ChiCTR2600126822 版本V1.0 版本创建时间2026/06/16 17:20:51 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：

 ChiCTR2600126822 

最近更新日期：

Date of Last Refreshed on：

 2026-06-16 17:20:41 

注册时间：

Date of Registration：

 2026-06-16 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

探究超加工饮食和低加工饮食对肠道微生物及宿主代谢稳态的影响

Public title：

The effects of ultra-processed and minimally processed diets on gut microbiota and host metabolic homeostasis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

探究超加工饮食和低加工饮食对肠道微生物及宿主代谢稳态的影响

Scientific title：

The effects of ultra-processed and minimally processed diets on gut microbiota and host metabolic homeostasis

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：

刘瑞欣 

研究负责人：

宁光 

Applicant：

Ruixin Liu 

Study leader：

Guang Ning 

申请注册联系人电话：

Applicant telephone：

 +86 21 64370045

研究负责人电话：

Study leader's
telephone：

+86 23 64370045

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：

 xiner198287@163.com

研究负责人电子邮件：

Study leader's E-mail：

 ng10679@rjh.com.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：

上海市黄浦区瑞金二路 197 号

研究负责人通讯地址：

上海市瑞金二路197号

Applicant address：

No. 197, Ruijin Er Road, Huangpu District, Shanghai, China

Study leader's address：

Ruijin Hospital, 197 Rui Jin 2nd Road, Shanghai, 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：

上海交通大学医学院附属瑞金医院

Applicant's institution：

Ruijin Hospital, Shanghai jiaotong University School of Medicine

研究负责人所在单位：

上海交通大学医学院附属瑞金医院

Affiliation of the Leader：

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

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：

 （2026）临伦审第（317）号

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：

上海交通大学医学院附属瑞金医院涉及人体的临床与科研项目伦理委员会

Name of the ethic committee：

The Ethics Committee for Clinical and Research Projects Involving Human Subjects of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-04-23 00:00:00

伦理委员会联系人：

赵彦琳

Contact Name of the ethic committee：

Yanlin Zhao

伦理委员会联系地址：

上海市瑞金二路197号

Contact Address of the ethic committee：

Ruijin Hospital, 197 Rui Jin 2nd Road, Shanghai, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 21 80585870

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 zyl02d86@rjh.com.cn

研究实施负责（组长）单位：

上海交通大学医学院附属瑞金医院

Primary sponsor：

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

研究实施负责（组长）单位地址：

上海市瑞金二路197号

Primary sponsor's address：

Ruijin Hospital, 197 Rui Jin 2nd Road, Shanghai, 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)：

上海市

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海交通大学医学院附属瑞金医院

具体地址：

上海市瑞金二路197号

Institution
hospital：

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Address：

Ruijin Hospital, 197 Rui Jin 2nd Road, Shanghai, China

经费或物资来源：

四大慢病（重大专项）

Source(s) of funding：

National Major Science and Technology Special Projects - Four Major Chronic Diseases

研究疾病：

无  

Target disease：

None

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

研究设计：

随机交叉对照 

Study design：

Cross-over 

研究目的：

主要目的： 1. 探究超加工饮食与低加工饮食两种膳食模式对受试者肠道菌群的影响； 2. 探究两种膳食模式对受试者代谢组、蛋白组等其他组学指标的影响； 次要目的： 1. 探究两种膳食模式对受试者的体重体成分等人体测量学指标的影响； 2. 探究两种膳食模式对受试者糖脂相关代谢指标的影响； 3. 探究两种膳食模式对受试者能量代谢指标的变化特征  

Objectives of Study：

Main objectives: 1. To investigate the effects of ultra-processed diet and low-processed diet on the gut microbiota of the subjects; 2. To explore the effects of the two dietary patterns on other omics indicators such as the metabolic and proteomic profiles of the subjects; Secondary objectives: 1. To examine the effects of the two dietary patterns on the body measurement indicators such as body weight and body composition of the subjects; 2. To investigate the effects of the two dietary patterns on the metabolic indicators related to sugar and lipids of the subjects; 3. To explore the changes in energy metabolism indicators in the subjects due to the two dietary patterns.

