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蔬菜芽球菊苣酚酸类和倍半萜类化合物人体生物利用度的研究
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注册号:

Registration number:

ChiCTR1800014393 

最近更新日期:

Date of Last Refreshed on:

2018-09-14 

注册时间:

Date of Registration:

2018-01-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

蔬菜芽球菊苣酚酸类和倍半萜类化合物人体生物利用度的研究 

Public title:

The bioavailability of phenolic acids and sesquiterpenoids of chicory in healthy human volunteers 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

蔬菜芽球菊苣酚酸类和倍半萜类化合物人体生物利用度的研究 

Scientific title:

The bioavailability of phenolic acids and sesquiterpenoids of chicory in healthy human volunteers 

研究课题代号(代码):

Study subject ID:

国家自然科学基金面上项目(No. 81573141) 

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:

郑嘉坤 

研究负责人:

王冬亮 

Applicant:

Jiakun Zheng 

Study leader:

Dongliang Wang 

申请注册联系人电话:

Applicant telephone:

+86 13580713826 

研究负责人电话:

Study leader's telephone:

+86 18819154596 

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:

334950589@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

wdliang@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:

广东省广州市越秀区中山二路74号 

研究负责人通讯地址:

广东省广州市越秀区中山二路74号 

Applicant address:

74 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, China 

Study leader's address:

74 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, 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:

中山大学 

Applicant's institution:

Sun Yat-Sen Universit 

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:

2017-009 

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生物医学研究伦理审查委员会 

Name of the ethic committee:

The committee on ethical review of biomedical research at the school of public health of sun yat-sen university 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

周倩 

Contact Name of the ethic committee:

Qian Zhou 

伦理委员会联系地址:

广东省广州市越秀区中山二路74号 

Contact Address of the ethic committee:

74 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, 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:

中山大学 

Primary sponsor:

Sun Yat-Sen Universit 

研究实施负责(组长)单位地址:

广东省广州市越秀区中山二路74号 

Primary sponsor's address:

74 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, 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):

广东省

市(区县):

Country:

China

Province:

Guangdong

City:

单位(医院):

中山大学

具体地址:

广东省广州市越秀区中山二路74号

Institution
hospital:

Sun Yat-Sen Universit

Address:

74 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, China

经费或物资来源:

国家自然科学基金面上项目(No. 81573141) 

Source(s) of funding:

the National Natural Science Foundation of China (No. 81573141) 

研究疾病:

无 

Target disease:

none 

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:

明确蔬菜菊苣酚酸类(没食子酸、原儿茶酸、咖啡酸、菊苣酸、绿原酸)和倍半萜类(莴苣苦素、8-脱氧山莴苣素、山莴苣苦素、11β,13-二氢山莴苣苦素、山莴苣苦素甲酯、苦苣菜苷 C 苷元、木兰属内酯、菊苣内酯 A)化合物在健康成年人的生物利用度。 

Objectives of Study:

Find out the bioavailability of Chicory phenolic acids and sesquiterpenoids in Humans. The components of phenolic acids contain gallic acid, echinotelic acid, coffee acid, chicory acid and chlorogenic acid. The components of sesquiterpenoids contain lettuce bitter element, 8-deoxidizing the mountains lettuce element, lettuce bitter, 11β, 13 - dihydro methyl mountain lettuce hard element, mountain lettuce element, bitter radicchio dishes glycosides C glycosides yuan, magnolias lactone and chicory lactones A. 

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:

18~59岁健康成年人;正常体重;不吸烟;不嗜酒;无冠心病、心肌梗塞、脑中风、脂肪肝、肝炎、肝硬化、慢性肾小球肾炎、肾盂肾炎、肾病综合征、肾结石、胃炎、肠炎、胃溃疡、肠溃疡、胆囊炎、胆管炎、便秘、糖尿病、药物过敏史和神经系统疾病史。  

Inclusion criteria

Healthy adults aged 18 to 59 years; No smoking; No alcohol; Without coronary heart disease, myocardial infarction, stroke, fatty liver, hepatitis, cirrhosis, chronic pyelonephritis, glomerulonephritis, nephrotic syndrome, kidney stones, enteritis, gastritis, gastric ulcer, duodenal ulcer, cholecystitis, cholangitis, constipation, diabetes, the history of drug allergy or history of neurological disease. 

排除标准:

试验前3个月内接受抗生素治疗、酚酸类和倍半萜类化合物膳食补充剂。 

Exclusion criteria:

Antibiotic treatment, phenolic acids and sesquiterpene dietary supplements were received within 3 months before the trial. 

研究实施时间:

Study execute time:

From2017-11-01To 2018-05-01 

征募观察对象时间:

Recruiting time:

From2018-01-01To 2018-02-01 

干预措施:

Interventions:

组别:

Case series

样本量:

16

Group:

Case series

Sample size:

干预措施:

饮用菊苣汁

干预措施代码:

Intervention:

Drinking vegetable juice

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

广东省第二人民医院 

单位级别:

三级甲等 

Institution
hospital:

Guangdong Second Provincial General Hospital  

Level of the institution:

Tertiry A Hospital 

测量指标:

Outcomes:

指标中文名:

酚酸类化合物

指标类型:

主要指标 

Outcome:

phenolic acids

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

倍半萜类化合物

指标类型:

主要指标 

Outcome:

sesquiterpenes

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:

尿液

组织:

Sample Name:

urine

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

组织:

Sample Name:

faeces

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 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):

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

none

盲法:

Blinding:

是否共享原始数据:

IPD sharing

是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):

实验结果数据随文章内发表

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

the experiment result data published in the article

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:

原始记录保存于纸质版,电子数据使用EXCEL管理

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

The original record is stored in the paper, and the electronic data is managed by EXCEL

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-01-10
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