简体中文|English
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

Effects of Four Weeks of Moderate-Intensity Exercise Training and Detraining on Body Weight and Gut Microbiota in Overweight Adults

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注册号：

Registration number：

ChiCTR2600126795 

最近更新日期：

Date of Last Refreshed on：

2026-06-16 10:28:39 

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：

四周中等强度运动训练及停训后对超重成年人体重及肠道菌群的影响

Public title：

Effects of Four Weeks of Moderate-Intensity Exercise Training and Detraining on Body Weight and Gut Microbiota in Overweight Adults

注册题目简写：

English Acronym：

研究课题的正式科学名称：

四周中等强度运动训练及停训后对超重成年人体重及肠道菌群的影响

Scientific title：

Effects of Four Weeks of Moderate-Intensity Exercise Training and Detraining on Body Weight and Gut Microbiota in Overweight Adults

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：

曹又参 

研究负责人：

王棣 

Applicant：

Cao Youcan 

Study leader：

Wang Di 

申请注册联系人电话：

Applicant telephone：

+86 183 9144 4654

研究负责人电话：

Study leader's telephone：

+86 180 9260 1668

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：

yousen25@fmmu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

wangd@snnu.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：

中国陕西省西安市长安区太白南路5号

研究负责人通讯地址：

中国陕西省西安市长安区郭杜街道西长安街620号

Applicant address：

5 Taibai South Road, Chang'an District, Xi'an, Shaanxi, China

Study leader's address：

620 West Chang'an Street, Guodu Subdistrict, Chang'an District, Xi'an, Shaanxi, 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：

空军军医大学

Applicant's institution：

Air Force Medical University

研究负责人所在单位：

陕西师范大学

Affiliation of the Leader：

Shaanxi Normal University

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：

202616046

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：

陕西师范大学学术委员会

Name of the ethic committee：

Academic Committee of Shaanxi Normal University

伦理委员会批准日期：

Date of approved by ethic committee：

2026-05-12 00:00:00

伦理委员会联系人：

屈新运

Contact Name of the ethic committee：

Qu Xinyun

伦理委员会联系地址：

中国陕西省西安市长安区郭杜街道西长安街620号

Contact Address of the ethic committee：

620 West Chang'an Street, Guodu Subdistrict, Chang'an District, Xi'an, Shaanxi, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 29 8531 0338

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：

陕西师范大学

Primary sponsor：

Shaanxi Normal University

研究实施负责（组长）单位地址：

中国陕西省西安市长安区郭杜街道西长安街620号

Primary sponsor's address：

620 West Chang'an Street, Guodu Subdistrict, Chang'an District, Xi'an, Shaanxi, 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)：

陕西

市(区县)：

西安

Country：

China

Province：

Shaanxi

City：

Xi'an

单位(医院)：

陕西师范大学

具体地址：

中国陕西省西安市长安区郭杜街道西长安街620号

Institution
hospital：

Shaanxi Normal University

Address：

620 West Chang'an Street, Guodu Subdistrict, Chang'an District, Xi'an, Shaanxi, China

经费或物资来源：

陕西省高校科协青年人才托举计划项目，陕西师范大学体育学院学科建设高水平成果培育项目

Source(s) of funding：

The Youth talent program in Shaanxi science and Technology Association; the High-level achievement cultivation project for young teachers in Shaanxi Normal University

Target disease：

None

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：

单臂 

Study design：

Single arm 

研究目的：

研究四周中等强度运动训练及停训后，超重成年人体重指标的变化及肠道菌群的响应差异。运动被公认为改善代谢健康的重要手段，但其对肠道菌群的调节作用仍未完全明确。目前研究多集中于长期运动干预对菌群多样性的积极影响，而短期（如四周）中等强度训练及停训后，超重成年人的体重指标与肠道菌群如何动态响应，尚缺乏系统证据。超重状态本身与菌群失调密切相关，然而在运动介入初期，菌群对能量代谢的调节是否先于体重变化，或停训后是否出现可逆性紊乱，均是理解“运动-菌群-代谢”轴的关键缺口。填补这一空白，有助于为制定精准的、基于个体菌群特征的运动处方提供科学依据，尤其对短期干预或易中断运动的人群具有重要公共卫生意义。 本研究采用的中等强度运动干预方案已纳入世界卫生组织（WHO）及国家体育总局发布的《成年人身体活动指南》，属国际公认的科学、安全的非医疗级健康干预手段。该运动训练由具备国家体育指导员、运动处方师及美国心脏协会急救资质的专业团队进行标准化指导，相关训练场地、体成分分析设备及心率监测仪器的执行标准及第三方校准/安全检测报告等法定合规资质均完整齐备。此外，该类中等强度运动干预模式已普及多年，在多项常规减重服务及大众健康管理项目中广泛应用。 主要结局（primary outcome）：体重、腰围、体成分 次要结局（secondary outcome）：粪便菌群结构及代谢物  

