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审核状态: Project audit state: |
通过审核 Successful |
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注册号: Registration number: |
ChiCTR2400092063 |
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最近更新日期: Date of Last Refreshed on: |
2024-11-08 10:37:32 |
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注册时间: Date of Registration: |
2024-11-08 00:00:00 |
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注册号状态: |
预注册 |
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Registration Status: |
Prospective registration |
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注册题目: |
液体蛋白补充对大学生抗阻训练期间肌肉酸痛及运动表现的影响 |
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Public title: |
Effects of liquid protein supplementation on muscle soreness and exercise performance of college students during resistance training |
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注册题目简写: |
蛋白补充实验 |
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English Acronym: |
Protein supplement test |
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研究课题的正式科学名称: |
液体蛋白补充对大学生抗阻训练期间肌肉酸痛及运动表现的影响 |
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Scientific title: |
Effects of liquid protein supplementation on muscle soreness and exercise performance of college students during resistance training |
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研究课题代号(代码): Study subject ID: |
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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: |
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申请注册联系人: |
刘欣源 |
研究负责人: |
刘欣源 |
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Applicant: |
Liu Xinyuan |
Study leader: |
Liu Xinyuan |
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申请注册联系人电话: Applicant telephone: |
+86 182 9396 5350 |
研究负责人电话: Study leader's telephone: |
+86 182 9396 5350 |
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申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
liuxinyuan326@163.com |
研究负责人电子邮件: Study leader's E-mail: |
liuxinyuan326@163.com |
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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): |
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申请注册联系人通讯地址: |
北京市海淀区上地街道信息路48号北京体育大学 |
研究负责人通讯地址: |
北京市海淀区上地街道信息路48号北京体育大学 |
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Applicant address: |
Beijing Sport University, No. 48 Information Road, Shangdi Street, Haidian District, Beijing |
Study leader's address: |
Beijing Sport University, No. 48 Information Road, Shangdi Street, Haidian District, Beijing |
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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: |
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申请人所在单位: |
北京体育大学 |
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Applicant's institution: |
Beijing Sport University |
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研究负责人所在单位: |
北京体育大学 |
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Affiliation of the Leader: |
Beijing Sport University |
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是否获伦理委员会批准: |
是/Yes |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
2024296H |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
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批准本研究的伦理委员会名称: |
北京体育大学运动科学实验伦理委员会 |
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Name of the ethic committee: |
Ethics Committee of sports Science Experiment, Beijing Sport University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2024-09-09 00:00:00 |
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伦理委员会联系人: |
梅涛 |
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Contact Name of the ethic committee: |
Mei Tao |
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伦理委员会联系地址: |
北京市海淀区信息路48号 |
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Contact Address of the ethic committee: |
48 Xinyi Road, Haidian District, Beijing |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 10 6298 9306 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
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研究实施负责(组长)单位: |
北京体育大学运动人体科学学院 |
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Primary sponsor: |
College of Sports and Human Science, Beijing Sport University |
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研究实施负责(组长)单位地址: |
北京市海淀区信息路48号 |
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Primary sponsor's address: |
48 Xinyi Road, Haidian District, Beijing |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
北京品酷运动营养技术有限公司 |
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Source(s) of funding: |
Beijing Pinku Sports Nutrition Technology Co., LTD |
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Target disease: |
obesity |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
I期临床试验 | ||||||||||||||||||||||
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Study phase: |
1 |
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研究设计: |
随机交叉对照 |
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Study design: |
Cross-over |
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研究目的: |
