exposure.
Secondary outcomes:
measure: Differences in metabolic profiling detected in blood between the two exposures and before and after each exposure
timeFrame: Prior to and 1 hour after exposure
measure: Differences in transcriptome detected in blood between the two exposures and before and after each exposure
timeFrame: Prior to and 1 hour after exposure
measure: Differences in proteome detected in blood between the two exposures and before and after each exposure
timeFrame: Prior to and 1 hour after exposure
measure: EEG power in α band
timeFrame: 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.
measure: EEG power in θ band
timeFrame: 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.
measure: EEG power in β band
timeFrame: 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.
measure: EEG power in δ band
timeFrame: 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.
measure: Response event-related potentials (ERPs)
timeFrame: 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.
measure: Frequency domain and energy ratio index, θ/β ratio
timeFrame: 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.
measure: Cerebral blood flow changes
timeFrame: Cerebral blood flow changes will be examed within half an hour before exposure and half an hour after exposure.
Other outcomes:
measure: Change in tumor necrosis factor-α (TNF-α) concentrations
timeFrame: Prior to and 1 hour after exposure
measure: Change in C reactive protein (CRP) concentrations
timeFrame: Prior to and 1 hour after exposure
measure: Change in interleukin-6 (IL-6) concentrations
timeFrame: Prior to and 1 hour after exposure
measure: Change in interleukin-1β (IL-1β) concentrations
timeFrame: Prior to and 1 hour after exposure
measure: Change in liver function indicators
timeFrame: Prior to and 1 hour after exposure
measure: Change in kidney function indicators
timeFrame: Prior to and 1 hour after exposure
measure: Change in Uric Acid (UA)
timeFrame: Prior to and 1 hour after exposure
measure: Change in myocardial and vascular injury indicators
timeFrame: Prior to and 1 hour after exposure
measure: Change in coagulation indicators
timeFrame: Prior to and 1 hour after exposure
measure: Blood routine examination
timeFrame: Prior to and 1 hour after exposure
measure: Routine urianlysis
timeFrame: Prior to and 1 hour after exposure
measure: Change in D-lactic acid
timeFrame: Prior to and 1 hour after exposure
measure: Change in diamine oxidase(DAO)
timeFrame: Prior to and 1 hour after exposure
measure: Weight
timeFrame: Prior to exposure and immediately after the exposure session
Locations:
city: Jinan
country: China
facility: Shandong University
state: Shandong
Study officials:
References: