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燕麦对高胆固醇人群血胆固醇影响的人群试验
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注册号:

Registration number:

ChiCTR1800018641 

最近更新日期:

Date of Last Refreshed on:

2018-10-01 

注册时间:

Date of Registration:

2018-09-30 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

燕麦对高胆固醇人群血胆固醇影响的人群试验 

Public title:

Effect of oats on blood cholesterol in high cholesterol population 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

燕麦对高胆固醇人群血胆固醇影响的人群试验 

Scientific title:

Effect of oats on blood cholesterol in high cholesterol population 

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:

魏九玲 

研究负责人:

杨晓光 

Applicant:

Wei Jiuling 

Study leader:

Yang Xiaoguang 

申请注册联系人电话:

Applicant telephone:

+86 18813084983 

研究负责人电话:

Study leader's telephone:

+86 18813084983 

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:

18813084983@163.com 

研究负责人电子邮件:

Study leader's E-mail:

18813084983@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:

北京市丰台区右安门东滨河路4号A513 

研究负责人通讯地址:

北京市丰台区右安门东滨河路4号A513 

Applicant address:

A513, 4 Binhe Road East, You'anmen, Fengtai District, Beijing, China 

Study leader's address:

A513, 4 Binhe Road East, You'anmen, Fengtai 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:

中国营养学会营养与保健食品分会 

Applicant's institution:

China Nutrition Society Nutrition and Health Food Branch 

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:

ChiECRCT-20180139 

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:

中国注册临床试验伦理审查委员会 

Name of the ethic committee:

China Ethics Committee of Registering Clinical Trials  

伦理委员会批准日期:

Date of approved by ethic committee:

2018-09-16 

伦理委员会联系人:

米娜 

Contact Name of the ethic committee:

M ina 

伦理委员会联系地址:

中国香港特别行政区九龙塘浸会大学道中国临床试验注册中心香港中心  

Contact Address of the ethic committee:

Chinese Clinical Trial Registry Hong Kong Center, Hong Kong Baptist University Road, Hong Kong SAR, China  

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:

中国营养学会营养与保健食品分会 

Primary sponsor:

Nutrition and Healthy Food committe of Chineses Nutrition Society 

研究实施负责(组长)单位地址:

北京市丰台区右安门东滨河路4号 

Primary sponsor's address:

4 Binhe Road East, You'anmen, Fengtai 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(区县):

北京

Country:

China

Province:

Beijing

City:

Beijing

单位(医院):

中国营养学会营养与保健食品分会

具体地址:

北京市丰台区右安门东滨河路4号

Institution
hospital:

Nutrition and Healthy Food committe of Chineses Nutrition Society

Address:

4 Binhe Road East, You'anmen, Fengtai District, Beijing, China

经费或物资来源:

百事食品(中国)有限公司 

Source(s) of funding:

Pepsico 

研究疾病:

高胆固醇血症 

Target disease:

Hypercholesterolemia patients 

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:

其它 

Study phase:

N/A 

研究目的:

比较食用燕麦与食用对照食物对高胆固醇人群血胆固醇的影响。 

Objectives of Study:

This study is to prove whether oat β-glucan at the level of 3g/day having the effect of lowering blood cholesterol among Chinese population. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1、年龄在18-65周岁的男性或女性,BMI<28kg/㎡; 2、血清5.18≤TC≤6.21mmol/L且TG≤2.25mmol/L(保健食品功能评价程序); 3、无严重肝、肾、消化道疾病及糖尿病等代谢性疾病; 4、3月内未使用降低血脂相关药物,同意在实验期间不使用药物; 5、在听取项目介绍后自愿参加本研究,并签订知情同意书。 

Inclusion criteria

1. Male or female aged 18-65 years, BMI <28kg/m2; 2. Choosing the subjects of serum total cholesterol ranged 5.18-6.21 mmol/L and serum triglyceride ≦2.25 mmol/L; 3. Obtaining informed consent and voluntarily participating in the trial. 

排除标准:

1、年龄在18岁以下或65岁以上者,BMI≥28kg/㎡; 2、妊娠或哺乳期妇女; 3、合并有心、肝、肾和造血系统等严重疾病,精神病患者; 4、近3月曾服用降胆固醇药物,影响到对结果的判断者; 5、近6月内日常摄入燕麦或其他富含β-葡聚糖的食物; 6、过度抽烟或酗酒者; 7、有特殊的饮食习惯:素食者、体重管理者、生酮饮食者(高脂肪、低碳 水)等; 8、不能遵循试验要求者。 

Exclusion criteria:

1. The pregnant or lactating women, allergic constitution or allergy to the test sample 2. Combining serious diseases such as heart, liver, kidney and hematopoietic system, mentally ill patients 3. Using lipid-lowering drugs in the previous at least 3 months 4. Excessive smoking or alcohol 5. without normal dietary habits: the vegetarian, weight management, Ketogenic diet(high fat, low carbs), etc; 6. Regularly consume oatmeal or other beta-glucan within 6 months; 7. With high habitual intake of whole-grain foods; 8. The hospital in-patients with hyperlipidemia; 9. Not consumed according to the regulations, or the data are incomplete. 

研究实施时间:

Study execute time:

From2018-09-26To 2018-12-31 

征募观察对象时间:

Recruiting time:

From2018-10-08To 2018-12-31 

干预措施:

Interventions:

组别:

燕麦组

样本量:

105

Group:

Oat meals

Sample size:

干预措施:

燕麦

干预措施代码:

Intervention:

Oat meal

Intervention code:

组别:

米片

样本量:

105

Group:

rice

Sample size:

干预措施:

米片

干预措施代码:

Intervention:

rice

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):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

白纸坊社区卫生服务中心 

单位级别:

社区卫生服务中心 

Institution
hospital:

Baizhifang Community Health Service Center  

Level of the institution:

Community Health Service Center 

国家:

中国 

省(直辖市):

江苏 

市(区县):

南京 

Country:

China 

Province:

Jiangsu 

City:

Nanjing 

单位(医院):

东南大学 

单位级别:

大学 

Institution
hospital:

Southeast University  

Level of the institution:

University 

国家:

中国 

省(直辖市):

上海 

市(区县):

上海 

Country:

China 

Province:

Shanghai 

City:

Shanghai 

单位(医院):

华东医院 

单位级别:

三甲医院 

Institution
hospital:

China East Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

血胆固醇

指标类型:

主要指标 

Outcome:

TC

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血甘油三酯

指标类型:

主要指标 

Outcome:

TG

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

低密度脂蛋白胆固醇

指标类型:

主要指标 

Outcome:

LDL-C

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

高密度脂蛋白胆固醇

指标类型:

主要指标 

Outcome:

HDL-C

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:

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 65 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):

分层分组、随机数字表法

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

Hierarchical grouping, random number table method

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

2019年7月 以文章及专利的附件形式

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

In July 2019, In terms of articles and patents

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:

以文章及专利的附件形式

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

In the form of articles and patents

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-09-30
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