ChiCTR2000035138 版本V1.2 版本创建时间2020/8/2 0:29:16 中国临床试验注册中心

审核状态:

Project audit state:

通过审核

Successful

注册号:

Registration number:

ChiCTR2000035138 

最近更新时间:

Date of Last Refreshed on:

2020/8/2 0:23:05 

注册号状态:

预注册  

Registration Status:

Prospective registration  

填写语言:

中文和英文  

Language:

Chinese And English  

注册题目:

运动-营养干预促进健康的研究 

Public title:

Study on health promotion by exercise nutrition intervention 

注册题目简写:

 

Public title acronym:

 

研究课题的正式科学名称:

多中心运动-营养干预促进健康的中国方案 

Scientific title:

Exercise-nutrition intervention for health promotion in China: a multicenter study 

研究课题的正式科学名称简写:

 

Scientific title acronym:

 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

廖八根 

研究负责人:

胡敏 

Applicant:

Liao Bagen 

Study leader:

Hu Ming 

申请注册联系人电话:

Applicant telephone:

+86 13527602478 

研究负责人电话:

Study leader's telephone:

+86 20-38027669 

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:

bagen2015@163.com 

研究负责人电子邮件:

Study leader's E-mail:

whoomin@aliyun.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:

广州省广州市天河区广州大道中1268号 

研究负责人通讯地址:

广州省广州市天河区广州大道中1268号 

Applicant address:

1268 Middle Guangzhou Avenue, Tianhe District, Guangzhou, Guangdong, China 

Study leader's address:

1268 Middle Guangzhou Avenue, Tianhe 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:

广州体育学院 

Applicant's institution:

Guangzhou Sport 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:

2020LCLL-003 

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:

广州体育学院伦理审查委员会 

Name of the ethic committee:

Human Experimental Ethics Inspection of Guangzhou Sport University  

伦理委员会批准日期:

Date of approved by ethic committee:

2020-05-11 

国家FDA批准文号:

Approved No. of SFDA:

国家FDA批准附件:

Approved file of SFDA:

国家FDA批准日期:

Date of approved by SFDA:

研究实施负责(组长)单位:

广州体育学院 

Primary sponsor:

Guangzhou Sport University  

研究实施负责(组长)单位地址:

广州省广州市天河区广州大道中1268号 

Primary sponsor's address:

1268 Guangzhou Avenue, 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

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广州体育学院

具体地址:

天河区广州大道中1268号

Institution
hospital:

Guangzhou Sport University

Address:

1268 Middle Guangzhou Avenue, Tianhe District

经费或物资来源:

国家重点研发计划 2020YFC2002904 

Source(s) of funding:

national key research and development plan 

研究疾病:

健康人、高血压、糖尿病、肥胖、营养不良 

Target disease:

Hypertension, Diabetes, Obese, Undernutrition 

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:

构建有效的社区营养-运动干预模式。 (1)运动结合NMN补充对心肺耐力影响。 (2)运动-营养联合干预模式对不同慢病(高血压、糖尿病、肥胖、营养不良)中老年的健康影响。 

Objectives of Study:

To construct an effective community nutrition exercise intervention model. 1. Exercise combined with NMN supplementation has an effect on cardiopulmonary endurance. 2. Exercise nutrition combined intervention mode has an impact on the health of middle-aged and elderly people with different chronic diseases (hypertension, diabetes, obesity, malnutrition). 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1)40岁以上本区常住居民,有较好的依从性并签署知情同意书。 2)自愿参与实验。 3)运动和营养风险评估筛选为中低风险的。 

Inclusion criteria

1. Residents over 40 years old in this district have good compliance and sign informed consent; 2. The subjects who participated in the experiment voluntarily; 3. The subjects with low and medium risk were screened by exercise and nutrition risk assessment. 

排除标准:

1)有严重听说障碍,不能理解该研究目的、内容者。 2)重要脏器(心、肺、肾等)功能严重障碍者; 4)其他原因不能安全参与评估者; 5)无法完成评估报告或遵守本研究要求者; 

Exclusion criteria:

1. There are serious listening and speaking barriers and can't understand the object of the research purpose and content; 2. Objects with serious dysfunction of vital organs (heart, lung, kidney, etc.); 3. The objects that cannot participate in the assessment safely due to other reasons; 4. Those who are unable to complete the evaluation report or comply with the requirements of this study. 

