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Trial search Nation, Province(City) Code of disease Primary sponsor(s) Secondary sponsor(s) Funding source Recruiting status Register status Measure Ethical committee Study type

Clinical Study on Comprehensive Nutritional Management for Gastric Cancer Patients

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注册号：

Registration number：

ChiCTR2500098607 

最近更新日期：

Date of Last Refreshed on：

2025-03-11 14:10:26 

注册时间：

Date of Registration：

2025-03-11 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

胃癌患者全程营养管理的临床研究

Public title：

Clinical Study on Comprehensive Nutritional Management for Gastric Cancer Patients

注册题目简写：

English Acronym：

研究课题的正式科学名称：

胃癌患者全程营养管理的临床研究

Scientific title：

Clinical Study on Comprehensive Nutritional Management for Gastric Cancer Patients

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：

李雪 

研究负责人：

张兰 

Applicant：

Xue L i 

Study leader：

Lan Zhang 

申请注册联系人电话：

Applicant telephone：

+86 138 9812 1192

研究负责人电话：

Study leader's telephone：

+86 185 0986 1969

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：

1106898292@qq.com

研究负责人电子邮件：

Study leader's E-mail：

18900918211@163.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：

辽宁省沈阳市大东区小河沿路44号

研究负责人通讯地址：

辽宁省沈阳市大东区小河沿路44号

Applicant address：

No. 44 Xiaoheyan Road, Dadong District, Shenyang City, Liaoning Province

Study leader's address：

No. 44 Xiaoheyan Road, Dadong District, Shenyang City, Liaoning Province

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：

辽宁省肿瘤医院

Applicant's institution：

Liaoning Cancer Hospital

研究负责人所在单位：

辽宁省肿瘤医院

Affiliation of the Leader：

Liaoning Cancer 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：

KY20230706

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：

辽宁省肿瘤医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Liaoning Cancer Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2023-07-04 00:00:00

伦理委员会联系人：

李爽

Contact Name of the ethic committee：

Shuang Li

伦理委员会联系地址：

辽宁省沈阳市大东区小河沿路44号

Contact Address of the ethic committee：

No. 44 Xiaoheyan Road, Dadong District, Shenyang City, Liaoning Provincel

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 180 4139 4699

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：

辽宁省肿瘤医院

Primary sponsor：

Liaoning Cancer Hospital

研究实施负责（组长）单位地址：

辽宁省沈阳市大东区小河沿路44号

Primary sponsor's address：

No. 44 Xiaoheyan Road, Dadong District, Shenyang City, Liaoning

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

辽宁

市(区县)：

Country：

China

Province：

Liaoning

City：

单位(医院)：

辽宁省肿瘤医院

具体地址：

辽宁省沈阳市大东区小河沿路44号

Institution
hospital：

Liaoning Cancer Hospital

Address：

No. 44 Xiaoheyan Road, Dadong District, Shenyang City, Liaoning

经费或物资来源：

中国初级卫生保健基金会

Source(s) of funding：

China Primary Health Care Foundation

Target disease：

Gastric cancer

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

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

（1）探讨全程化营养干预对围术期胃癌患者生活质量、心理、营养等相关指标的影响。 （2）提升胃癌患者营养KAP，旨在提高患者自我管理行为。 （3）通过不同频次收集实时行为数据，探讨有效的营养干预方式。  

Objectives of Study：

(1) To explore the impact of comprehensive nutritional intervention on quality of life, psychological status, nutritional status, and related indicators in gastric cancer patients. (2) To improve the nutrition-related knowledge, attitudes, and practices (KAP) of gastric cancer patients, with the aim of extending their survival duration. (3) To explore effective nutritional intervention methods by collecting real-time behavioral data at various frequencies.

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.病理诊断为胃腺癌患者；2.年龄在18-80周岁，能正确阅读和表达；3.存在营养风险的患者；4.知情同意，自愿参与。

Inclusion criteria

1. Patients with a pathological diagnosis of gastric adenocarcinoma; 2. Aged between 18 and 80 years, with the ability to read and express themselves correctly; 3. Patients who have nutritional risks; 4. Informed consent and voluntary participation.

