ChiCTR2400085491 版本V1.0 版本创建时间2024/06/08 21:56:25 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：

ChiCTR2400085491 

最近更新日期：

Date of Last Refreshed on：

2024-06-08 21:55:48 

注册时间：

Date of Registration：

2024-06-08 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

轻度认知障患者抗炎饮食方案的构建与实证研究

Public title：

Construction and empirical study of an anti-inflammatory dietary regimen for patients with mild cognitive impairment

注册题目简写：

English Acronym：

研究课题的正式科学名称：

轻度认知障患者抗炎饮食方案的构建与实证研究

Scientific title：

Construction and empirical study of an anti-inflammatory dietary regimen for patients with mild cognitive impairment

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：

邱琳琳 

研究负责人：

陈丽丽 

Applicant：

Linlin Qiu 

Study leader：

Lili Chen 

申请注册联系人电话：

Applicant telephone：

+86 187 5071 5706

研究负责人电话：

Study leader's telephone：

+86 158 6081 6909

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：

1219641911@qq.com

研究负责人电子邮件：

Study leader's E-mail：

qzliy2006@fjmu.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：

福建省福州市台江区交通路88号福建医科大学

研究负责人通讯地址：

福建省福州市鼓楼区东街134号

Applicant address：

Fujian Medical University, No. 88, Jiaotong Road, Taijiang District, Fuzhou City, Fujian Province, China

Study leader's address：

No. 134, East Street, Gulou District, Fuzhou City, Fujian Province, 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：

福建医科大学

Applicant's institution：

Fujian Medical University

研究负责人所在单位：

福建省立医院

Affiliation of the Leader：

Fujian Provincial Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

K2024-02-011

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：

福建省立医院伦理委员会

Name of the ethic committee：

Ethics Committee of Fujian Provincial Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2024-02-25 00:00:00

伦理委员会联系人：

练发杨

Contact Name of the ethic committee：

Fayang Lian

伦理委员会联系地址：

福建省福州市鼓楼区东街134号

Contact Address of the ethic committee：

No. 134, East Street, Gulou District, Fuzhou City, Fujian Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 591 8821 6023

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：

福建省立医院

Primary sponsor：

Fujian Provincial Hospital

研究实施负责（组长）单位地址：

福建省福州市鼓楼区东街134号

Primary sponsor's address：

No. 134, East Street, Gulou District, Fuzhou City, Fujian Province, 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)：

福建省

市(区县)：

福州市

Country：

China

Province：

Fujian

City：

Fuzhou

单位(医院)：

福建省立医院

具体地址：

福建省福州市鼓楼区东街134号

Institution
hospital：

Fujian Provincial Hospital

Address：

No. 134, East Street, Gulou District, Fuzhou City, Fujian Province, China

经费或物资来源：

福建医科大学研究生课题经费

Source(s) of funding：

Funding for Graduate Student Projects at Fujian Medical University

Target disease：

Mild cognitive impairment

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

构建适用于MCI人群的抗炎饮食方案；评价抗炎饮食方案在MCI人群中的应用效果  

Objectives of Study：

Constructing an anti-inflammatory dietary regimen for the MCI population; evaluating the effectiveness of the anti-inflammatory dietary regimen in the MCI population

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

①年龄≥60 岁；②符合AD源性MCI的诊断标准并结合病史、实验室检查等资料由临床神经内科医师确诊；③经中国半定量食物评率问卷（Food frequency questionnarire, FFQ）评估计算个体DII≤0；④能用普通话沟通交流，可在指导下独立完成量表测评；⑤未参与其他饮食干预研究；⑥无自我报告的视觉、听觉障碍；⑦参与者及家属知情同意且自愿参与本研究，并签署知情同意书

