ChiCTR2600124614 版本V1.0 版本创建时间2026/05/14 14:39:09 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：

 ChiCTR2600124614 

最近更新日期：

Date of Last Refreshed on：

 2026-05-14 14:38:28 

注册时间：

Date of Registration：

 2026-05-14 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

硒营养强化鸡蛋对中老年人免疫功能的作用

Public title：

Effects of selenium enriched eggs on immune function in middle-aged and elderly people

注册题目简写：

English Acronym：

研究课题的正式科学名称：

硒营养强化鸡蛋对中老年人免疫功能的作用

Scientific title：

Effects of selenium enriched eggs on immune function in middle-aged and elderly people

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：

唐胜 

研究负责人：

唐玉涵 

Applicant：

Sheng Tang 

Study leader：

Yuhan Tang 

申请注册联系人电话：

Applicant telephone：

 +86 187 7166 9434

研究负责人电话：

Study leader's
telephone：

+86 150 7126 9339

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：

 t2353749207@163.com

研究负责人电子邮件：

Study leader's E-mail：

 2015220157@hust.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：

湖北省武汉市硚口区航空路13号

研究负责人通讯地址：

湖北省武汉市硚口区航空路13号

Applicant address：

No. 13, Hangkong Road, Qiaokou District, Wuhan City, Hubei Province

Study leader's address：

No. 13, Hangkong Road, Qiaokou District, Wuhan City, Hubei 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：

华中科技大学同济医学院

Applicant's institution：

Hubei University of Science and Technology - Tongji Medical College

研究负责人所在单位：

华中科技大学同济医学院

Affiliation of the Leader：

Hubei University of Science and Technology - Tongji Medical College

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：

 [2025]论审字(S175)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：

华中科技大学同济医学院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Tongji Medical College, Huazhong University of Science and Technology

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-12-31 00:00:00

伦理委员会联系人：

伦理委员会

Contact Name of the ethic committee：

Ethics Committee

伦理委员会联系地址：

湖北省武汉市硚口区航空路13号

Contact Address of the ethic committee：

No. 13, Hangkong Road, Qiaokou District, Wuhan City, Hubei Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 27 8369 1785

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 tongjilunli@vip.163.com

研究实施负责（组长）单位：

华中科技大学同济医学院

Primary sponsor：

Hubei University of Science and Technology - Tongji Medical College

研究实施负责（组长）单位地址：

湖北省武汉市硚口区航空路13号

Primary sponsor's address：

No. 13, Hangkong Road, Qiaokou District, Wuhan City, Hubei Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖北

市(区县)：

武汉

Country：

China

Province：

Hubei

City：

Wuhan

单位(医院)：

华中科技大学同济医学院

具体地址：

湖北省武汉市硚口区航空路13号

Institution
hospital：

Hubei University of Science and Technology - Tongji Medical College

Address：

No. 13, Hangkong Road, Qiaokou District, Wuhan City, Hubei Province

经费或物资来源：

国家重点研发计划子课题/2024YFF1106204

Source(s) of funding：

Key Research Project Sub-topic of the National Key R&D Program / 2024YFF1106204

研究疾病：

无  

Target disease：

NA

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：

随机平行对照 

Study design：

Parallel 

研究目的：

我们预期通过膳食补充硒营养强化鸡蛋，可以有效提高老年人血清硒水平，增强其抗氧化能力，改善免疫细胞功能，调节炎症反应，最终改善老年人的整体免疫功能，并潜在地延缓免疫衰老进程。因此，本研究拟通过三臂随机双盲安慰剂对照干预设计，选取湖北省武汉市某社区50-70岁的成年人作为研究对象，随机分为空白对照组、干预组与阳性对照组，纳入后空白组每周摄入鸡蛋不超过2个，干预组和对照组分别给予富硒鸡蛋和安慰剂干预4个月。比较三组间干预前后免疫功能的改善情况，观察机体免疫表型和功能、氧化应激和炎症反应变化，评估富硒鸡蛋对老年人免疫功能的干预作用，探讨其可能的作用机制。值得注意的是，在该研究中，我们同时记录受试者生活方式，进而分层分析其差异对富硒鸡蛋调节免疫的影响。本研究旨在提供短期高水平因果证据，为其应用提供人群科学理论依据。  