排除标准：

1.有严重基础性疾病患者；2.胃肠功能障碍，不宜实施肠内营养的患者；3.含有严重血糖代谢紊乱患者；4.严重肝肾功能不全等患者。

Exclusion criteria：

1. Patients with severe underlying medical conditions; 2. Patients with gastrointestinal dysfunction who are not suitable for enteral nutrition; 3.Patients with severe blood glucose metabolism disorders; 4. Patients with severe liver or kidney insufficiency, among others.

研究实施时间：

Study execute time：

从 From 2024-03-01 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-03-25 00:00:00 至 To 2026-12-31 00:00:00  

干预措施：

Interventions：

组别：

对照组

样本量：

150

Group：

Control group

Sample size：

干预措施：

1.院内干预 给予常规营养治疗：①病情观察。严密观察患者病情变化情况，做好患者基础护理，及时发现并处理患者异常情况。合理控制患者药物剂量，以及饮食情况，指导患者进食后适当行走或站立。积极预防相关并发症的发生，根据症状的严重程度进行有效处理，最大限度地减轻患者的不适。②健康教育。护理人员在做好基础护理的同时，适当加强对患者的健康宣教，增强患者对疾病的认知度，从而提升其配合度。③饮食及用药干预。护理人员根据患者具体情况制定合理的进食方案。坚持少吃多餐的原则，指导患者正确饮食。叮嘱患者严格按照医嘱用药，并说明按时、按量用药的重要性。④口腔护理。给患者介绍口腔清洁的重要性，进餐前后可使用漱口水含漱，确保口腔清洁，减少口腔炎性反应发生。收集接受新辅助治疗患者用药前与术前资料，收集术前未治疗的手术患者基线资料。 2.院外干预 在出院前对患者和家属进行营养指导和宣教，在患者术后1个月、3个月进行回院复查或电话常规随访。

干预措施代码：

Intervention：

1.In-hospital Intervention Routine nutritional therapy was administered: ① Condition monitoring. Close observation of patients' condition changes, proper basic nursing care, timely detection and management of abnormalities. Rational control of medication dosages and dietary intake, with instructions given to patients to walk or stand appropriately after eating. Active prevention of related complications, with effective management based on the severity of symptoms to minimize patient discomfort. ② Health education. While providing basic nursing care, nurses appropriately enhanced health education for patients to enhance their understanding of the disease, thereby improving their cooperation. ③ Dietary and medication intervention. Nurses formulated reasonable dietary plans based on patients' specific conditions. Adhering to the principle of eating smaller meals more frequently, patients were guided on proper dietary habits. Patients were reminded to strictly follow medication instructions and informed of the importance of taking medications on time and in the correct dosage. ④ Oral care. Patients were educated on the importance of oral cleanliness, with mouthwash recommended before and after meals to ensure oral hygiene and reduce the occurrence of oral inflammation. Data was collected from patients receiving neoadjuvant therapy before medication and before surgery, as well as baseline data from surgical patients who did not receive preoperative treatment. 2.Out-of-hospital Intervention Nutritional guidance and education were provided to patients and their families before discharge, with routine follow-up visits scheduled for 1 and 3 months postoperatively, either in person or via telephone.

