Today is 2021-04-21

Water-soluble tomato extract improves platelet function in subjects with metabolic syndrome: a randomized clinical trial
download

注册号:

Registration number:

ChiCTR2000040559 

最近更新日期:

Date of Last Refreshed on:

2021-03-08 

注册时间:

Date of Registration:

2020-12-02 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

水溶性番茄浓缩物改善代谢综合征患者血小板功能的人群干预研究 

Public title:

Water-soluble tomato extract improves platelet function in subjects with metabolic syndrome: a randomized clinical trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

水溶性番茄浓缩物改善代谢综合征患者血小板功能的摄入量-效应关系研究 

Scientific title:

Dose-response effects of water-soluble tomato extract on platelet function in subjects with metabolic syndrome: a randomized clinical trial 

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:

李孔耀 

研究负责人:

杨燕 

Applicant:

Li Kongyao 

Study leader:

Yan Yang 

申请注册联系人电话:

Applicant telephone:

+86 17825013856 

研究负责人电话:

Study leader's telephone:

+86 20 87330687 

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:

liky33@mail2.sysu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

yangyan3@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:

广东省广州市番禺区外环东路132号 

研究负责人通讯地址:

广东省广州市番禺区外环东路132号 

Applicant address:

132 East Outer Ring Road, Guangzhou, Guangdong, China 

Study leader's address:

132 East Outer Ring Road, 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:

中山大学公共卫生学院(深圳) 

Applicant's institution:

School of Public Health (Shenzhen), 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:

中大公卫(深圳)医伦〔 2020 ) 第 044 号 

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:

中山大学公共卫生学院(深圳)伦理委员会 

Name of the ethic committee:

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

伦理委员会批准日期:

Date of approved by ethic committee:

2020-10-13 

伦理委员会联系人:

舒跃龙 

Contact Name of the ethic committee:

Shu yuelong 

伦理委员会联系地址:

广东省广州市番禺区外环东路132号 

Contact Address of the ethic committee:

132 East Outer Ring Road, 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:

中山大学公共卫生学院(深圳) 

Primary sponsor:

School of Public Health (Shenzhen), Sun Yat-sen University 

研究实施负责(组长)单位地址:

广东省广州市番禺区外环东路132号 

Primary sponsor's address:

132 East Outer Ring Road, Guangzhou, Guangdong, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

汤臣倍健股份有限公司 

Source(s) of funding:

BY-HEAITH CO.,LTD 

研究疾病:

代谢综合征 

Target disease:

metabolic syndrome 

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:

代谢综合征是CVD的多重危险因素。代谢综合征诱导的血小板高反应性在CVD的病理过程中发挥重要作用。研究发现水溶性番茄浓缩物可抑制体外及健康人血小板聚集和活化。然而,水溶性番茄浓缩物对代谢综合征患者血小板功能的影响尚不清楚。本研究拟通过人体实验,探讨水溶性番茄浓缩物对代谢综合征患者血小板功能的改善作用及其量-效反应关系. 

Objectives of Study:

Metabolic syndrome induced platelet hyper-activation and hyper-aggregation, which plays an important role in the pathological process of CVD. Water-soluble tomato extract can inhibit platelet activation and aggregation in vitro and in healthy adult. However, the effect of water-soluble tomato extract on platelet function in subjects with metabolic syndrome are unclear. The present study intends to investigate the effect of water-soluble tomato extract on platelet function and dose-response in individual with metabolic syndrome. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

不同剂量对照 

Study design:

Dose comparison 

纳入标准:

1) 年龄 35-70 岁; 2) 参考《中国 2 型糖尿病防治指南 2017》 中代谢综合征的诊断标准,具备以下三项或以上即可: (1) 腹型肥胖(即中心型肥胖): 腰围男性≥90 cm, 女性≥85cm。 (2) 高血糖: 空腹血糖≥6.1mmol/L 或糖负荷后 2h 血糖≥7.8mmol/L。 (3) 高血压: 收缩压≥130mmHg 和(或) 舒张压≥85mmHg。 (4) 空腹 TG≥1.70mmol/L。 (5) 空腹 HDL-C<1.04mmol/L。 3) 签署知情同意书并坚持参加研究。 

Inclusion criteria

1) Aged 35-70 years old; 2) According to the diagnostic criteria of metabolic syndrome in the "Chinese Type 2 Diabetes Prevention Guidelines 2017", and three or more of following are acceptable: (1) Abdominal obesity (central obesity): waist circumference >=90 cm for men and >=85cm for women; (2) Hyperglycemia: fasting blood glucose >=6.1mmol/L or 2h after glucose load >=7.8mmol/L; (3) Hypertension: systolic blood pressure >=130mmHg and (or) diastolic blood pressure >=85mmHg; (4) Fasting TG>=1.70mmol/L; (5) Fasting HDL-C<1.04mmol/L; 3) Sign informed consent and insist on participating in the research. 