Inclusion criteria

Participants were ≥60 years old; ② met the diagnostic criteria for AD-derived MCI and were diagnosed by a clinical neurologist in conjunction with medical history and laboratory tests; ③ had an individual DII ≤0 as assessed by the Chinese semiquantitative food frequency questionnarire (FFQ) ; ④ were able to communicate in Mandarin and complete the scale independently; ⑤ had not participated in other dietary intervention studies; ⑥ did not have self-reported visual or auditory impairment; ⑦ participants and their families gave informed consent and voluntarily participated in this study; ⑦ participants and their families signed an informed consent form. (iv) Able to communicate in Mandarin and complete the scale independently under guidance; (v) Not participating in other dietary intervention studies; (vi) No self-reported visual or auditory impairment; (vii) Participants and their families gave informed consent to voluntarily participate in this study and signed an informed consent form.

排除标准：

①患有酒精中毒史、药物成瘾史，或脑外伤、脑血管疾病、脑炎及癫痫等可能引起认知障碍的神经系统疾病；②既往或现在正在应用改善认知的相关药物（如胆碱酯酶抑制剂、兴奋性氨基酸受体拮抗剂等）；③既往或现在正在服用可引起机体炎症水平变化药物；④患有严重躯体性疾病（如精神障碍、生命终末期）无法完成饮食干预；⑤已经参与其他影响认知功能的临床试验

Exclusion criteria：

(i) have a history of alcoholism, drug addiction, or neurological diseases such as traumatic brain injury, cerebrovascular disease, encephalitis, and epilepsy that may cause cognitive disorders; (ii) have been or are currently applying medications related to improving cognition (e.g., cholinesterase inhibitors, excitatory amino acid receptor antagonists, etc.); (iii) have been or are currently taking medications that can cause changes in the level of inflammation in the body; (iv) suffer from a serious somatic illness (e.g., psychiatric disorders, end-of-life) that prevents them from completing the dietary interventions; and (v) have already been involved in other clinical trials that affect cognitive function.

研究实施时间：

Study execute time：

从 From 2024-02-26 00:00:00至 To 2024-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-06-12 00:00:00 至 To 2024-09-30 00:00:00  

干预措施：

Interventions：

组别：

对照组

样本量：

35

Group：

control subjects

Sample size：

干预措施：

（1）为患者发放MCI健康知识手册以供患者学习；并每个月召开一次线下健康知识讲座； （2）为患者发放饮食饮食记录表供患者进行每日饮食记录； （3）为患者建立微信群，在群内进行随机问答，督促患者进行每日三餐饮食记录，提升患者依从性； （4）干预周期结束后为患者进行认知功能测试及血清炎症指标检测； （5）干预结束后，进行为期12周的随访，随访结束后为患者进行认知功能测试、膳食评估以及血清炎症指标检验。

干预措施代码：

Intervention：

(1) Distribute MCI health literacy brochures for patients to study; and hold offline health literacy seminars once a month; (2) Distribute dietary record sheets for patients to record their daily diets; (3) Establishing a WeChat group for patients and conducting randomized Q&A sessions in the group to urge patients to record their daily diets and improve patient compliance; (4) Cognitive function test and serum inflammation index test were conducted for patients at the end of the intervention cycle; (5) After the intervention, a 12-week follow-up was conducted, after which the patients were given cognitive function tests, dietary assessments, and serum inflammatory index tests.

Intervention code：

组别：

试验组

样本量：

35

Group：

intervention group

Sample size：

干预措施：

（1）为试验组患者发放抗炎饮食方案指导手册，手册内容包含认知促进食物推荐表、具备抗炎潜能的饮食元素和饮食方案介绍，并在研究患者入组时为每位患者进行一对一饮食培训，学习如何进行食物选择；嘱患者每日三餐根据抗炎饮食推荐表进行食物选择，并根据食物克重换算图记录食物摄入量，于手册内附饮食记录表记录每日三餐饮食情况，为期12周； （2）为患者发放MCI健康知识手册以供患者学习；并每个月召开一次线下健康知识讲座； （3）为患者建立微信群，在群内进行随机问答，并督促患者将三餐饮食及每日饮食记录表拍照上传至微信群，并为依从性最高的患者及饮食管理效果最佳的患者设立奖励机制，以提高患者积极性； （4）为期12周的干预周期结束后，为患者测试认知功能及血清炎症指标检验； （5）干预结束后，进行为期12周的随访，随访结束后为患者进行认知功能测试、膳食评估以及血清炎症指标检验。

