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花色苷防治肥胖高血脂的人群干预研究
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注册号:

Registration number:

ChiCTR-TRC-08000240 

最近更新日期:

Date of Last Refreshed on:

2015-05-11 

注册时间:

Date of Registration:

2008-12-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

花色苷防治肥胖高血脂的人群干预研究 

Public title:

The effect of anthocyanins on obesity-related disease in obese adults with hyperlipidemia 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

花色苷类植物化学物抗动脉粥样硬化效应及分子机制研究 

Scientific title:

The study on anti-atherosclerosis effects and molecular mechanisms of anthocyanins 

研究课题代号(代码):

Study subject ID:

30730079 

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:

朱艳娜 

研究负责人:

凌文华 

Applicant:

Zhu Yanna 

Study leader:

Ling Wenhua 

申请注册联系人电话:

Applicant telephone:

+86 0 13632407152 

研究负责人电话:

Study leader's telephone:

+86 020 87331597 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

+86 020 87330446 

申请注册联系人电子邮件:

Applicant E-mail:

zhuyna@163.com 

研究负责人电子邮件:

Study leader's E-mail:

lingwh@mail.sysu.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:

广州市中山二路74号中山大学北校区公共卫生学院营养系516室 

研究负责人通讯地址:

广州市中山二路中山大学北校区营养系 

Applicant address:

Dept.of Nutrition, School of Public Health, Sun Yat-sen University, 74 Zhongshan Er Road, Guangzhou, China 

Study leader's address:

Zhongshan Er Road, Guangzhou, China 

申请注册联系人邮政编码:

Applicant postcode:

510080 

研究负责人邮政编码:

Study leader's postcode:

510080 

申请人所在单位:

中山大学公共卫生学院营养系 

Applicant's institution:

School of Public Health, Sun Yat-sen 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:

伦审[2008]2号 

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:

中山大学公共卫生学院医学伦理委员会 

Name of the ethic committee:

The ethic committee of school of public health, Sun Yat-sen University 

伦理委员会批准日期:

Date of approved by ethic committee:

2008-09-22 

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:

中山大学 

Primary sponsor:

Sun Yat-sen University 

研究实施负责(组长)单位地址:

广东省广州市新港西路135号 

Primary sponsor's address:

No.135, WestXingang Road, Guangzhou, 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):

Country:

China

Province:

Beijing

City:

单位(医院):

国家自然基金会

具体地址:

北京市海淀区双清路83号

Institution
hospital:

National Natural Science Foundation of China

Address:

No.83, Shuangqing Road, Haidian District, Beijing City

经费或物资来源:

国家自然科学基金 

Source(s) of funding:

National Natural Science Foundation of China 

研究疾病:

肥胖及相关疾病 

Target disease:

obesity and obesity-related disease 

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:

I期临床试验 

Study phase:

研究目的:

观察花色苷对肥胖高血脂的人群血脂、胰岛素、炎症、氧化应激和脂肪因子水平的影响,探讨花色苷对肥胖高血脂的人群的防治作用及可能的机制,为进一步深入了解花色苷的生物学作用,同时为肥胖和高血脂的防治提供一个全新的膳食途径,也为将花色苷开发为防治肥胖和高血脂的保健食品提供理论依据。 

Objectives of Study:

We wish to determine the effect of anthocyanins on the level of lipid, insulin, oxidative stress and adipose secreting factors in obesity subjects with hyperlipidemia. Furthermore, we will study the possibility of anthocyanins' effect, as a dietary supplement, on obesity and hyperlipidemia 

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体重指数(BMI)≥28.0 kg/m2,如果BMI≤27.9,若腰围 男性≥85cm,女性≥80cm者也诊断为肥胖。 ②总胆固醇(TC)≥5.72mmol/L。 ③年龄30岁~65岁,性别不限。 ④无糖尿病、急性心肌梗塞、脑血管意外病史者。 

Inclusion criteria

1. Body Mass Index (BMI)>=28.0 kg/m2, or male's waist>=85cm, female's waist>=80cm; 2. Total cholesterol (TC)>=5.72mmol/L. 

排除标准:

①体重在近3个月内有明显变化。 ②由下丘脑-垂体的炎症、肿瘤、创伤、消化道炎症、库欣综合症、甲状腺功能减退症及性腺功能减退症等疾病引起的继发性肥胖(此标准由体检后医生的诊断意见确定)。 ③合并严重肝肾功能不全及造血系统等严重疾病、半年内有外伤或手术史。 ④现正服用或近半年曾服用任何影响血脂、血糖代谢的药物,如降脂药、降糖药等。 

Exclusion criteria:

1. Obvious weight change in the past three months; 2. History of obesity with known cause; 3. Patients with a history of diabetes, an acute myocardial infarction and a stroke; 4. History or evidence of clinically significant liver disease, kidney disease, cancer or uncontrolled thyroid disease; 5. Recent use (within six months) of medications for regulating the level of lipid or blood glucose; 6. Pregnant or breast-feeding woman. 

研究实施时间:

Study execute time:

From2008-07-01To 2009-12-31 

干预措施:

Interventions:

组别:

对照组

样本量:

60

Group:

Group A

Sample size:

干预措施:

给予空白安慰剂胶囊6个月,其服用方法与干预组相同。

干预措施代码:

Intervention:

placebo capsule, other measures follow the interventional group

Intervention code:

组别:

干预组

样本量:

60

Group:

Group B

Sample size:

干预措施:

花色苷胶囊6个月,每日两次,每次两粒,餐后半小时服

干预措施代码:

Intervention:

Medox capsule, twice a day for 6 months, half an hour after meal to take capsules

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

中山大学第一附属医院黄埔院区,中山大学第三附属医院 

单位级别:

三甲医院 

Institution
hospital:

The 3th Affiliated Hospital of Sun Yat-sen University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

脂肪细胞分泌因子、胰岛素、血脂水平

指标类型:

主要指标 

Outcome:

adipose secreting factors, insulin, level of lipids

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

炎症因子、血小板聚集功能

指标类型:

次要指标 

Outcome:

inflammatory factors, platelet aggregation

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:

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 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):

随机数字表

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

Random Number Table

盲法:

受试者和研究者 是

Blinding:

subject and investigator: blinding

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:

即时公开/Real time access

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):

中山大学公共卫生学院营养系

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

Dept.of Nutrition, School of Public Health, Sun Yat-sen University

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:

中山大学公共卫生学院流行病与统计系

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

Zhongshan university school of public health epidemic and statistics department

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2008-12-10
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