研究实施时间:

Study execute time:

From2020-08-01To 2023-07-01 

干预措施:

Interventions:

组别:

对照组(高血压病)

样本量:

300

Group:

control group (Hypertension)

Sample size:

干预措施:

无干预

干预措施代码:

Intervention:

No intervention

Intervention code:

组别:

试验组组(高血压病)

样本量:

300

Group:

experimental group (Hypertension)

Sample size:

干预措施:

运动-营养干预

干预措施代码:

Intervention:

Exercise combined with nutrition intervention

Intervention code:

组别:

对照组(2型糖尿病)

样本量:

300

Group:

control group (2-DM)

Sample size:

干预措施:

无干预

干预措施代码:

Intervention:

No intervention

Intervention code:

组别:

试验组(2型糖尿病)

样本量:

300

Group:

experimental group (2-DM)

Sample size:

干预措施:

运动-营养干预

干预措施代码:

Intervention:

Exercise combined with nutrition intervention

Intervention code:

组别:

对照组(营养不良)

样本量:

300

Group:

control group (undernutrition)

Sample size:

干预措施:

无干预

干预措施代码:

Intervention:

No intervention

Intervention code:

组别:

试验组组(营养不良)

样本量:

300

Group:

experimental group (undernutrition)

Sample size:

干预措施:

运动-营养干预

干预措施代码:

Intervention:

Exercise combined with nutrition intervention

Intervention code:

组别:

对照组(肥胖)

样本量:

300

Group:

control group (obese)

Sample size:

干预措施:

无干预

干预措施代码:

Intervention:

No intervention

Intervention code:

组别:

试验组(肥胖)

样本量:

300

Group:

experimental group (obese)

Sample size:

干预措施:

运动-营养干预

干预措施代码:

Intervention:

Exercise combined with nutrition intervention(obese)

Intervention code:

组别:

对照组(健康人)

样本量:

10

Group:

control group

Sample size:

干预措施:

仅运动训练

干预措施代码:

Intervention:

only exercise

Intervention code:

组别:

试验组 (健康人)

样本量:

30

Group:

experimental group (healthy person)

Sample size:

干预措施:

运动训练同时补充不同剂量NMN补充组

干预措施代码:

Intervention:

Exercise training combined with different dosage of NMN supplem (low dosage, medium, high dosage)

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):

广州市疾病控制中心 

单位级别:

N/A 

Institution
hospital:

Guangzhou Center for Disease Control  

Level of the institution:

N/A 

测量指标:

Outcomes:

指标中文名:

简易体能测试

指标类型:

主要指标 

Outcome:

short physical performance battery

Type:

Primary indicator 

测量时间点:

干预前、干预后3、6月

测量方法:

Measure time point of outcome:

before intervention, 3 months, 6 months after intervention

Measure method:

指标中文名:

健康指数量表

指标类型:

主要指标 

Outcome:

EQ-5D

Type:

Primary indicator 

测量时间点:

干预前、干预后3、6月

测量方法:

Measure time point of outcome:

before intervention, 3 months, 6 months after intervention

Measure method:

指标中文名:

生理生化参数(血压、血糖、血脂等)

指标类型:

主要指标 

Outcome:

blood pressure,serum lipid,blood glucose etc

Type:

Primary indicator 

测量时间点:

干预前、干预后3、6月

测量方法:

Measure time point of outcome:

before intervention, 3 months, 6 months after intervention

Measure method:

指标中文名:

症状自评量表SCL-90

指标类型:

次要指标 

Outcome:

SCL-90

Type:

Secondary indicator 

测量时间点:

干预前、干预后3、6月

测量方法:

Measure time point of outcome:

before intervention, 3 months, 6 months after intervention

Measure method:

指标中文名:

心肺耐力

指标类型:

主要指标 

Outcome:

cardiopulmonary endurance

Type:

Primary indicator 

测量时间点:

运动结合NMN补充前后

测量方法:

CPET

Measure time point of outcome:

before and after NMN supplement

Measure method:

CPET

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

使用后保存 

说明

Fate of sample:

Preservation 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:

征募研究对象情况:

Recruiting status:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 40 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):

随机方法采用随机数字表法。

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

The random sequence will be gengered by using random number table.

UTN(全球唯一识别码):

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

Organizer institution (leader institution):

资料收集汇总单位:

6M

Data collection Institution:

资料管理单位:

试验完成后6个月内公开;与研究负责人联系

Data management Institution:

Open to the public within 6 months of completion of the trial; contact with research director of this trial

资料分析单位:

病例记录表

Data analysis Institution:

CRF

注册人:

Name on Registration:

 2020-08-01