Objectives of Study：

We expect that by supplementing selenium nutrition in eggs and consuming them as part of the diet, we can effectively increase the serum selenium levels in the blood of the elderly, enhance their antioxidant capacity, improve the function of immune cells, regulate inflammatory responses, and ultimately improve the overall immune function of the elderly, and potentially delay the process of immune aging. Therefore, this study intends to adopt a three-arm randomized double-blind placebo-controlled intervention design. We will select adults aged 50-70 years from a certain community in Wuhan City, Hubei Province, as the research subjects. They will be randomly divided into a blank control group, an intervention group, and a positive control group. After inclusion, the blank group will consume no more than 2 eggs per week, while the intervention group and the control group will be given selenium-enriched eggs and placebo interventions respectively for 4 months. The improvement of immune function before and after the intervention in the three groups will be compared, and the changes in immune phenotype and function, oxidative stress and inflammatory responses of the body will be observed. The intervention effect of selenium-enriched eggs on the immune function of the elderly will be evaluated, and its possible mechanism will be explored. It is worth noting that in this study, we also record the lifestyle of the subjects, and then conduct stratified analysis of the differences in the impact of selenium-enriched eggs on immunity. This study aims to provide short-term high-level causal evidence and provide population-based scientific theoretical basis for its application.

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. 长期居住在研究所在社区或指定区域，方便随访和鸡蛋派送； 2. 既往12个月内曾发生至少一次上呼吸道感染；； 3. 同意在试验期间遵守饮食规定（每日吃一枚水煮蛋，或限制吃蛋），且无已知鸡蛋过敏史，配合采血； 4. 年龄在50 -70岁之间； 5. 签署知情同意书。

Inclusion criteria

1. Live in the research institute's community or designated area for a long time, which is convenient for follow-up and egg delivery; 2. Have had at least one upper respiratory tract infection within the past 12 months; 3. Agree to follow the dietary regulations during the trial (eat one boiled egg per day, or limit egg consumption), have no known egg allergy history, and cooperate with blood sampling; 4. Age between 50 and 70 years old; 5. Sign the informed consent form.

排除标准：

1.鸡蛋/硒过敏史； 2.严重肝肾功能不全； 3.患有免疫系统疾病或处于治疗期间； 4.近期感染或接种疫苗； 5.患有影响营养吸收的疾病（胃肠道、胰腺、肝胆疾病等）； 6.长期/正在服用影响硒代谢的药物（利尿剂、金属螯合剂等）； 7.正在服用其他硒摄入来源（硒补充剂、富硒食品等）； 8.有沟通及认知障碍者。 9.参加本试验的同时参加其他试验； 10.不能通过电话或网络进行每日随访，或近半年有旅行/出差计划； 11.患有高血脂症、不能长期食用鸡蛋者； 12.根据研究者的临床判断，受试者有或目前存在急性或进行性、不稳定或无法控制的临床疾病 13.有免疫介导或临床相关关节炎/关节痛病史； 14.出现过抽血的禁忌症； 15.长期服用抗炎或抗氧化补充剂。 16.长期酗酒吸烟者。

Exclusion criteria：

1. History of egg or selenium allergy; 2. Severe liver and kidney dysfunction; 3. Having an immune system disorder or undergoing treatment; 4. Recent infection or vaccination; 5. Having a disease that affects nutrient absorption (gastrointestinal, pancreatic, liver and gallbladder diseases, etc.); 6. Long-term or current use of drugs that affect selenium metabolism (diuretics, metal chelators, etc.); 7. Currently taking other sources of selenium intake (selenium supplements, selenium-rich foods, etc.); 8. Individuals with communication and cognitive impairments. 9. Participating in this trial while also participating in other trials; 10. Unable to undergo daily follow-up via phone or internet, or having travel/duty plans in the past six months; 11. Having hyperlipidemia and unable to consume eggs for a long time; 12. According to the investigator's clinical judgment, the subject has or currently has acute or progressive, unstable or uncontrollable clinical diseases; 13. Having a history of immune-mediated or clinically relevant arthritis/joint pain; 14. Having contraindications for blood sampling; 15. Long-term use of anti-inflammatory or antioxidant supplements; 16. Long-term heavy drinkers and smokers.