Intervention code：

组别：

试验组

样本量：

300

Group：

Experimental group

Sample size：

干预措施：

1.院内营养干预措施实验组在对照组的基础上，加强标准化营养干预和心理护理干预，具体内容如下： （1）小组成立 成立课题小组，其中消化道内外科主任2人，医生8人、营养师1人，护士长1人，营养护士2人（具有相应资格证）、责任护士7人、科研人员3人、随访专员1人、心理治疗师1人等组成的多学科团队。记录入组患者基本信息、人体测量指标、实验室指标、营养认知情况、心理状况、生活质量，建立“个人营养档案”。 （2）人员培训 课题小组成员经过统一肿瘤营养疗法培训，主要由医生和营养师进行，培训内容包括所涉及各种量表的使用、人员分工、医护人员营养认知。合格人员要求能够熟练应用自己负责的项目，使评估和干预做到同质化。（3）营养、护理相结合进行营养管理 ①营养支持。患者入院后给予营养素进行营养支持，其中能耐受口服营养的患者首选口服营养补充（oral nutritional supplements ,ONS),其次再考虑管饲肠内营养。由营养专科护士对存在营养风险的患者进行PG-SGA评分，营养师根据PG-SGA评分及患者自身身体状况负责制定营养计划，针对胃癌不同治疗方式，制定相应营养管理方案，每周评估患者体重、PG-SGA评分，结合发现的问题和患者需求进行适当调整。主治医师根据患者营养情况及病情状况下达医嘱，责任护士落实营养发展计划，记录临床研究资料，对患者和家属进行个体化健康教育。②心理护理。根据《中国肿瘤心理临床实践指南2020》，首先对患者进行认知行为干预，医护人员经常与患者及家属沟通，向患者普及疾病相关知识，如发病机制、治疗方法、不良反应以及注意事项等，增强患者对疾病的认知，提高患者知信行，鼓励患者在治疗过程中参与一些轻松有意义的活动，提升患者对疾病管理的主观积极需求，积极参与治疗，增强患者依从性。其次，护理人员及时了解患者心理状况，针对性进行疏导，结合心理辅导教育，通过文字、视频、图片、影像等方法对患者进行心理辅导等方式改善心理状况。主动询问患者身体状况，给患者介绍成功案例，增强信心，鼓励家属给予患者关爱和支持，增强患者家庭归属感。③康复运动：术前鼓励患者进行有氧运动，术后6h指导患者在床上轻微活动，如踝部屈伸等；术后24h开始离床活动，鼓励患者下地活动[21]，术后第3天适当增加运动量，走廊设立地标尺，根据患者活动能力设立每日步行路程目标，进食前15分钟活动，进食后30分钟活动，促进胃肠蠕动，每日使用握力器训练，每次握力持续时间5秒钟，时间连续握20个为一组，一天练习5组。患者刚练习时可以遵循循序渐进的原则，避免出现肌肉拉伤。 营养管理全程由科主任及护士长进行质控管理，主治医师负责处理患者营养治疗过程出现的病情变化，科研护士录入数据并进行统计分析。 2.院外延续干预在出院前医护人员对患者和家属进行个体化营养指导和宣教，制定个体化饮食指导单，发放健康教育手册（营养、心理、运动），指导患者使用数字化管理系统（IOT软件），发放量杯，领取体重秤，该体重秤与配套程序相匹配，该数字化系统与临床医生电脑系统相关联，医生可以实时监测患者手机端数据，患者学会在营养管理中处理基础问题。患者发放饮食与运动日记本，患者无法使用平台时使用日记本记录。 （1）营养教育 每日由小组成员在智能软件中推送营养知识，增加患者对居家营养知识的 了解，并在后台解答患者提出的问题。由营养小组成员定期组织开放式的营养教育课堂，讲解肿瘤营养相关知识，提高患者对营养的重视和认识。 （2）营养指导 根据患者个体进食和消化功能情况，营养小组实施营养咨询，营养师指导 患者或家属营养热量的计算方法、口服营养素的选择与配制。每日在后台监测患者营养改善情况，必要时给予语音通话指导。 （3）营养干预 患者居家按照营养师的方案继续每日口服或肠内补充营养素，剂量依据热量摄入和消耗平衡法，同时为患者制定运动计划，积极锻炼身体，微信步数绑定，监测患者每日运动情况，每日测量体重，通过智能IOT实时监测，干预小组每2周召开1次会议，根据IOT评估结果，对营养计划的实施效果进行评价，不断调整、优化营养管理计划。