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18-45岁； 2.身体质量指数（BMI）范围为 18 kg/m^2 <=BMI < 30 kg/m^2； 3.在筛选期前3个月里体重稳定（过去3个月体重变化<=5%）； 4.详细了解试验性质、意义、可能的获益，可能带来的不便和潜在的危险；能够遵守研究规定的饮食计划，无严重食物过敏或饮食禁忌；理解研究程序自愿参加本研究并签署知情同意书，并按时完成访视和样本采集。

Inclusion criteria

1. Age: 18 - 45 years old; 2. Body Mass Index (BMI) range: 18 kg/m^2 <= BMI < 30 kg/m^2; 3. Weight remained stable in the three months prior to the screening period (weight change in the past three months <= 5%); 4. Thoroughly understand the nature, significance, potential benefits, possible inconveniences and potential risks of the trial; able to follow the dietary plan stipulated in the study, without severe food allergies or dietary restrictions; understand the research procedures, voluntarily participate in this study and sign the informed consent form, and complete the visits and sample collection on time.

排除标准：

1.患有1型糖尿病T1DM、2型糖尿病T2DM、单基因突变糖尿病、由胰腺损伤所致的糖尿病或其他继发性糖尿病（如库欣综合征、甲状腺功能异常或肢端肥大症等引起的糖尿病）者； 2.有其他严重器质性心脏病，如先天性心脏病、风湿性心脏病、肥厚性或扩充性心肌病、慢性充血性心力衰竭（NYHA>=III级）等者，或接受介入式疗法或使用了心脏支架者，或有难治性高血压或三级高血压者； 3.甲状腺功能亢进或减退者； 4.在过去5年内有已进行治疗或未进行治疗的器官系统肿瘤（局部皮肤基底细胞癌除外），无论其是否有局部复发或转移的证据； 5.有食物过敏史； 5.有食物过敏史； 6.有影响食物消化吸收的胃肠道疾病（如严重腹泻、便秘、肠易激综合征、炎症性肠病、活动性消化道溃疡、急性胆囊炎等）者；严重腹泻指每天水样便3次或以上，并持续3天或以上，严重便秘指每周排便2次或以下，伴有排便困难； 7.有任何精神疾病或病史者；癫痫患者或者在抗癫痫治疗中，使用抗抑郁药物者； 8.有任何传染性疾病病史者，如乙肝、丙肝、肺结核、梅毒、艾滋病等； 9.患有严重感染、重度贫血、中性粒细胞减低症者； 10.筛选期前1年内接受过重大手术（阑尾炎、疝气手术除外）； 11.既往有肠段切除史，或筛选前1年之内接受过其他消化道手术（如胆囊切除术）史，或半年内接受过其他非消化道手术史； 12.曾经或现正使用口服降糖药或胰岛素或肠促胰素类药物控制糖尿病； 13.筛选期前3个月内或计划在试验期间使用控制体重药物（包括减肥药）、皮质类固醇等激素类药物（包括口服、肌肉注射或静脉全身给药、非消化道给药或关节内给药）者； 14.筛选期前1个月内经常性使用抗生素类药物，每次使用持续3天或以上； 15.筛选期前1个月内服用了益生菌或益生元产品； 16.严重肝肾功能障碍，或筛选时丙氨酸氨基转移酶（ALT）或天门冬氨酸氨基转移酶（AST）>=2.5×ULN、血清肌酐＞ULN、肾小球滤过率（eGFR）＜60mL/min/1.73m^2（采用MDRD公式计算）； 17.在研究期间计划用药物（包括中药、中成药）等方法干预、改变体重者； 18.有活性物质滥用史者和/或酗酒者（男性摄入酒精＞40克/天，女性摄入酒精＞20克/天，40g酒精约为1000mL啤酒（6度），或500mL红酒或黄酒（12度），或100mL白酒（50度））； 19.妊娠、哺乳期女性者； 20.有严重的乳糖不耐受者； 21.目前正在参加或近3个月内参加过其他临床研究者（特别是参加过任何药物、医疗器械或其他干预性临床试验者）； 22.研究者认为的任何不宜参加本研究的情况。

