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The effect of Usana meal replacement on weight loss in overweight and obesity subjects
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注册号:

Registration number:

ChiCTR-OOC-17012000 

最近更新日期:

Date of Last Refreshed on:

2017-07-15 

注册时间:

Date of Registration:

2017-07-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

葆苾康代餐粉减重研究 

Public title:

The effect of Usana meal replacement on weight loss in overweight and obesity subjects 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

葆苾康代餐粉减重研究 

Scientific title:

The effect of Usana meal replacement on weight loss in overweight and obesity subjects 

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:

郭晓晖 

研究负责人:

马冠生 

Applicant:

Xiaohui Guo 

Study leader:

Guansheng Ma 

申请注册联系人电话:

Applicant telephone:

+86 13261581640 

研究负责人电话:

Study leader's telephone:

+86 13801080336 

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:

guoxiaohui@bjmu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

mags@bjmu.edu.cn 

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:

北京市海淀区学院路38号 北京大学公共卫生学院 

研究负责人通讯地址:

北京市海淀区学院路38号 北京大学公共卫生学院 

Applicant address:

School of Public Health, Peking University Health Science Center, 38 Xueyuan Road, Haidian District, Beijing, China 

Study leader's address:

School of Public Health, Peking University Health Science Center, 38 Xueyuan Road, Haidian District, Beijing, 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:

北京大学公共卫生学院 

Applicant's institution:

School of Public Health, Peking University Health Science Center 

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:

IRB00001052-17058 

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:

北京大学生物医学伦理委员会 

Name of the ethic committee:

Peking University Institutional Review Board Office 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-07-06 

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:

北京大学医学部 

Primary sponsor:

Peking University Health Science Center 

研究实施负责(组长)单位地址:

北京市海淀区学院路38号 北京大学医学部 

Primary sponsor's address:

38 Xueyuan Road, Haidian District, Beijing, 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):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京大学医学部

具体地址:

北京市海淀区学院路38号

Institution
hospital:

Peking University Health Science Center

Address:

38 Xueyuan Road, Haidian District, Beijing, China

经费或物资来源:

葆婴有限公司 

Source(s) of funding:

BabyCare Ltd. 

研究疾病:

减重研究 

Target disease:

Weight loss study 

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:

代餐膳食对超重,肥胖志愿者的减重效果 

Objectives of Study:

To study the effect of a meal replacement on weight loss in overweight and obesity subjects 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

1 健康,BMI >24的志愿者。年龄18-55周岁。居住地在北京、天津、石家庄三个城市之一。 2 目前没有参加任何与减肥相关的活动。 3 因代餐粉内含有谷类,豆坚果等食物成分受试者对已知品无过敏反应。 4 受试者目前处于非怀孕、哺乳期,且并无意向准备受试者。 

Inclusion criteria

1. Healthy participants with BMI >24, and aged between 18-55 years old. Live in Beijing or Tianjin Or Shijiangzhuang; 2. Currently, did not participant in any weight loss activity; 3. Do not have any allergy action to the food ingredient; 4. Currently were not being under pregnancy or not intend to be pregnancy. 

排除标准:

1 被诊断有认知障碍,精神分裂,抑郁症患者; 2 酗酒; 3 体内装有电子起搏器; 4 曾经做过减肥手术; 5 饮食作息不规律; 

Exclusion criteria:

1. Being diagnosed with cognitive impairment, schizophrenia, and depression; 2. Alcoholism; 3. Equipped with electronic device inbody; 4. Being erformed weight loss surgery before; 5. Irregular diet and work. 

研究实施时间:

Study execute time:

From2017-08-01To 2017-11-30 

征募观察对象时间:

Recruiting time:

From2017-07-15To 2017-07-31 

干预措施:

Interventions:

组别:

干预组

样本量:

100

Group:

Intervention group and Control group

Sample size:

干预措施:

晚餐使用代餐粉代替晚餐

干预措施代码:

Intervention:

Dinner meal replaced by meal replacement

Intervention code:

组别:

空白对照组

样本量:

100

Group:

Control Group

Sample size:

干预措施:

不做任何措施

干预措施代码:

Intervention:

Non-intervention

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学医学部 

单位级别:

高校 

Institution
hospital:

Peking University Health Science center  

Level of the institution:

University 

测量指标:

Outcomes:

指标中文名:

体重

指标类型:

主要指标 

Outcome:

Body 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:

身高

指标类型:

主要指标 

Outcome:

Height

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体成分

指标类型:

主要指标 

Outcome:

Body composition

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:

次要指标 

Outcome:

Glucose

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血脂

指标类型:

次要指标 

Outcome:

Blood lipids

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血压

指标类型:

次要指标 

Outcome:

Blood Pressrue

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

腰围

指标类型:

主要指标 

Outcome:

Waist Circumference

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肠道微生物

指标类型:

次要指标 

Outcome:

Gut microbes

Type:

Secondary 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 samples

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 55 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):

简单随机抽样

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

Simple Randomization

盲法:

Blinding:

是否共享原始数据:

IPD sharing

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

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

Clinical Trial Management Public Platform

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:

数据采集:病例记录表;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:

Case Record Form and ResMan

数据与安全监察委员会:

Data and Safety Monitoring Committee:

注册人:

Name of Registration:

 2017-07-15
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