Objectives of Study：

This study investigates changes in body weight indicators and gut microbiota responses in overweight adults following four weeks of moderate-intensity exercise training and subsequent detraining.Exercise is widely recognized as an important means of improving metabolic health, yet its modulatory effects on gut microbiota remain incompletely understood. Current research has largely focused on the positive effects of long-term exercise interventions on microbial diversity, whereas systematic evidence is lacking regarding the dynamic responses of body weight indicators and gut microbiota in overweight adults following short-term (e.g., four-week) moderate-intensity exercise training and subsequent detraining. Overweight status is closely associated with gut dysbiosis. However, whether gut microbiota-mediated regulation of energy metabolism precedes changes in body weight during the initial phase of exercise intervention, or whether reversible dysbiosis occurs after detraining, represents a critical gap in understanding the "exercise–gut microbiota–metabolism" axis. Addressing this gap will help provide a scientific basis for developing precise exercise prescriptions tailored to individual gut microbiota characteristics, which holds significant public health implications, particularly for populations undergoing short-term interventions or those prone to exercise discontinuation. The moderate-intensity exercise intervention protocol adopted in this study is included in the Physical Activity Guidelines for Adults published by the World Health Organization (WHO) and the General Administration of Sport of China, representing an internationally recognized, safe, non-medical health intervention. This exercise training is delivered under standardized guidance by a professional team holding qualifications as National Sports Instructors, Exercise Prescription Specialists, and American Heart Association First Aid providers. The statutory compliance documentation for the training facilities, body composition analysis equipment, and heart rate monitoring instruments—including implementation standards and third-party calibration/safety inspection reports—is complete and in order. Furthermore, this type of moderate-intensity exercise intervention model has been widely implemented for many years and is extensively used in various routine weight management services and public health management programs. Primary outcomes: Body weight, waist circumference, body composition Secondary outcomes: Fecal microbiota composition and metabolites

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. 男性或女性； 2. 年龄18-30岁； 3. BMI＞24 kg/m^2。

Inclusion criteria

1. male or female; 2. age of 18-30 years old; 3. BMI > 24 kg/m^2.

排除标准：

1. 3个月内服用过干扰研究措施的药物或补充剂（如兴奋剂）； 2. 1个月内服用过抗生素等药物； 3. 具有长期运动习惯的成年人（每周至少3次运动且持续1年以上）； 4. 患有先天性心脏疾病、冠心病、肾病、肝病、高血压。

Exclusion criteria：

1. taking drugs or supplements (e.g., stimulants) that interfere with the study measures within 3 months; 2. taking antibiotics or other drugs within one month; 3. adults with long-term exercise habits (at least 3 times per week for more than 1 year); 4. adults with congenital heart disease, coronary heart disease, kidney disease, liver disease, and hypertension.

研究实施时间：

Study execute time：

从 From 2026-06-01 00:00:00至 To 2026-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-06-30 00:00:00 至 To 2026-06-30 00:00:00  

干预措施：

Interventions：

组别：

有氧运动

样本量：

20

Group：

Aerobic exercise

Sample size：

干预措施：

每周三次，每次 35 分钟 65%–75%峰值心率的持续训练，共四周

干预措施代码：

Intervention：

Three times per week, 35 minutes of continuous training at 65%–75% of peak heart rate, for a total of four weeks.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 陕西 

市(区县)：

 西安 

Country：

China 

Province：

Shaanxi 

City：

Xi’an 

单位(医院)：

陕西师范大学 

单位级别：

大学 

Institution
hospital：

Shaanxi Normal University

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

体重

指标类型：

主要指标

Outcome：

Body weight

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

粪便菌群结构

指标类型：

次要指标

Outcome：

Fecal microbiota composition

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

粪便代谢物组

指标类型：

次要指标

Outcome：

Fecal metabolome

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

腰围

指标类型：

主要指标

Outcome：

Waist circumference

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

体成分

指标类型：

主要指标

Outcome：

Body composition

Type：

Primary 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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 30 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）：

随机分组将采用计算机程序通过区组随机法完成。

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

Random grouping will be accomplished by using a computer program through block randomization.

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：

无

Blinding：

None

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）：

在试验结束6个月内上传试验数据至临床试验公共管理平台http://www.medresman.org.cn/login.aspx。学校保存，学校审批通过后共享。

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

The clinical trial data shall be uploaded to the Clinical Trial Public Management Platform (http://www.medresman.org.cn/login.aspx) within 6 months after the completion of the trial. The data will be stored by the university and shared only after approval by the university.

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：

本研究过程中，项目负责人指派的监察员现场进行现场问卷询问，以保证参加者的权益得到保障，现场记录和报告数据准确完整无误，保证遵循已批准的研究方案和有关法规。参加研究人员必须经过统一培训，使用统一记录方式与判断标准。针对可能发生的参加者的脱落，应积极采取措施，控制脱落率在10%以内。数据管理员采用 epidata 录入程序或采用 redcap 电子问卷系统，进行数据录入与管理。为保证数据的准确性，epidata 采用双份录入并校对。所有关于本干预的资料将被保存在空军军医大学，有主要 研究者负责资料保存的完整性和安全性。未经主要研究者同意，任何数据库和资料外泄都属于违规行为。需要使用数据库的人员必须签署“数据保密协议”， 以保证数据库和资料的安全性。资料的保存要求和期限严格按照国家的有关规定执行。

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

During the course of this study, monitors assigned by the project leader conducted on-site questionnaire interviews to ensure that participants' rights and interests were protected, and that field records and reported data were accurate, complete, and in compliance with the approved research protocol and relevant regulations. Research staff participating in the study underwent unified training and used standardized recording methods and judgment criteria. In response to potential participant attrition, proactive measures were taken to control the attrition rate within 10%. The data manager used EpiData entry software or the REDCap electronic questionnaire system for data entry and management. To ensure data accuracy, EpiData employed double entry and verification. All materials related to this intervention will be stored at the Air Force Medical University, with the principal investigator responsible for maintaining the integrity and security of the data. Any unauthorized disclosure of databases or materials without the consent of the principal investigator is considered a violation. Personnel requiring access to the database must sign a "Data Confidentiality Agreement" to ensure the security of the database and materials. The requirements and duration of data storage shall be strictly in accordance with relevant national regulations.

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：

  2026-06-16 10:28:30
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