中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2500109918
最近更新日期： Date of Last Refreshed on：	2025-09-26 16:35:47
注册时间： Date of Registration：	2025-09-26 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	基于肠菌代谢探讨乒乓球运动与黄精芝麻核桃丸协同增效提高大学生体质的研究
Public title：	A study on the synergistic enhancement of physical fitness among college students through the combined effect of table tennis and Huangjing, Sesame and Walnut Pills based on the metabolism of intestinal bacteria
注册题目简写：
English Acronym：
研究课题的正式科学名称：	基于肠菌代谢探讨乒乓球运动与黄精芝麻核桃丸协同增效提高大学生体质的研究
Scientific title：	A study on the synergistic enhancement of physical fitness among college students through the combined effect of table tennis and Huangjing, Sesame and Walnut Pills based on the metabolism of intestinal bacteria
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：	吕游	研究负责人：	徐蒙
Applicant：	You Lv	Study leader：	Xu Meng
申请注册联系人电话： Applicant telephone：	+86 158 4114 7623	研究负责人电话： Study leader's telephone：	+86 188 1375 7109
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：	lvyou1212023@163.com	研究负责人电子邮件： Study leader's E-mail：	wszyy0324@yeah.net
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：	云南省昆明市雨花路1076号云南中医药大学	研究负责人通讯地址：	云南省昆明市雨花路1076号云南中医药大学
Applicant address：	No. 1076, Yuhua Road, Kunming City, Yunnan Province, China - Yunnan University of Traditional Chinese Medicine	Study leader's address：	No. 1076, Yuhua Road, Kunming City, Yunnan Province, China - Yunnan University of Traditional Chinese Medicine
申请注册联系人邮政编码： Applicant postcode：	650500	研究负责人邮政编码： Study leader's postcode：	650500
申请人所在单位：	云南中医药大学
Applicant's institution：	Yunnan University of Traditional Chinese Medicine
研究负责人所在单位：	云南中医药大学
Affiliation of the Leader：	Yunnan University of Traditional Chinese 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：	云中二附院伦审[2023-020]	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：	云南中医药大学第二附属医院医学伦理委员会
Name of the ethic committee：	The Medical Ethics Committee of the Second Affiliated Hospital of Yunnan University of Traditional Chinese Medicine
伦理委员会批准日期： Date of approved by ethic committee：	2023-12-20 00:00:00
伦理委员会联系人：	陈柏君
Contact Name of the ethic committee：	Chen Baijun
伦理委员会联系地址：	云南省昆明市雨花路1076号云南中医药大学
Contact Address of the ethic committee：	No. 1076, Yuhua Road, Kunming City, Yunnan Province, China - Yunnan University of Traditional Chinese Medicine
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 138 8824 4951	伦理委员会联系人邮箱： Contact email of the ethic committee：	lvyou1212023@163.com

研究实施负责（组长）单位：

云南中医药大学第二附属医院

Primary sponsor：

Yunnan University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

云南省昆明市官渡区东郊路161号

Primary sponsor's address：

No. 1076, Yuhua Road, Kunming City, Yunnan Province, China - Yunnan University of Traditional Chinese Medicine

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	云南	市(区县)：
Country：	China	Province：	Yunnan	City：
单位(医院)：	云南省中西医结合慢病防治重点实验室	具体地址：	云南省昆明市呈贡区雨花路1076号云南中医药大学
Institution hospital：	Yunnan Provincial Key Laboratory for Integrated Traditional Chinese and Western Medicine in Chronic Disease Prevention and Treatment	Address：	No. 1076, Yuhua Road, Chengguan District, Kunming City, Yunnan Province; Yunnan University of Traditional Chinese Medicine

经费或物资来源：

2024年云南省中医药基础研究联合专项面上项目申报课题

Source(s) of funding：

2024 Annual Project Application for the Joint Specialized Research Program on Traditional Chinese Medicine Foundation Studies in Yunnan Province