干预措施代码：

Intervention：

Nutritional Intervention Measures within and beyond the Hospital Setting 1. In-hospital Nutritional Intervention Measures The experimental group, in addition to the control group's interventions, received enhanced standardized nutritional and psychological nursing interventions, as detailed below: (1) Team Establishment A multidisciplinary team was formed, consisting of 2 directors of gastrointestinal surgery, 8 doctors, 1 dietitian, 1 head nurse, 2 nutrition nurses (with corresponding qualifications), 7 responsibility nurses, 3 researchers, 1 follow-up specialist, and 1 psychotherapist. Basic patient information, anthropometric indices, laboratory indices, nutritional cognition, psychological status, and quality of life were recorded to establish "individual nutrition files". (2) Personnel Training Team members underwent unified training on tumor nutrition therapy, primarily conducted by doctors and dietitians. The training covered the use of various scales, personnel division of labor, and nutritional cognition among healthcare providers. Qualified personnel were required to proficiently apply their respective responsibilities to ensure homogeneity in assessment and intervention. (3) Combined Nutritional and Nursing Management Nutritional Support: Upon admission, patients received nutritional support through nutrients. Oral nutritional supplements (ONS) were the first choice for patients who could tolerate oral intake, followed by enteral nutrition via feeding tubes. Nutrition specialist nurses conducted PG-SGA assessments for patients with nutritional risk. Dietitians formulated nutrition plans based on PG-SGA scores and patients' physical conditions, developing tailored nutrition management protocols for different gastric cancer treatments. Weekly assessments of patients' weight and PG-SGA scores were conducted, with adjustments made based on identified issues and patient needs. Attending physicians issued medical orders based on patients' nutritional status and condition, while responsibility nurses implemented nutrition development plans, recorded clinical research data, and provided individualized health education to patients and their families. Psychological Nursing: According to the Chinese Guidelines for Psychological Clinical Practice in Oncology 2020, cognitive-behavioral interventions were first implemented. Healthcare providers frequently communicated with patients and their families, educating them about disease-related knowledge, such as pathogenesis, treatment methods, adverse reactions, and precautions, to enhance patients' disease cognition and knowledge-attitude-practice (KAP). Patients were encouraged to participate in relaxing and meaningful activities during treatment, enhancing their subjective and positive demand for disease management, actively participating in treatment, and improving compliance. Next, nurses promptly assessed patients' psychological status, providing targeted counseling combined with psychological education through text, videos, images, and audio-visual materials. Patients were actively inquired about their physical condition, introduced to successful cases to boost their confidence, and encouraged to receive care and support from their families, enhancing their sense of belonging. Rehabilitation Exercise: Prior to surgery, patients were encouraged to engage in aerobic exercises. Six hours post-surgery, patients were instructed to perform mild activities in bed, such as ankle flexion and extension. Twenty-four hours post-surgery, patients began ambulating, with increasing activity levels on the third postoperative day. Corridor landmarks were set up to establish daily walking goals based on patients' activity levels. Activities were scheduled 15 minutes before and 30 minutes after meals to promote gastrointestinal motility. Patients used grip strengtheners for 5 seconds per grip, with 20 grips constituting one set, practiced five sets daily, and followed the principle of gradual progression to avoid muscle strain. The entire nutritional management process was subject to quality control by department heads and head nurses. Attending physicians handled during nutritional treatment, while research nurses entered data and conducted statistical analysis. 2. Post-discharge Continuous Intervention Before discharge, healthcare providers provided individualized nutritional guidance and education to patients and their families, formulated individualized diet guidance sheets, distributed health education manuals (on nutrition, psychology, and exercise), instructed patients on using a digital management system (IOT software), issued measuring cups, and provided matched weight scales that connected to a corresponding program and the clinicians' computer systems, enabling real-time patient data monitoring. Patients were given diet and exercise journals to record information when unable to use the platform. (1) Nutritional Education Team members daily pushed nutritional knowledge through the smart software, enhancing patients' understanding of home-based nutrition and answering their questions in the backend. The nutrition team periodically organized open nutrition education classes to increase patients' awareness and importance of nutrition. (2) Nutritional Guidance Based on patients' individual eating and digestive function, the nutrition team provided nutritional counseling, with dietitians guiding patients or their families on calculating nutritional calorie intake, selecting and preparing oral nutrients. Daily monitoring of patients' nutritional improvement was conducted in the backend, with voice call guidance provided as necessary. (3) Nutritional Intervention Patients continued daily oral or enteral nutrient supplementation at home, following the dietitian's plan, with doses based on the balance between calorie intake and expenditure. Meanwhile, an exercise plan was developed, with patients' daily step count monitored through WeChat. Patients measured their weight daily, with real-time monitoring through the smart IOT system. The intervention team held meetings every two weeks to evaluate the effectiveness of the nutrition plan based on IOT assessments, continually adjusting and optimizing the nutrition management plan. Data collection was conducted at baseline, preoperative, and 1 and 3 months postoperative for patients receiving neoadjuvant therapy, and at baseline, 1 and 3 months postoperative for those without neoadjuvant therapy.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 辽宁 