干预措施代码：

Intervention：

(1) An anti-inflammatory dietary regimen guidebook containing a list of recommended cognitive-enhancing foods, dietary elements with anti-inflammatory potential, and a description of the dietary regimen was distributed to patients in the trial group, and one-on-one dietary training was provided to each patient at the time of enrollment in order to learn how to make food choices; patients were instructed to make their food choices according to the anti-inflammatory dietary regimen for three meals per day and to record food intake according to the food gram-forgram conversion charts. Patients were instructed to make food choices according to the recommended anti-inflammatory diet and to record food intake according to the food gram-weight conversion chart for three meals per day, and the dietary record sheet was attached to the manual to record the dietary situation of the three meals per day for 12 weeks; (2) Distribute MCI health knowledge brochures for patients to learn; and hold offline health knowledge seminars once a month; (3) Establishing a WeChat group for patients, conducting randomized question and answer sessions, and urging patients to take photos of their three-meal diets and daily dietary record sheets and upload them to the WeChat group, as well as setting up an incentive mechanism for the patients with the highest adherence rate and the best dietary management results to improve patient motivation; (4) At the end of the 12-week intervention cycle, patients were tested for cognitive function and serum inflammatory index tests; (5) At the end of the 12-week intervention period, patients were followed up with cognitive function tests, dietary assessments, and serum inflammatory tests.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 福建 

市(区县)：

 福州 

Country：

China 

Province：

Fujian 

City：

Fuzhou 

单位(医院)：

福建省立医院 

单位级别：

三甲 

Institution
hospital：

Fujian Provincial Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

认知功能及各认知领域功能

指标类型：

主要指标

Outcome：

cognitive function

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血清炎症指标

指标类型：

次要指标

Outcome：

Serum Inflammatory Indicators

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：

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 60 岁 years
最大 Max age 85 岁 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）：

使用随机数字序列由不直接参与本研究的人员在Research Randomizer（http://www.randomizer.org/）网站上生成，将这些随机数字按大小排序，前半部分为干预组，后半部分为对照组。

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

Using a sequence of random numbers generated on the Research Randomizer (http://www.randomizer.org/) website by people not directly involved in this study, these random numbers were ordered by size, with the first half being the intervention group and the second half being the control group.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

由于饮食干预需明确告知患者如何具体执行，故较难对干预者和研究对象实施盲法。考虑到本研究的结局指标测评具有一定的主观性，本研究拟对调查员设盲，嘱研究对象在测评过程中不对调查员透露自己的分组情况。

Blinding：

Since the dietary intervention needs to be clearly communicated to patients on how to implement it, it is more difficult to blind the interventionist and the study subjects. Considering the subjective nature of the outcome indicator measures in this study, it is proposed that the investigator be blinded in this study, and the study participants are instructed not to disclose their subgroups to the investigator during the assessment process.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

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）：

我们将以论文的形式公布试验方案，有需要原始数据的科研工作者可以通过联系通讯作者获取。

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

web-based public database, please provide the url): We will publish the experimental protocol in the form of a paper, and researchers who need the raw data can obtain it by contacting the corresponding author.

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：

由经过专门培训的资料收集员对数据进行测量和采集。采用Excel 2016建立数据库,为保证数据录入的准确性，所有数据均双人录入；采用SPSS软件进行数据处理。

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

Data are measured and collected by the professional training nurses; the database is established using excel 2016, and then to ensure the accuracy of data, all data is entered by two researchers; SPSS will be used for data analysis.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2024-06-08 21:55:48