研究疾病：

大学生体质下降

Target disease：

The physical fitness of college students is declining

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：

近年来大学生体质下降问题日益突出，亟待关注。肠道微生态研究表明，规律运动可调节肠菌代谢增强体质，肠道微环境重塑可提升运动表现和意愿，而本项目组研发药食同源食品黄精芝麻核桃丸可通过调节肠菌代谢提升机体运动后抗疲劳能力。然二者是否可协同增效调节肠菌代谢提高大学生体质有待探究。据此提出“乒乓球运动与黄精芝麻核桃丸可调节肠菌代谢，且两者在提高大学生体质、促进身心健康上具有协同增效作用”的科学假说。拟采用体质健康测试和组学分析技术，通过检测大学生志愿者肺活量、坐位体前屈、立定跳远、引体向上（男）、仰卧起坐（女）、 50 米跑、 1000 米跑（男）/ 800 米跑（女），以及肠道菌群及其代谢产物短链脂肪酸，观察并探讨乒乓球运动与黄精芝麻核桃丸协同对体质改善的作用及机理，以期为提升大学生体质提供新思路、新方法。

Objectives of Study：

In recent years, the issue of declining physical fitness among college students has become increasingly prominent and requires urgent attention. Research on intestinal microecology indicates that regular exercise can regulate intestinal flora metabolism to enhance physical fitness, and the remodeling of the intestinal microenvironment can improve exercise performance and willingness. The research team has developed a food and medicine alike product, Huangjing Sesame Walnut Pills, which can regulate intestinal flora metabolism to enhance the body's anti-fatigue ability after exercise. However, it remains to be explored whether these two can synergistically enhance the regulation of intestinal flora metabolism and improve the physical fitness of college students. Based on this, a scientific hypothesis is proposed: "Table tennis exercise and Huangjing Sesame Walnut Pills can regulate intestinal flora metabolism, and both have a synergistic effect in improving the physical fitness of college students and promoting physical and mental health." We plan to use physical fitness tests and omics analysis techniques to detect the lung capacity, sit-to-stand flexibility, standing long jump, pull-ups (for men), sit-ups (for women), 50-meter run, 1000-meter run (for men)/800-meter run (for women), as well as intestinal flora and its metabolites (short-chain fatty acids), to observe and explore the synergistic effect of table tennis exercise and Huangjing Sesame Walnut Pills on physical fitness improvement and its mechanism, in order to provide new ideas and methods for improving the physical fitness of college students.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

Enroll qualified college student volunteers
Undergraduate and postgraduate students from Yunnan University of Traditional Chinese Medicine in Kunming, whose household registration is from various prefectures, cities, districts and counties of Yunnan Province, a total of 108 people were recruited. They signed the informed consent form and met the following volunteer screening criteria.
Volunteer inclusion criteria
1. BMI value between 18 and 30, where BMI = weight (kg) / height² (m);
2. Age between 18 and 28 years old (including 18 and 28 years old), gender not restricted;
3. No limb defects, no mental illness, no severe organic lesions, no cardiovascular or cerebrovascular diseases;
4. No history of long-term medication;
5. Volunteers are aware of the purpose of this study, the effects of exercise and food, and possible reactions, are willing to participate in this experimental study, and will consume specific foods as required until the end of the study, and sign the informed consent form.

排除标准：

1.半年内有运动严重受伤史，一个月内体重有大幅变化者； 2.试验中使用的特定食品及食品中某些成分（如黄精、核桃、芝麻、玫瑰等）过敏史者； 3.长期服用肠道抗菌药物者，3 个月内参加过或正在参加其他药物临床试验的患者； 4.未按要求进行试验的志愿者。

Exclusion criteria：

1. Those who have had a serious injury due to exercise within the past six months, or who have experienced significant weight changes within the past month; 2. Those with a history of allergic reactions to specific foods and certain components in foods (such as rehmannia, walnuts, sesame, roses, etc.) used in the test; 3. Those who have been taking intestinal antibacterial drugs for a long time, or who have participated in or are currently participating in other drug clinical trials within the past three months; 4. Volunteers who did not follow the test requirements.

