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Mediation effects of biochemical markers on the relationship between usual dietary intakes and risk of non-communicable chronic diseases in Chinese adults: the China Health and Nutrition Survey.
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注册号:

Registration number:

ChiCTR-ROC-17013095 

最近更新日期:

Date of Last Refreshed on:

2017-10-24 

注册时间:

Date of Registration:

2017-10-24 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

基于生化指标的日常摄入量与非传染性慢性疾病风险的中介分析研究——中国健康与营养调查 

Public title:

Mediation effects of biochemical markers on the relationship between usual dietary intakes and risk of non-communicable chronic diseases in Chinese adults: the China Health and Nutrition Survey. 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于生化指标的日常摄入量与非传染性慢性疾病风险的中介分析研究——中国健康与营养调查 

Scientific title:

Mediation effects of biochemical markers on the relationship between usual dietary intakes and risk of non-communicable chronic diseases in Chinese adults: the China Health and Nutrition Survey. 

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:

李凯风 

研究负责人:

罗永康 

Applicant:

Kaifeng Li 

Study leader:

Yongkang Luo 

申请注册联系人电话:

Applicant telephone:

+86 15011335637 

研究负责人电话:

Study leader's telephone:

+86 10-62737385 

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:

likaifeng@cau.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

luoyongkang@263.net 

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:

北京市海淀区圆明园西路2号中国农业大学理学院 B114 

研究负责人通讯地址:

北京海淀区清华东路17号中国农业大学112信箱 

Applicant address:

B114, College of Science, China Agricultural University, 2 Yuanmingyuan Road West, Haidian District, Beijing, China 

Study leader's address:

P.O.X 112, China Agricultural University, 17 Qinghua Donglu, 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:

北京食品营养与人类健康高精尖创新中心 

Applicant's institution:

Beijing Advanced Innovation Center for Food Nutrition and Human Health 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

中国农业大学 

Primary sponsor:

China Agricultural University 

研究实施负责(组长)单位地址:

北京市海淀区圆明园西路2号中国农业大学 

Primary sponsor's address:

2 Yuanmingyuan Road West, 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):

中国农业大学

具体地址:

北京市海淀区圆明园西路2号中国农业大学

Institution
hospital:

China Agricultural University

Address:

2 Yuanmingyuan Road West, Haidian District, Beijing, China

经费或物资来源:

本研究基于开放性队列数据:中国健康与营养调查。 

Source(s) of funding:

This research uses data from China Health and Nutrition Survey 

研究疾病:

非传染性慢性疾病 

Target disease:

non-communicable chronic diseases 

研究疾病代码:

 

Target disease code:

 

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

研究中国人群人体生化指标对日常摄入量与非传染性慢性疾病风险之间的中介效应。 

Objectives of Study:

To understand the potential dietary component of non-communicable chronic diseases, we examined the mediation effects of biochemical biomarkers on the relationship between usual food group intakes and risk of non-communicable chronic diseases using data from the China Health and Nutrition Survey (CHNS).  

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:

本研究基于既往的开放数据中国健康与营养调查,所有的数据收集和数据整理已在本研究开始前完成。本研究是对已有数据的选择和分析。根据不同慢性病类型和分析方法,本研究采取不同的纳入和排出标准。对于重复观测研究,纳入标准包括2000年到2009年至少参加一次调查,年满18周岁的成年人,未怀孕、未处于哺乳期、无肢体残疾,且基线协变量信息完整,至少有一次膳食数据完整。对于队列研究纳入2000-2009年,年满18周岁的成年人,不处于怀孕、哺乳期,无肢体残疾,且基线协变量信息完整,基线未诊断为糖尿病、心脑血管及疾病及其他任何慢性病,基线后有至少一次随访结局(对于需要用到生化指标的研究,纳入条件包含2009年参与随访),且在结局之前至少有一次膳食数据完整的研究对象。 

Inclusion criteria

This study is based on a publicly available open cohort which named the China Health and Nutrition Survey (CHNS). All the data used in present study have been collected which can be downloaded online. Different inclusion and exclusion criteria will be used based on different endpoint and study design used in present study. For repeated measurement analysis, inclusion criteria includes subjects aged over 18 years, who take part in the survey at least once during 2000 to 2009, female who are not pregnant and who are not lactating, subjects in 2000 with full dietary data, and subjects who are not diagnosed with heart disease or diabetes. For cohort analysis, inclusion criteria includes subjects (aged over 18 years) in 2000 with dietary intake data as baseline, female who are not pregnant and who are not lactating, subjects who are not diagnosed with heart disease or diabetes, subjects in 2009 with biochemistry data. 

排除标准:

本研究基于既往的开放数据中国健康与营养调查,所有的数据收集和数据整理已在本研究开始前完成。本研究是对已有数据的选择和分析。根据不同慢性病类型和分析方法,本研究采取不同的纳入和排出标准。对于重复观测研究,排除标准包括剔除18岁以下,怀孕、哺乳、肢体残疾,所有膳食数据缺失或异常、关键协变量(年龄、性别等)信息缺失。对于队列研究纳入2000-2009年,排除标准包括剔除18岁以下,怀孕、哺乳、肢体残疾,基线关键协变量(年龄、性别等)信息缺失者;进一步剔除待研究的慢性病(如糖尿病、肥胖、心脑血管疾病等)诊断信息不全或不完整者;基线时诊断为糖尿病、心脑血管疾病者。 

Exclusion criteria:

This study is based on a publicly available open cohort which named the China Health and Nutrition Survey (CHNS). All the data used in present study have been collected which can be downloaded online. Different inclusion and exclusion criteria will be used based on different endpoint and study design used in present study. For repeated measurement analysis, inclusion criteria excludes subjects aged under 18 years , female who are pregnant and who are lactating, subjects in 2000 with missing dietary data, and subjects who are diagnosed with heart disease or diabetes. For cohort analysis, exclusion criteria includes subjects aged under 18 years in 2000 with missing dietary intake data, female who are pregnant and who are lactating, subjects who are diagnosed with heart disease or diabetes, subjects in 2009 with missing biochemistry data. 

研究实施时间:

Study execute time:

From2017-04-03To 2019-03-29 

征募观察对象时间:

Recruiting time:

From2017-04-03To  

干预措施:

Interventions:

组别:

人群

样本量:

12732

Group:

Population

Sample size:

干预措施:

Non

干预措施代码:

Intervention:

Non

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):

中国农业大学 

单位级别:

大学 

Institution
hospital:

China Agricultural University  

Level of the institution:

University 

测量指标:

Outcomes:

指标中文名:

非传染性慢性疾病

指标类型:

主要指标 

Outcome:

non-communicable chronic diseases

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血压

指标类型:

主要指标 

Outcome:

Blood pressure

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体重、腰围、BMI

指标类型:

主要指标 

Outcome:

body weight, waist circumference and BMI

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

使用后保存 

说明

Fate of sample:

Preservation 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 years
最大 Max age 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):

本研究基于既往的开放研究项目中国健康与营养调查(简称 CHNS),研究对象征募过程在本研究开始之前已经完成,本研究只是对数据进行选择和分析,因此本研究没有随机化需求。

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

The present study is based on a publicly available prospective open cohort (the China Health and Nutrition Survey) with recruiting process being finished ahead of current study. Therefore, no randomization process is required for present study.

盲法:

Blinding:

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):

本研究的原始数据为既往研究的公开数据,原始数据可从如下网址下载获取:http://www.cpc.unc.edu/projects/china/.

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

The study is based on a publicly available prospective open cohort, the original database are available from: http://www.cpc.unc.edu/projects/china/.

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:

本研究的原始数据为既往研究的公开数据,所有的数据采集和管理已在本研究开始前完成。本研究只对已收集数据进行筛选和分析,因此无需数据采集和管理。

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

The study is based on a publicly available prospective open cohort, the data collection and management have been completed before the beginning of present study.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2017-10-24
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