研究实施时间：

Study execute time：

从 From 2026-05-20 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-05-20 00:00:00 至 To 2026-06-01 00:00:00

干预措施：

Interventions：

组别：

空白对照组

样本量：

 65

Group：

Blank control group

Sample size：

干预措施：

不干预

干预措施代码：

Intervention：

No intervention.

Intervention code：

组别：

阳性对照组

样本量：

 65

Group：

Positive control group

Sample size：

干预措施：

每天食用一枚普通鸡蛋

干预措施代码：

Intervention：

Consume one regular egg every day

Intervention code：

组别：

干预组

样本量：

 65

Group：

Intervention group

Sample size：

干预措施：

每天食用一枚富硒鸡蛋

干预措施代码：

Intervention：

Consume one selenium-rich egg every day

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖北 

市(区县)：

 武汉 

Country：

China

Province：

Hubei

City：

Wuhan

单位(医院)：

 华中科技大学同济医学院 

单位级别：

 大学 

Institution
hospital：

Hubei University of Science and Technology - Tongji Medical College

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

感染事件发生次数和时间

指标类型：

主要指标

Outcome：

The frequency and timing of infection incidents

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血浆和尿液中硒浓度和血液中GPx3活性

指标类型：

次要指标

Outcome：

Selenium concentrations in plasma and urine and the activity of GPx3 in blood

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

免疫细胞比例及血清免疫球蛋白水平

指标类型：

次要指标

Outcome：

The proportion of immune cells and the levels of serum immunoglobulins

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：

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：

标本中文名：

粪便

组织：

Sample Name：

Feces

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 50 岁 years
最大 Max age 70 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）：

随机序列由本研究的生物统计学家采用协变量约束随机化方法产生。首先根据关键基线协变量（如年龄、性别、感染严重程度等）设定可接受的平衡约束条件；随后通过计算机程序模拟大量潜在的随机分配序列，并计算每个序列的协变量不平衡度；剔除不满足预设平衡约束的序列后，从剩余的 “合格序列” 中随机抽取一个作为最终的随机分配序列。整个过程在统计分析计划中预先设定，并由独立统计师完成，以保证随机性和平衡性。

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

The random sequence was generated by the biostatistician of this study using the covariate-constrained randomization method. Firstly, acceptable balance constraints were set based on key baseline covariates (such as age, gender, severity of infection, etc.); then, a large number of potential random allocation sequences were simulated through a computer program, and the covariate imbalance degree of each sequence was calculated; sequences that did not meet the preset balance constraints were eliminated, and one random sequence from the remaining "qualified sequences" was selected as the final random allocation sequence. The entire process was pre-defined in the statistical analysis plan and completed by an independent statistician to ensure randomness and balance.

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：

本研究采用双盲设计，研究对象、现场干预实施人员及结局评价人员均不知晓分组分配及干预物类型。所有干预物外观、包装、气味、规格完全一致，仅以无差异数字编号标识。编号与分组对应关系由第三方独立保管，研究全程严格保密，直至数据统计分析结束后统一揭盲。

Blinding：

This study adopted a double-blind design. The research subjects, the on-site intervention implementers, and the outcome evaluators were all unaware of the group allocation and the type of intervention materials. All the intervention materials had exactly the same appearance, packaging, smell, and specifications, and were only identified by identical numerical codes. The correspondence between the codes and the groups was independently kept by a third party. The study was strictly confidential throughout, and the blind was lifted uniformly after the data statistical analysis was completed.

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

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：

数据采集将使用结构化病例记录表（CRF），由经过培训的研究人员填写。所有数据将通过基于互联网的电子数据采集系统（EDC，如 ResMan）进行录入与管理，系统将进行逻辑核查和数据追踪。数据管理员将负责数据质疑与清理，最终数据库锁定后用于统计分析。

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

Data collection will be conducted using structured case record forms (CRFs), which will be filled out by trained researchers. All data will be entered and managed through an internet-based electronic data collection system (EDC, such as ResMan), and the system will perform logical checks and data tracking. The data manager will be responsible for data verification and cleaning, and the final database will be locked for statistical 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：

  2026-05-14 14:38:28