研究实施时间：

Study execute time：

从 From 2023-12-21 00:00:00至 To 2024-05-17 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-01-26 00:00:00 至 To 2024-03-20 00:00:00

干预措施：

Interventions：

组别：	空白对照组	样本量：	36
Group：	Blank control group	Sample size：	36
干预措施：	无干预措施	干预措施代码：
Intervention：	No intervention measures	Intervention code：

组别：	乒乓球训练组	样本量：	36
Group：	Table tennis training group	Sample size：	36
干预措施：	5次/周，60分/次	干预措施代码：
Intervention：	5 times per week, 60 minutes each time	Intervention code：

组别：	乒乓球训练组+黄精芝麻核桃丸组	样本量：	36
Group：	Table tennis training group + Huangjing sesame walnut pill group	Sample size：	36
干预措施：	运动干预5次/周，60分/次;食品干预7克/粒，4粒/次，1次/日，5次/周，均持续8周	干预措施代码：
Intervention：	Exercise intervention: 5 times per week, 60 minutes each time; Food intervention: 7 grams per piece, 4 pieces each time, 1 time per day, 5 times per week, all for 8 weeks	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	云南	市(区县)：
Country：	China	Province：	Yunnan	City：
单位(医院)：	云南中医药大学呈贡校区	单位级别：	大学
Institution hospital：	Chenggong Campus of Yunnan University of Traditional Chinese Medicine	Level of the institution：	University

测量指标：

Outcomes：

指标中文名：	肠道菌群	指标类型：	主要指标
Outcome：	Gut microbiota	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	短链脂肪酸	指标类型：	主要指标
Outcome：	Short-chain fatty acids	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	国家学生体质健康测试	指标类型：	次要指标
Outcome：	National Student Physical Fitness Test	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	人体体成分分析	指标类型：	次要指标
Outcome：	Human body composition analysis	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：	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：

结束

/Completed

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	28	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）：

为了确保分组的随机性和公平性，本研究采用随机数表法进行分组。项目组成员周圣宇首先为108位学生编写了从001到108的数字编号。随后，使用随机数表法将这些编号随机分配给每位学生，确保每位学生获得的编号是随机且独立的。具体分组如下：空白组：编号为001到036的学生被分为空白组。乒乓球训练组：编号为037到072的学生被分为乒乓球训练组。乒乓球训练+黄精芝麻核桃丸干预组：编号为073到0108的学生被分为乒乓球训练+黄精芝麻核桃丸干预组。通过随机数表法，我们确保了每个学生被分配到不同组别的概率是相同的，从而提高了研究设计的科学性和结果的可靠性。

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

To ensure the randomness and fairness of the grouping, this study adopted the random number table method for grouping. Zhou Shengyu, a member of the project team, first assigned 90 students with numbers ranging from 001 to 108. Subsequently, using the random number table method, these numbers were randomly assigned to each student, ensuring that each student received a random and independent number. The specific grouping is as follows: Blank group: Students with numbers ranging from 001 to 036 were assigned to the blank group. Table tennis training group: Students with numbers ranging from 037 to 072 were divided into the table tennis training group. Table tennis training + Huangjing sesame walnut pill intervention group: Students with numbers ranging from 073 to 108 were assigned to the table tennis training + Huangjing sesame walnut pill intervention group. Through the random number table method, we ensured that the probability of each student being assigned to a different group was the same, thereby improving the scientificity of the research design and the reliability of the results.

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：	无
Blinding：	None
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

是否共享原始数据： IPD sharing	是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）：	2025年8月 NCBI
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	August 2025, NCBI
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：	1.首先对于原始数据进行现场记录于记录本上，而后在利用Excel表记录于电脑中 2.设计CRF 3.按照现场记录规范填写数据 4.建库设置权限 5.形成数据流 6.严格质控 7.将上传的数据导出备份
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	1. Firstly, record the original data on a notebook and then record it in an Excel table on the computer. 2. Design a CRF. 3. Fill in the data according to the on-site recording standards. 4. Set up the database and define permissions. 5. Formulate the data flow. 6. Implement strict quality control. 7. Export and back up the uploaded data.
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：	2025-09-26 16:35:30