Exposure to Environmental Heat and Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Changes of maximum expiratory flow rate at 25% vital capacity (MEF25)
研究概览
简要总结
This is a randomized controlled human exposure crossover study. Investigators aims to assess the acute effects of high temperature exposure and the underlying mechanisms.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be informed of the study interventions before providing informed consent but will be masked to the order of exposure (i.e., participants will not know the exposure conditions). Data will be blinded prior to analysis.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
High temperature group
This group including 24 healthy subjects will be exposed to high temperature for about 3 hours in a chamber.
干预措施: High temperature exposure (Other)
Moderate temperature group
This group including 24 healthy subjects will be exposed to moderate temperature for about 3 hours in a chamber.
干预措施: Moderate temperature exposure (Other)
结局指标
主要结局
Changes of maximum expiratory flow rate at 25% vital capacity (MEF25)
时间窗: 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)
时间窗: 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)
时间窗: 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.
Change of forced expired volume in the first second (FEV1)
时间窗: 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.
Inflammatory factors and antioxidant-related biomarkers in nasal cavity fluid
时间窗: Collect nasal fluid samples half an hour before exposure and half an hour after exposure
Inflammatory factors were detected by the ELASA
Systolic and diastolic blood pressure
时间窗: 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
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Differences in metabolic profiling detected in blood between the two exposures and before and after each exposure(Prior to and 1 hour after exposure)
- 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.)
- Differences in proteomics detected in nasal fluid between the two exposures and before and after each exposure(Prior to and 1 hour after exposure)
- Differences in transcriptome detected in blood between the two exposures and before and after each exposure(Prior to and 1 hour after exposure)
- 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 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 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.)
- 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.)
- Cerebral blood flow changes(Cerebral blood flow changes will be examed within half an hour before exposure and half an hour after exposure.)
- Differences in proteome detected in blood between the two exposures and before and after each exposure(Prior to and 1 hour after exposure)
- 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.)
研究者
Yinan Qu
Master
Shandong University