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A randomized controlled trial of 8week yoga training on circulating metabolic and inflammatory markers in healthy, Chinese female subjects
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注册号:

Registration number:

ChiCTR-IOR-14005747 

最近更新日期:

Date of Last Refreshed on:

2014-12-31 

注册时间:

Date of Registration:

2014-12-27 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

8周瑜伽训练对正常成年女性血液免疫指标的影响及机制探讨 

Public title:

A randomized controlled trial of 8week yoga training on circulating metabolic and inflammatory markers in healthy, Chinese female subjects 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

8周瑜伽训练对正常成年女性血液免疫指标的影响及机制探讨 

Scientific title:

A randomized controlled trial of 8week yoga training on circulating metabolic and inflammatory markers in healthy, Chinese female subjects 

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:

万忠晓 

研究负责人:

万忠晓 

Applicant:

Zhongxiao Wan 

Study leader:

Zhongxiao Wan 

申请注册联系人电话:

Applicant telephone:

+86 18362592783 

研究负责人电话:

Study leader's telephone:

+86 18362592783 

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:

zhxwan@suda.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

zhxwan@suda.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:

江苏省苏州市仁爱路199号 

研究负责人通讯地址:

江苏省苏州市仁爱路199号 

Applicant address:

199 Renai Road, Suzhou, China 

Study leader's address:

199 Renai Road, Suzhou, China 

申请注册联系人邮政编码:

Applicant postcode:

215123 

研究负责人邮政编码:

Study leader's postcode:

215123 

申请人所在单位:

苏州大学 

Applicant's institution:

Soochow 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:

2014-01 

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:

苏州大学伦理委员会 

Name of the ethic committee:

thics Committee of Soochow University 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-11-10 

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:

苏州大学 

Primary sponsor:

Soochow University 

研究实施负责(组长)单位地址:

江苏省苏州市仁爱路199号 

Primary sponsor's address:

199 Renai Road, Suzhou, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

苏州大学科研启动经费 

Source(s) of funding:

Start-up funding fro Soochow University 

研究疾病:

肥胖及免疫功能紊乱 

Target disease:

obesity and immune disorder 

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:

Other 

研究目的:

本课题拟:⑴ 探讨8周瑜伽训练对正常成年女性代谢性指标及内皮微颗粒的影响。⑵ 探讨8周瑜伽训练对正常成年女性的血清炎性细胞因子及脂多糖和Pam3Cys-SK4诱导的外周血培养IL-6、 IL-1β和TNF-α分泌的影响。 

Objectives of Study:

The aim of the present study is 1) to determine the effects of a 8 wk yoga training program on blood glucose, insulin, lipid profiles, and EMPs in healthy, lean and female Chinese subjects; 2) to determine the effects of a 8 wk yoga training program on inflammatory markers in the above subjects via measuring circulating cytokine levels, as well as LPS and Pam3Cys-SK4 (Pam) stimulated cytokines secretion in whole blood culture ex vivo. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照试验 

Study design:

Randomized parallel controlled trial 

纳入标准:

年龄:18-25周岁;18.5<体质指数<22.9 kg/m2;具有规律的月经周期(即每次月经周期在24-36天且在过去的12个月中周至少10次月经)。 

Inclusion criteria

Age18-25 years old; body mass index more than 18.5 and less than 22.9 kg/m2; self-reported regular menstrual cycles (i.e. cycle 24-36 days long and at least 10 cycles in the previous 12 months). 

排除标准:

在过去6个月中使用避孕药;患有乳腺癌、心脏病、糖尿病或其他严重疾病病史;患有其它骨骼系统疾病而不能够参与瑜伽锻炼。 

Exclusion criteria:

Use of pharmacologic contraceptives (past 6 months); history of breast cancer, heart diseases, diabetes mellitus, or other serious medical conditions; suffering from musculoskeletal conditions that would prevent participation in an yoga training. 

研究实施时间:

Study execute time:

From2015-01-15To 2015-05-01 

干预措施:

Interventions:

组别:

A

样本量:

15

Group:

A

Sample size:

干预措施:

8周瑜伽训练

干预措施代码:

Intervention:

8 wk yoga training program

Intervention code:

组别:

B

样本量:

15

Group:

B

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

空腹血糖

指标类型:

主要指标 

Outcome:

Fasting plasma glucose

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

空腹胰岛素

指标类型:

主要指标 

Outcome:

Fasting insulin

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

空腹血甘油三酯

指标类型:

主要指标 

Outcome:

fasting triacylglycerol

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

空腹血胆固醇、LDL及HDL-胆固醇

指标类型:

主要指标 

Outcome:

fasting total-cholesterol LDL-C HDL-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:

血浆内皮微颗粒

指标类型:

主要指标 

Outcome:

plasma endothelial microparticles

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血浆 IL-6, IL-8, IL-1β, MCP-1, TNF-α

指标类型:

主要指标 

Outcome:

IL-6, IL-8, IL-1beta, MCP-1, TNF-alpha

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

全血培养上清 IL-6, IL-1β, TNF-α分泌

指标类型:

主要指标 

Outcome:

IL-6, IL-1beta, TNF-alpha secretion from cultured whole blood

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

全血培养上清LPS及 Pam3Cys-SK4刺激的 IL-6, IL-1β, TNF-α分泌

指标类型:

主要指标 

Outcome:

IL-6, IL-1beta, TNF-alpha secretion from cultured whole blood stimulated with LPS and Pam3Cys-SK4

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:

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 18 years
最大 Max age 25 years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

由计算机产生的随机数字表由研究生进行随机分组。

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

Randomization was carried out via computer-generated random numbers while participants were not blin

盲法:

Blinding:

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:

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):

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

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:

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

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2014-12-27
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