Effects of Environmental Heat Exposure on Human Multiple Organ Function

NCT ID: NCT06938932

Last Updated: 2025-04-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-21
• Study Completion Date: 2027-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

High temperature group

This group including 24 healthy subjects will be exposed to high temperature for about 3 hours in a chamber.

Group Type: EXPERIMENTAL

High temperature exposure

Intervention Type: OTHER

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

Moderate temperature group

This group including 24 healthy subjects will be exposed to moderate temperature for about 3 hours in a chamber.

Group Type: SHAM_COMPARATOR

Moderate temperature exposure

Intervention Type: OTHER

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

Interventions

High temperature exposure

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

Intervention Type: OTHER

Moderate temperature exposure

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

Intervention Type: OTHER

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: collaborator

Yinan Qu

OTHER

Sponsor Role: lead

Responsible Party

Yinan Qu

Master

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Shandong University

Jinan, Shandong, China

Countries

China

Central Contacts

Qi Zhao PhD

Role: CONTACT

qi.zhao@sdu.edu.cn

+86 15550483437

Facility Contacts

Qi Zhao PhD

Role: primary

qi.zhao@sdu.edu.cn

+86 15550483437

Other Identifiers

LL20241102

Identifier Type: -

Identifier Source: org_study_id