Exclusion criteria：

1. Those with type 1 diabetes (T1DM), type 2 diabetes (T2DM), monogenic mutation diabetes, diabetes caused by pancreatic damage, or other secondary diabetes (such as diabetes caused by Cushing's syndrome, thyroid dysfunction, or acromegaly, etc.); 2. Those with other severe organic heart diseases, such as congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy, chronic congestive heart failure (NYHA >= III grade), etc., or those who have received interventional therapy or used heart stents, or have refractory hypertension or grade III hypertension; 3. Those with hyperthyroidism or hypothyroidism; 4. Those who have had organ system tumors (except for local basal cell carcinoma of the skin) within the past 5 years, regardless of whether there is evidence of local recurrence or metastasis; 5. Those with a history of food allergy; 6. Those with gastrointestinal diseases that affect food digestion and absorption (such as severe diarrhea, constipation, irritable bowel syndrome, inflammatory bowel disease, active gastrointestinal ulcers, acute cholecystitis, etc.); severe diarrhea refers to three or more watery stools per day for 3 days or more, and severe constipation refers to less than 2 stools per week, accompanied by difficulty in defecation; 7. Those with any mental illness or history of mental illness; patients with epilepsy or those using antidepressants during antiepileptic treatment; 8. Those with any infectious disease history, such as hepatitis B, hepatitis C, tuberculosis, syphilis, AIDS, etc.; 9. Those with severe infection, severe anemia, neutropenia; 10. Those who have undergone major surgery within 1 year before the screening period (except for appendicitis and hernia surgery); 11. Those who have had intestinal resection history, or those who have had other digestive tract surgeries within 1 year before the screening (such as cholecystectomy), or those who have had other non-digestive tract surgeries within 6 months before the screening; 12. Those who have used oral hypoglycemic drugs, insulin, or incretin drugs to control diabetes; 13. Those who plan to use weight control drugs (including weight loss drugs), corticosteroids and other hormone drugs (including oral, intramuscular injection or intravenous systemic administration, non-digestive tract administration or intra-articular administration) during the screening period; 14. Those who frequently use antibiotics drugs within 1 month before the screening period, each use lasting for 3 days or more; 15. Those who have taken probiotics or prebiotics products within 1 month before the screening period; 16. Those with severe liver or kidney dysfunction, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 2.5×ULN, serum creatinine > ULN, glomerular filtration rate (eGFR) < 60 mL/min/1.73m^2 (calculated using the MDRD formula) within the screening period; 17. Those who plan to use drugs (including traditional Chinese medicine, Chinese patent medicine) to intervene or change body weight during the study period; 18. Those with a history of substance abuse and/or alcoholism (men consuming more than 40 grams of alcohol per day, women consuming more than 20 grams of alcohol per day, 40 grams of alcohol is approximately 1000 mL of beer (6 degrees), or 500 mL of red wine or yellow wine (12 degrees), or 100 mL of white wine (50 degrees)); 19. Pregnant or lactating women; 20. Those with severe lactose intolerance; 21. Those who are currently participating in or have participated in other clinical studies within the past 3 months (especially those who have participated in any drug, medical device or interventional clinical trials); 22. Any situation deemed inappropriate for participation in this study by the investigator.

研究实施时间：

Study execute time：

从 From 2026-04-30 00:00:00至 To 2029-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-16 00:00:00 至 To 2026-07-09 00:00:00

干预措施：

Interventions：

组别：

饮食干预组1

样本量：

 20

Group：

Dietary Intervention Group 1

Sample size：

干预措施：

前两周为低加工饮食，后两周为超加工饮食，无洗脱期

干预措施代码：

Intervention：

The first two weeks were a low-processed diet, and the following two weeks were an ultra-processed diet. There was no washout period.

