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The anti-obesity effects of Ligustrum robustum on human
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注册号:

Registration number:

ChiCTR-OOh-17011832 

最近更新日期:

Date of Last Refreshed on:

2017-07-02 

注册时间:

Date of Registration:

2017-07-02 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

粗壮女贞苦丁茶人体减肥效果 

Public title:

The anti-obesity effects of Ligustrum robustum on human 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

粗壮女贞苦丁茶人体减肥效果和机制研究 

Scientific title:

The anti-obesity effects and mechanism of Ligustrum robustum on human 

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:

周涛 

研究负责人:

裴晓方 

Applicant:

Tao Zhou 

Study leader:

Xiaofang Pei 

申请注册联系人电话:

Applicant telephone:

+86 18200585250 

研究负责人电话:

Study leader's telephone:

+86 13668214461 

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:

fxrsg@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

xxpeiscu@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:

四川省成都市武侯区人民南路三段16号四川大学华西公共卫生学院  

研究负责人通讯地址:

四川省成都市武侯区人民南路三段16号四川大学华西公共卫生学院  

Applicant address:

16 Renmin Road South, Wuhou District, Chengdu, Sichuan, China  

Study leader's address:

16 Renmin Road South, Wuhou District, Chengdu, Sichuan, China  

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

四川大学华西公共卫生学院 

Applicant's institution:

West China School of Public Health, Sichuan University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

K2016025 

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:

四川大学医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Sichuan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-10-13 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

四川大学华西公共卫生学院 

Primary sponsor:

West China School of Public Health, Sichuan University 

研究实施负责(组长)单位地址:

四川省成都市武侯区人民南路三段16号 

Primary sponsor's address:

16 Renmin Road South, Wuhou District, Chengdu, Sichuan, China  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

四川

市(区县):

Country:

China

Province:

Sichuan

City:

单位(医院):

四川大学华西公共卫生学院

具体地址:

四川省成都市武侯区人民南路三段16号

Institution
hospital:

West china school of public health, Sichuan university

Address:

16 Renmin Road South, Wuhou District, Chengdu, Sichuan, China

经费或物资来源:

四川省科技厅 

Source(s) of funding:

Science & Technology Department of Sichuan Province 

研究疾病:

肥胖 

Target disease:

Obesity 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

研究粗壮女贞苦丁茶对肥胖等代谢性疾病的影响及与肠道菌群的关系 

Objectives of Study:

To investigate the effect of Ligustrum robustum (LR) intake on weight changes and delineate the association between weight loss and gut microbiota. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1. 成年女性,年龄30-60岁;2.身体质量指数 (BMI) >24 kg/m2;3.签署知情同意书 

Inclusion criteria

1. Female aged between 30-60years; 2. body mass index (BMI) >24 kg/m2; 3. Informed consent was obtained 

排除标准:

1.使用减肥药物;2.患有影响体重的基础疾病;3.三个月内服用抗生素;4.依从性不足 

Exclusion criteria:

1. Using medications that affect body weight; 2. having a history of chronic illness; 3. antibiotic intake within 3 months before joining the study; 4. insufficient motivation to complete the study. 

研究实施时间:

Study execute time:

From2016-10-14To 2017-12-31 

征募观察对象时间:

Recruiting time:

From2016-10-14To 2016-10-30 

干预措施:

Interventions:

组别:

Case series

样本量:

30

Group:

Case series

Sample size:

干预措施:

粗壮女贞苦丁茶

干预措施代码:

Intervention:

Ligustrum robustum (LR)

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

四川大学华西公共卫生学院 

单位级别:

学院 

Institution
hospital:

West china school of public health, Sichuan university  

Level of the institution:

college 

测量指标:

Outcomes:

指标中文名:

体重

指标类型:

主要指标 

Outcome:

Weight

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肠道菌群

指标类型:

主要指标 

Outcome:

Gut microbiota

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血脂及蛋白水平

指标类型:

主要指标 

Outcome:

lipid and protein

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血糖

指标类型:

主要指标 

Outcome:

glucose

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

瘦素

指标类型:

主要指标 

Outcome:

leptin

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

粪便标本

组织:

Sample Name:

Fecal

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 30 years
最大 Max age 56 years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

非随机试验

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

No Randomization。

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

No

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):

www.medresman.org

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

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:

Resman

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

Resman

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:

 2017-07-02
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