Status:
NOT_YET_RECRUITING
Effects of Environmental Heat Exposure on Human Multiple Organ Function
Lead Sponsor:
Yinan Qu
Collaborating Sponsors:
Qilu Hospital of Shandong University
Conditions:
Heat Stress Disorders
Wounds and Injuries
Eligibility:
All Genders
18-30 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06938932
Start Date
April 21 2025
End Date
December 31 2027
Last Update
April 22 2025
Active Locations (1)
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1
Shandong University
Jinan, Shandong, China