Intervention code：

组别：

饮食干预组2

样本量：

 20

Group：

Dietary Intervention Group 2

Sample size：

干预措施：

前两周为超加工饮食，后两周为低加工饮食，无洗脱期

干预措施代码：

Intervention：

The first two weeks were of ultra-processed diet, and the next two weeks were of low-processed diet. There was no washout period.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 上海市 

市(区县)：

  

Country：

China

Province：

Shanghai

City：

单位(医院)：

 上海交通大学医学院附属瑞金医院 

单位级别：

 三级甲等 

Institution
hospital：

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

体脂、骨骼肌含量等体成分指标

指标类型：

次要指标

Outcome：

Body composition indicators such as body fat and skeletal muscle mass.

Type：

Secondary indicator

测量时间点：

筛选期、第2周干预结束时、第4周干预结束时

测量方法：

由检测中心的机器（Inbody）及工作人员辅助下测量。

Measure time point of outcome：

Screening period、At the end of the 2-week intervention、At the end of the 4-week intervention

Measure method：

Measured with the assistance of the testing center's machine (Inbody) and staff.

指标中文名：

血常规、尿常规、血生化等

指标类型：

次要指标

Outcome：

Blood routine, urine routine, blood biochemistry

Type：

Secondary indicator

测量时间点：

筛选期、第2周干预结束时、第4周干预结束时

测量方法：

血、尿常规及血生化采集样本送至检验科检测。

Measure time point of outcome：

Screening period、At the end of the 2-week intervention、At the end of the 4-week intervention

Measure method：

Blood and urine routine tests, as well as blood biochemistry, are performed by collecting samples and sending them to the Department of Laboratory Medicine for testing.

指标中文名：

外周血的代谢组学、蛋白组学、转录组学等

指标类型：

主要指标

Outcome：

Peripheral blood metabolomics, proteomics, and transcriptomics.

Type：

Primary indicator

测量时间点：

筛选期、第2周干预结束时、第4周干预结束时

测量方法：

采集血液样本测序及组学分析

Measure time point of outcome：

Screening period、At the end of the 2-week intervention、At the end of the 4-week intervention

Measure method：

Collection of blood samples for sequencing and multi-omics analysis.

指标中文名：

血脂检查：甘油三酯（TG）、总胆固醇（TC）、低密度脂蛋白胆固醇（LDL-C）、高密度脂蛋白胆固醇（HDL-C）等

指标类型：

次要指标

Outcome：

Blood lipid examination: TG、TC、LDL-C、HDL-C

Type：

Secondary indicator

测量时间点：

筛选期、第2周干预结束时、第4周干预结束时

测量方法：

采集血液送至检验科检测。

Measure time point of outcome：

Screening period、At the end of the 2-week intervention、At the end of the 4-week intervention

Measure method：

Collection of blood samples and delivery to the Department of Laboratory Medicine for testing.

指标中文名：

人体能量代谢舱

指标类型：

次要指标

Outcome：

Human energy metabolic chamber

Type：

Secondary indicator

测量时间点：

筛选期、第2周干预结束时、第4周干预结束时

测量方法：

受试者进入代谢舱后开始评估能量代谢情况。

Measure time point of outcome：

Screening period、At the end of the 2-week intervention、At the end of the 4-week intervention

Measure method：

Upon entering the metabolic chamber, participants began the assessment of energy metabolism.

指标中文名：

糖代谢相关指标：空腹血浆葡萄糖（FPG），餐后2h血浆葡萄糖、空腹胰岛素（FINS）、餐后2h胰岛素、空腹胰高血糖素样肽-1（GLP-1）、餐后2h GLP-1、胰岛素敏感性、动态血糖监测（CGM）；

指标类型：

次要指标

Outcome：

Glucose metabolism related indicators：FPG; 2hPG; FINS; 2hINS; fasting GLP-1; 2h GLP-1; Insulin Sensitivity; CGM

Type：

Secondary indicator

测量时间点：

筛选期、第2周干预结束时、第4周干预结束时

测量方法：

采集血液送至检验科检测

Measure time point of outcome：

Screening period、At the end of the 2-week intervention、At the end of the 4-week intervention

Measure method：

Collection of blood samples and delivery to the Department of Laboratory Medicine for testing.