排除标准:

1) 现在正服用或近半年内曾服用降压药、 降脂药、 降糖药或使用胰岛素治疗; 2) 近两个月服用其他影响血小板功能的药物/膳食营养补充剂, 如阿司匹林、 鱼油等; 3) 明显的血管或血液系统疾病或感染; 4) 血压≥160/100mmHg; 5) 血小板计数较低(全血<100 x 109/ mL); 6) 血红蛋白异常(男性<120g/L, 女性<110g/L); 7) 红细胞压积较低(男性<40%, 女性<37%); 8) 凝血酶原时间(PT) 在正常参考值范围之外; 9) 孕妇及乳母; 10) 月经周期异常, 服用避孕药或激素替代疗法; 11) 胃溃疡, 肝肾功能不全者; 12)对番茄及其成分过敏者。 

Exclusion criteria:

1) Antihypertensive drugs, lipid-lowering drugs, hypoglycemic drugs or insulin therapy was used in recently six months; 2) Take drugs/dietary supplements, such as aspirin, fish oil and etc., that affect platelet function in recently two months; 3) blood system disease or infection; 4) Blood pressure >=160/100mmHg; 5) Low platelet count (whole blood platelet<100 x 10^9/mL); 6) Abnormal hemoglobin (male <120g/L, female <110g/L); 7) Low hematocrit (male <40%, female <37%); 8) Prothrombin time (PT) is outside the normal reference range; 9) Pregnant women or nursing mothers; 10) Abnormal menstrual cycle, taking birth control pills or hormone replacement therapy; 11) Gastric ulcer, liver or kidney dysfunction; 12) Allergic to tomatoes or its ingredients. 

研究实施时间:

Study execute time:

From2020-12-01To 2022-12-31 

征募观察对象时间:

Recruiting time:

From2021-01-01To 2021-09-30 

干预措施:

Interventions:

组别:

安慰剂组

样本量:

50

Group:

placebo group

Sample size:

干预措施:

口服安慰剂 600 mg/天

干预措施代码:

Intervention:

take orally 600 mg placebo per day

Intervention code:

组别:

150 mg/d水溶性番茄浓缩物干预组

样本量:

50

Group:

150mg / d water-soluble tomato extract intervention group

Sample size:

干预措施:

口服干预物600mg/天(包含150mg水溶性番茄浓缩物)

干预措施代码:

Intervention:

take orally 600 mg drug per day (contains 150mg water-soluble tomato extract)

Intervention code:

组别:

300 mg/d水溶性番茄浓缩物干预组

样本量:

50

Group:

150mg / d water-soluble tomato extract intervention group

Sample size:

干预措施:

口服干预物600mg/天(包含300mg水溶性番茄浓缩物)

干预措施代码:

Intervention:

take orally 600 mg drug per day (contains 300mg water-soluble tomato extract)

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广州省 

市(区县):

广州 

Country:

China 

Province:

Guangdong Province 

City:

Guangzhou 

单位(医院):

公共卫生学院(深圳) 

单位级别:

高等院校 

Institution
hospital:

School of Public Health (Shenzhen), Sun Yat-sen University  

Level of the institution:

university 

测量指标:

Outcomes:

指标中文名:

血小板聚集、活化

指标类型:

主要指标 

Outcome:

platelet aggregation and acativation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血小板颗粒释放物

指标类型:

主要指标 

Outcome:

Platelet granule release

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

凝血功能

指标类型:

次要指标 

Outcome:

Coagulation function

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 pressure

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血糖

指标类型:

次要指标 

Outcome:

Blood sugar

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 fat

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

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:

stool

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 35 years
最大 Max age 70 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):

项目负责人应用spss软件各组分别赋予志愿者随机数,再依据随机数排序,将各组内志愿者随机分配到水溶性番茄浓缩物组和安慰剂组

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

The project manager used spss software to assign volunteer random numbers to each group, and then ordered them according to random numbers. The volunteers in each group were randomly assigned to water-soluble tomato extract group and placebo group.

盲法:

Not stated

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

中山大学公共卫生学院(深圳)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(Shenzhen), 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:

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:

a CRF and an electronic data capture

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-12-02
return list