常温水与低温水影响人渴觉脑功能的研究

注册号:

Registration number:

ChiCTR2600124372 

最近更新日期:

Date of Last Refreshed on:

2026-05-11 16:32:45 

注册时间:

Date of Registration:

2026-05-11 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

常温水与低温水影响人渴觉脑功能的研究

Public title:

Effects of Room-Temperature and Cool Water on the Human Brain Function Related to Thirst Perception

注册题目简写:

English Acronym:

研究课题的正式科学名称:

常温水与低温水影响人渴觉脑功能的研究

Scientific title:

Effects of Room-Temperature and Cool Water on the Human Brain Function Related to Thirst Perception

研究课题代号(代码):

Study subject ID:

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

申请注册联系人:

李松 

研究负责人:

李松 

Applicant:

Song Li 

Study leader:

Song Li 

申请注册联系人电话:

Applicant telephone:

+86 23 6877 4410

研究负责人电话:

Study leader's
telephone:

+86 23 6877 4410

申请注册联系人传真 :

Applicant Fax:

研究负责人传真:

Study leader's fax:

申请注册联系人电子邮件:

Applicant E-mail:

dlisong3@163.com

研究负责人电子邮件:

Study leader's E-mail:

dlisong3@163.com

申请单位网址(自愿提供):

Applicant website(voluntary supply):

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

申请注册联系人通讯地址:

重庆市沙坪坝区新桥正街83号

研究负责人通讯地址:

重庆市沙坪坝区新桥正街83号

Applicant address:

No. 83 Xinqiao Zhengjie, Shapingba District, Chongqing

Study leader's address:

No. 83 Xinqiao Zhengjie, Shapingba District, Chongqing

申请注册联系人邮政编码:

Applicant postcode:

400037

研究负责人邮政编码:

Study leader's postcode:

400037

申请人所在单位:

陆军军医大学第二附属医院

Applicant's institution:

Second Affiliated Hospital of Army Medical University

研究负责人所在单位:

陆军军医大学第二附属医院

Affiliation of the Leader:

Second Affiliated Hospital of Army Medical University

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

2025-研第236-01

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

中国人民解放军陆军军医大学第二附属医院医学伦理委员会

Name of the ethic committee:

Medical ethics committee of the Second Affiliated Hospital of the PLA Army Medical Universit

伦理委员会批准日期:

Date of approved by ethic committee:

2025-07-08 00:00:00

伦理委员会联系人:

胡岚岚

Contact Name of the ethic committee:

Lanlan Hu

伦理委员会联系地址:

陆军军医大学第二附属医院图书馆二楼医学伦理委员会办公室

Contact Address of the ethic committee:

Medical ethics committee office on the second floor of the library of the Second Affiliated Hospital of the Army Medical University

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 23 6875 5422

伦理委员会联系人邮箱:

Contact email of the ethic committee:

研究实施负责(组长)单位:

陆军军医大学第二附属医院

Primary sponsor:

Second Affiliated Hospital of Army Medical University

研究实施负责(组长)单位地址:

重庆市沙坪坝区新桥正街83号

Primary sponsor's address:

No. 83 Xinqiao Zhengjie, Shapingba District, Chongqing

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

重庆市

市(区县):

Country:

China

Province:

Chongqing

City:

单位(医院):

陆军军医大学第二附属医院

具体地址:

重庆市沙坪坝区新桥正街83号

Institution
hospital:

Second Affiliated Hospital of Army Medical University

Address:

No. 83 Xinqiao Zhengjie, Shapingba District, Chongqing

经费或物资来源:

本单位自筹

Source(s) of funding:

Self raised by the unit

研究疾病:

渴觉  

Target disease:

thirst

研究疾病代码:

Target disease code:

研究类型:

干预性研究

Study type:

Interventional study

研究所处阶段:

探索性研究/预试验 

Study phase:

0

研究设计:

单病例随机对照研究 

Study design:

N of 1 Trial 

研究目的:

鉴于人脑渴觉对人生存的重要性,针对目前渴觉产生、缓解的神经网络机制不明现状,本研究拟采用无创功能核磁研究方法,研究健康志愿者不同饮水行为对脑功能网络的影响,探讨渴觉产生、消退的神经网络机制。  

Objectives of Study:

Given the importance of the brain's thirst perception to human survival, and despite the current lack of clarity regarding the neural network mechanisms underlying the generation and relief of thirst, this study aims to investigate the effects of different water consumption behaviors on the brain's functional network in healthy volunteers using non-invasive functional magnetic resonance imaging (fMRI). The goal is to explore the neural network mechanisms involved in the generation and satiation of thirst.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

1.饮水偏好或者障碍者; 2.服用呋塞米、氢氯噻嗪、托伐普坦影响水盐代谢的药物; 3.女性月经期; 4.其他可能影响精神心理状态的疾病或药物; 5.常见急慢性疾病(糖尿病、高血压、甲亢、各部位急慢性感染、冠心病); 6.免疫性疾病。

Exclusion criteria:

1. People with drinking preference or barriers; 2. Taking drugs that affect water and salt metabolism such as furosemide, hydrochlorothiazide and tolvaptan; 3. Women's menstrual period; 4. Other diseases or drugs that may affect mental and psychological status; 5. Common acute and chronic diseases (diabetes, hypertension, hyperthyroidism, acute and chronic infections in various parts, coronary heart disease); 6. Immune diseases.

研究实施时间:

Study execute time:

From 2025-07-07 00:00:00 To 2026-12-01 00:00:00  

征募观察对象时间:

Recruiting time:

From 2025-07-08 00:00:00 To 2026-12-01 00:00:00

干预措施:

Interventions:

组别:

试验组

样本量:

30

Group:

Test group

Sample size:

干预措施:

服用常温水与低温水,顺序随机

干预措施代码:

Intervention:

Drinking room temperature water and cool water,random order.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

重庆市 

市(区县):

 

Country:

China

Province:

Chongqing

City:

单位(医院):

陆军军医大学第二附属医院 

单位级别:

三甲 

Institution
hospital:

Second Affiliated Hospital of Army Medical University

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

血氧水平依赖功能磁共振成像

指标类型:

主要指标

Outcome:

BOLD-fMRI

Type:

Primary indicator

测量时间点:

饮水前后

测量方法:

3.0T 核磁扫描

Measure time point of outcome:

Before and after drinking water

Measure method:

3.0T MR scanning

指标中文名:

渴觉评分

指标类型:

主要指标

Outcome:

thirst score

Type:

Primary indicator

测量时间点:

饮水前后

测量方法:

NRS渴觉评分量

Measure time point of outcome:

Before and after drinking water

Measure method:

Numeric Rating Scale

指标中文名:

饮水量

指标类型:

次要指标

Outcome:

water intake

Type:

Secondary indicator

测量时间点:

饮水后

测量方法:

量杯测量

Measure time point of outcome:

After drinking water

Measure method:

Measuring cup

指标中文名:

动脉自旋标记

指标类型:

主要指标

Outcome:

Arterial Spin Labeling, ASL

Type:

Primary indicator

测量时间点:

饮水前后

测量方法:

3.0T 核磁扫描

Measure time point of outcome:

Before and after drinking water

Measure method:

3.0T MR scanning

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

None

Tissue:

人体标本去向

其它  

说明

Fate of sample:

0thers  

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 20 years
最大 Max age 40 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

采用随机数字表法决定饮水顺序,奇数者采取先常温后冰水的顺序,偶数者采取先冰水后常温的顺序。

Randomization Procedure (please state who generates the random number sequence and by what method):

The drinking sequence was determined using a random number table method, with odd numbers following the order of room temperature water followed by ice water, and even numbers following the order of ice water followed by room temperature water.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法:

Blinding:

none

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

是Yes

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

临床试验公共管理平台ResMan(www.medresman.org)

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

ResMan(www.medresman.org)

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

电子采集和管理系统

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Electronic Data Capture

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2026-05-11 16:32:29