指标中文名：

基本生命体征（血压、呼吸、脉搏、体温）；身高、体重、BMI、三围（颈围、腰围、臀围）；

指标类型：

次要指标

Outcome：

Basic vital signs (blood pressure, respiratory rate, pulse, and body temperature) ; height, weight, BMI, and body circumferences (neck, waist, and hip circumference) ;

Type：

Secondary indicator

测量时间点：

筛选期、第2周干预结束时、第4周干预结束时

测量方法：

由检测中心的机器及工作人员辅助下测量。

Measure time point of outcome：

Screening period、At the end of the 2-week intervention、At the end of the 4-week intervention

Measure method：

Measurements are conducted by laboratory equipment and assisted by the staff at the testing center.

指标中文名：

肠道菌群宏基因组测序、转录组学、代谢组学、蛋白组学等

指标类型：

主要指标

Outcome：

Metagenomic sequencing, transcriptomics, metabolomics, and proteomics of the gut microbiota.

Type：

Primary indicator

测量时间点：

筛选期、第2周干预结束时、第4周干预结束时

测量方法：

采集粪便样本测序及组学分析

Measure time point of outcome：

Screening period、At the end of the 2-week intervention、At the end of the 4-week intervention

Measure method：

Collection of fecal samples for metagenomic sequencing and multi-omics analysis.

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：

粪便

组织：

Sample Name：

Feces

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation 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 18 岁 years
最大 Max age 45 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）：

本研究由不参与受试者招募和临床干预的独立研究人员，使用专业统计软件生成分层区组随机序列。随机化按性别和BMI进行分层，区组长度固定为4。产生的分配序列通过“顺序编号的不透光密封信封（SNOSE）”进行隐藏，并在临床筛选阶段由研究者按受试者入组顺序依次开启。

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

The randomization sequence of this study is generated using professional statistical software by independent researchers who are not involved in participant recruitment or clinical intervention. A stratified block randomization method is employed, with stratification based on gender and baseline BMI. The block size is fixed at 4. Allocation concealment is achieved through sequentially numbered, opaque, sealed envelopes (SNOSE), which are opened by the investigators in the strict order of participant enrollment during the clinical screening phase.

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：

开放标签

Blinding：

Open-label study

是否共享原始数据：

IPD sharing

否No

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）：

无

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

None

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：

本研究采用纸质病例报告表（CRF）结合电子数据库（如Epidata）的方式进行数据管理。研究者及授权的研究人员应按照GCP要求和方案规定，及时、准确、完整地将受试者数据记录于CRF中，数据录入完成后，由独立的临床监查员（CRA）对数据与原始病历进行核查，确保数据与原始记录一致。所有数据的修改均须留有痕迹。研究结束后，所有数据将备份保存，由瑞金医院按照GCP要求存档。数据的访问权限由主要研究者授权，并根据不同角色（如研究者、CRA、统计师等）设置分级管理权限，确保数据安全与保密。

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

This study uses paper Case Report Forms (CRF) combined with electronic databases (e.g., Epidata) for data management. Researchers and authorized study personnel shall record subject data in the CRF in a timely, accurate, and complete manner in accordance with GCP requirements and the study protocol. After data entry is completed, an independent Clinical Research Associate (CRA) will verify the data against the original medical records to ensure consistency between the data and the source documents. All modifications to the data must be traceable. Upon study completion, all data will be backed up and preserved, and archived by Ruijin Hospital in accordance with GCP requirements. Data access rights are authorized by the principal investigator, with hierarchical management privileges assigned based on different roles (e.g., investigators, CRA, statisticians, etc.) to ensure data security and confidentiality.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-06-16 17:20:41