市(区县)：

  

Country：

China 

Province：

Liaoning 

City：

 

单位(医院)：

辽宁省肿瘤医院 

单位级别：

三甲 

Institution
hospital：

Liaoning Cancer Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

生活质量

指标类型：

主要指标

Outcome：

Quality of life

Type：

Primary indicator

测量时间点：

基线时、术前（新辅助治疗患者）、术后1个月、术后3个月

测量方法：

欧洲癌症研究与治疗组织生活质量癌症 30 问卷调查，院期间发放纸质问卷、居家期间电话随访

Measure time point of outcome：

At baseline, before surgery(for patients receiving neoadjuvant therapy) ,1 month after surgery, and 3 months after surgery.

Measure method：

European Organization for Research and Treatment of Cancer QLQ-C30,EORTC QLQ-C30; hospitalization, paper questionnaires were distributed, and during the home stay period, follow-up was conducted via telephone.

指标中文名：

身体质量指数（BMI)

指标类型：

次要指标

Outcome：

Body Mass Index (BMI)

Type：

Secondary indicator

测量时间点：

基线时、术前（新辅助治疗患者）、术后1个月、术后3个月

测量方法：

体重秤测量后，根据BMI=体重/（身高*身高）算出

Measure time point of outcome：

At baseline, before surgery(for patients receiving neoadjuvant therapy) ,1 month after surgery, and 3 months after surgery.

Measure method：

After measuring with a weight scale, the BMI is calculated based on the formula: BMI = Weight / (Height * Height).

指标中文名：

实验室指标：PNI、淋巴细胞、甲胎蛋白、血清总蛋白、白蛋白、前白蛋白、血红蛋白

指标类型：

次要指标

Outcome：

Laboratory indicators: PNI (Prognostic Nutritional Index), lymphocytes, alpha-fetoprotein (AFP), serum total protein, albumin, prealbumin, and hemoglobin.

Type：

Secondary indicator

测量时间点：

基线时、术前（新辅助治疗患者）、术后1个月、术后3个月

测量方法：

采血测量

Measure time point of outcome：

At baseline, before surgery(for patients receiving neoadjuvant therapy) ,1 month after surgery, and 3 months after surgery.

Measure method：

Blood sampling for measurement.

指标中文名：

抑郁自评得分

指标类型：

次要指标

Outcome：

Self-rated depression score.

Type：

Secondary indicator

测量时间点：

基线时、术前（新辅助治疗患者）、术后1个月、术后3个月

测量方法：

抑郁自评量表，在院期间发放纸质问卷、居家期间电话随访

Measure time point of outcome：

At baseline, before surgery(for patients receiving neoadjuvant therapy) ,1 month after surgery, and 3 months after surgery.

Measure method：

Self-rating Depression Scale, hospitalization, paper questionnaires were distributed, and during the home stay period, follow-up was conducted via telephone.

指标中文名：

营养KAP得分

指标类型：

次要指标

Outcome：

Nutrition KAP (Knowledge, Attitude, and Practice) score.

