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口服营养补充对改善中国社区居住有营养不良风险老年人营养状态的效果评价
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注册号:

Registration number:

ChiCTR1900026784 

最近更新日期:

Date of Last Refreshed on:

2019-10-22 

注册时间:

Date of Registration:

2019-10-22 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

口服营养补充对改善中国社区居住有营养不良风险老年人营养状态的效果评价 

Public title:

Effect of oral nutritional supplement on improving nutritional status of elderly people with malnutrition risk in Chinese community 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

口服营养补充对改善中国社区居住有营养不良风险老年人营养状态的效果评价 

Scientific title:

Effect of oral nutritional supplement on improving nutritional status of elderly people with malnutrition risk in Chinese community 

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:

付萍 

研究负责人:

付萍 

Applicant:

Ping FU 

Study leader:

Ping Fu 

申请注册联系人电话:

Applicant telephone:

+86 13311178898 

研究负责人电话:

Study leader's telephone:

+86 13311178898 

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:

pingfu0222@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

pingfu0222@xinlang.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:

北京市东城区崇文门外大街9号正仁大厦8楼 

研究负责人通讯地址:

北京市东城区崇文门外大街9号正仁大厦8楼 

Applicant address:

8th Floor, Zhengren Building, 9 Chong-Wen-Men-Wai Street, Dongcheng District, Beijing, China 

Study leader's address:

8th Floor, Zhengren Building, 9 Chong-Wen-Men-Wai Street, Dongcheng District, Beijing, 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:

中国老年学和老年医学学会营养与食品分会 

Applicant's institution:

Chinese Society of Gerontology and Geriatrics Nutrition and Food Branch 

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:

2017-001 

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:

北京老年医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of Beijing Geriatric Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

田喜慧 

Contact Name of the ethic committee:

Xihui Tian 

伦理委员会联系地址:

北京市海淀区温泉路118号 

Contact Address of the ethic committee:

118 Wenquan Road, Haidian District, Beijing 

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:

中国 

Primary sponsor:

China 

研究实施负责(组长)单位地址:

北京市东城区崇文门外大街正仁大厦8楼 

Primary sponsor's address:

8th Floor, Zhengren Building, 9 Chong-Wen-Men-Wai Street, Dongcheng District, Beijing, 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):

东城区

Country:

China

Province:

Beijing

City:

Dongcheng District

单位(医院):

中国老年学和老年医学学会营养与食品分会

具体地址:

北京市东城区崇文门外大街正仁大厦8楼

Institution
hospital:

Chinese Society of Gerontology and Geriatrics Nutrition and Food Branch

Address:

8th Floor, Zhengren Building, 9 Chong-Wen-Men-Wai Street

经费或物资来源:

雅培(中国)公司 

Source(s) of funding:

Abbott (China) company 

研究疾病:

营养不良 

Target disease:

Malnutrition 

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:

由于营养不良在老年人群中高发,所以本研究旨在探索口服营养补充对有营养不良风险老年人的身体测量指标、营养状况和生活质量的影响。 

Objectives of Study:

The purpose of this study is to explore the effect of oral nutrition supplementation on the physical measurement, nutritional status and quality of life of the elderly at risk of malnutrition. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

①年龄≥60岁; ②性别不限; ③有营养不良风险(Short-Form Mini-Nutritional Assessment (MNA-SF)评分<12分和或Body Mass Index (BMI) < 25 kg/m2); ④受试者能自主行走; ⑤签署知情同意书。 

Inclusion criteria

1. aged >= 60 years old; 2. gender unlimited; 3. short form Mini Nutritional Assessment (MNA-SF) score < 12 and body mass index (BMI) < 25 kg / m2); 4. subjects can walk autonomously; 5. sign informed consent. 

排除标准:

①身体残疾,体内植入电子、金属设备者; ②患有消化、代谢系统疾病; ③患有活动性结核病(TB)、病毒性肝炎或HIV感染等传染疾病; ④确诊为癌症等消耗性疾病患者; ⑤有严重痴呆或神智不清、进食障碍、严重精神障碍史,或者存在其他可能影响摄入干预制剂者; ⑥在研究期间内口服除全安素以外的蛋白粉或中老年人奶粉类型的营养补充; ⑦对干预制剂过敏者。 

Exclusion criteria:

1. the person with physical disability and implanted electronic and metal equipment; 2. the person with digestive and metabolic system diseases; 3. the person with active tuberculosis (TB), viral hepatitis or HIV infection and other infectious diseases; 4. the person diagnosed with consumptive diseases such as cancer; 5. the person with severe dementia or mental confusion, eating disorder or severe mental disorder, or other intervention preparations that may affect the intake. During the study period; 6. the patients took protein powder or milk powder of middle-aged and old people except for Quanan; 7. the patients were allergic to the intervention preparation. 

研究实施时间:

Study execute time:

From2017-09-01To 2017-11-30 

干预措施:

Interventions:

组别:

干预组

样本量:

160

Group:

Case series

Sample size:

干预措施:

口服营养补充

干预措施代码:

Intervention:

Oral nutrition supplement

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

海淀区 

Country:

China 

Province:

Beijing 

City:

Haidian District 

单位(医院):

北京老年医院 

单位级别:

三级甲等医院 

Institution
hospital:

Beijing Geriatric Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

朝阳区 

Country:

China 

Province:

Beijing 

City:

Chaoyang District 

单位(医院):

北京邻家护理站 

单位级别:

 

Institution
hospital:

Beijing Neighboring Care Station  

Level of the institution:

 

测量指标:

Outcomes:

指标中文名:

体重

指标类型:

主要指标 

Outcome:

Weight

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

身体体质指数BMI

指标类型:

主要指标 

Outcome:

BMI

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

MNA-SF评分

指标类型:

次要指标 

Outcome:

MNA-SF score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

小腿围

指标类型:

次要指标 

Outcome:

Calf girth

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

握力

指标类型:

次要指标 

Outcome:

Grip

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

6米步速

指标类型:

次要指标 

Outcome:

6 meters pace

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量评分

指标类型:

次要指标 

Outcome:

Short Form-36

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

骨骼肌质量

指标类型:

次要指标 

Outcome:

Skeletal muscle mass

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

脂肪量

指标类型:

次要指标 

Outcome:

Fat mass

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

瘦体重

指标类型:

次要指标 

Outcome:

Soft lean mass

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

膳食摄入

指标类型:

次要指标 

Outcome:

Dietary intake

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

身高

指标类型:

附加指标 

Outcome:

Height

Type:

Additional 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:

组织:

Sample Name:

No

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 60 years
最大 Max age 97 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):

N/A, 仅有干预组,未使用随机方法

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

N/A, Only intervention group, no random method

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/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):

临床研究电子管理公共平台 ResMan(http://www.medresman.org)

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

the Clinical Trial Public Management Platform ResMan(www.medresman.org)

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

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

Case Record Form, CRF

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2019-10-22
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