Type：

Secondary indicator

测量时间点：

基线时、术前（新辅助治疗患者）、术后1个月、术后3个月

测量方法：

消化系统肿瘤患者营养知识-态度-行为问卷，院期间发放纸质问卷、居家期间电话随访

Measure time point of outcome：

At baseline, before surgery(for patients receiving neoadjuvant therapy) ,1 month after surgery, and 3 months after surgery.

Measure method：

Digestive Cancer Patients Nutrition Knowledge, Attitude and Practice Questionnaire; hospitalization, paper questionnaires were distributed, and during the home stay period, follow-up was conducted via telephone.

指标中文名：

人体测量学指标：小腿围、握力

指标类型：

次要指标

Outcome：

Anthropometric indicators: calf circumference, grip strength.

Type：

Secondary indicator

测量时间点：

基线时、术前（新辅助治疗患者）、术后1个月、术后3个月

测量方法：

小腿围使用卷尺测量，握力使用握力器测量

Measure time point of outcome：

At baseline, before surgery(for patients receiving neoadjuvant therapy) ,1 month after surgery, and 3 months after surgery.

Measure method：

Calf circumference is measured using a tape measure, and grip strength is measured using a grip dynamometer.

指标中文名：

营养得分（PGSGA)

指标类型：

次要指标

Outcome：

Nutrition score (Patient-Generated Subjective Global Assessment, PGSGA).

Type：

Secondary indicator

测量时间点：

基线时、术前（新辅助治疗患者）、术后1个月、术后3个月

测量方法：

患 者 参 与 的 主 观 全 面 评 定量表（PG-SGA）；在院期间发放纸质问卷、居家期间电话随访

Measure time point of outcome：

At baseline, before surgery(for patients receiving neoadjuvant therapy) ,1 month after surgery, and 3 months after surgery.

Measure method：

Patient-Generated Subjective Global Assessment,PG-SGA;hospitalization, paper questionnaires were distributed, and during the home stay period, follow-up was conducted via telephone.

指标中文名：

并发症发生率

指标类型：

次要指标

Outcome：

The incidence rate of complications

Type：

Secondary indicator

测量时间点：

术前（新辅助治疗患者）、术后1个月、术后3个月

测量方法：

医生诊断

Measure time point of outcome：

Bbefore surgery(for patients receiving neoadjuvant therapy) ,1 month after surgery, and 3 months after surgery.

Measure method：

Doctor's diagnosis

指标中文名：

肿瘤退缩分级

指标类型：

次要指标

Outcome：

Tumor Regression Grade (TRG)

Type：

Secondary indicator

测量时间点：

（新辅助治疗患者）术后1个月

测量方法：

病理检测

Measure time point of outcome：

(Neoadjuvant patients) 1 month after surgery

Measure method：

Pathological Examination

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 80 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）：

采用计算机随机分组方法，将符合入组条件患者按照2:1的比例，分为实验组和对照组

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

Using a computer-generated random grouping method, patients who meet the inclusion criteria are divided into an experimental group and a control group in a ratio of 2:1.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

盲评价者：由不知道具体分组情况的疗效评价者对受试者进行评估，所有询问内容仅限于CRF,不能同受试者交流任何与营养相关的内容。 盲统计分析者：本研究的统计分析由不知晓受试者具体分组情况的单独第三方统计人员完成。

Blinding：

Blind Evaluator: Subjects are assessed by efficacy evaluators who are unaware of the specific group assignments. All inquiries are limited to the Case Report Form (CRF), and evaluators are not allowed to communicate with subjects about any nutrition-related content. Blind Statistical Analyst: The statistical analysis of this study is conducted by an independent third-party statistician who is unaware of the specific group assignments of the subjects.

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）：

2024年3月25日，EDC共享（网址https://www.cubemedlink.com/loginController.do?login）

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

March 25th, 2024, sharing of EDC(https://www.cubemedlink.com/loginController.do?login)

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：

自己研发的EDC

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

Self-developed EDC (Electronic Data Capture)

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：

  2025-03-11 14:10:19
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