规律的训练是维持骨骼肌质量和力量的重要因素。在规律训练过程中,保证良好的营养补充,不仅仅能够积极应对蛋白质的分解代谢和合成代谢平衡,还能够预防损伤,并获得运动后促进恢复的作用。蛋白质补充品在运动健身领域中的应用已成为一种普遍的趋势。然而,对于液体乳清蛋白在大学生抗阻训练期间的确切效果和剂量尚未有充分的科学研究支撑。此外,乳清蛋白补充能否对大学生抗阻训练期间缓解肌肉酸痛产生积极作用也尚无定论。因此,本研究:研究一旨在对男性健身爱好者一次大强度抗阻训练后进行液体乳清蛋白的营养补充,观察液体乳清蛋白补充对一次性大强度抗阻训练后出现的肌肉酸痛是否会有改善效果,并通过探究补充后氨基酸的吸收速率,以明确营养补充产生效果的时机。在此基础上,研究二对参与8周抗阻训练的大学生进行液体乳清蛋白的营养补充,然后对其身体形态、肌肉力量、耐力和恢复能力以及内分泌指标进行评估,以及对整体运动表现进行观察和记录,以评估补充液体乳清蛋白是否对身体形态、生理功能及运动表现产生差异。 |
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Objectives of Study: |
Regular training is an important factor in maintaining skeletal muscle mass and strength. In the regular training process, to ensure good nutritional supplements, not only can actively respond to the balance of protein catabolic and anabolic, but also to prevent damage, and to promote recovery after exercise. The application of protein supplements in the field of sports and fitness has become a general trend. However, the exact effects and dosage of liquid whey protein during resistance training in college students have not been fully supported by scientific research. In addition, whether whey protein supplementation can have a positive effect on relieving muscle soreness during resistance training in college students is also inconclusive. Therefore, in this study: Study I aims to provide nutritional supplement of liquid whey protein to male fitness enthusiasts after a high-intensity resistance training, observe whether liquid whey protein supplement can improve muscle soreness after a one-time high-intensity resistance training, and explore the absorption rate of amino acids after supplementation to determine the timing of the effect of nutritional supplement. On this basis, in study 2, nutritional supplementation of liquid whey protein was carried out on college students who participated in 8-week resistance training, and then their body shape, muscle strength, endurance and recovery ability and endocrine indexes were evaluated, as well as the overall exercise performance was observed and recorded to evaluate whether supplementation of liquid whey protein had any difference on body shape, physiological function and exercise performance. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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纳入标准: |
研究一: 1.年龄在 18-24 岁男性; 2.在本研究前有一年以上健身经验,且最近三个月有规律抗阻训练习惯 (大于等于3次/周); 3.在本研究前三个月没有服用蛋白粉、蛋白饮料、或维生素等营养补充剂以及激素类药物。 排除女性的原因是研究一为一次性大强度抗阻训练,考虑到实验的安全性,仅选用男性受试者。 研究二: 1.年龄在 18-24 岁; 2.在本研究前半年无规律运动训练习惯 (小于等于2次/周); 3.在本研究开始前三个月没有服用蛋白粉、蛋白饮料或维生素等营养补充剂以及激素类药物。 |
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Inclusion criteria |
Study 1: 1.Male aged 18-24 years; 2.Have more than one year of fitness experience before this study, and have regular resistance training habits in the last three months (more than or equal to 3 times/week); 3.No protein powder, protein drink, vitamin or other nutritional supplements or hormone drugs were taken during the three months prior to the study. The reason for excluding women is that study I is a one-time high-intensity resistance training, considering the safety of the experiment, only male subjects are selected. Study 2: 1. Aged 18-24 years old; 2.In the first half year of this study, irregular exercise training habits (less than or equal to 2 times/week); 3.No nutritional supplements such as protein powders, protein drinks, vitamins or hormone medications were taken during the three months prior to the study. |
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排除标准: |
有明确运动禁忌症或其他影响运动计划的疾病,坚持素食或对乳清蛋白过敏。 |
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Exclusion criteria: |
Have clear contraindications to exercise or other diseases that affect your exercise program, adhere to a vegetarian diet or are allergic to whey protein. |
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研究实施时间: Study execute time: |
从 From 2024-09-07 00:00:00至 To 2025-02-28 00:00:00 |
征募观察对象时间: Recruiting time: |
从From 2024-11-10 00:00:00 至 To 2025-02-28 00:00:00 |
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干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
随机数字表 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
Table of random numbers |
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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 |
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盲法: |
蛋白饮和安慰剂采用相同包装和口味,同时将蛋白饮和安慰剂分别标记上A和B,然后按照随机分配表上确定的治疗组和对照组的顺序号将不同饮品进行分类。 盲法为双盲,对实验操作人员和所有受试者进行盲法。 |
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Blinding: |
Protein drinks and placebo were packaged in the same packaging and taste, and the protein drinks and placebo were labeled A and B, respectively, and then classified according to the sequence number of treatment and control groups as determined on the random assignment table. The blind method was double blind, and the experimental operator and all subjects were blinded. |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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是否共享原始数据: IPD sharing |
Yes |
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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3月1日公开,通过文件共享,通过百度网盘共享文件,https://yun.baidu.com/disk/main?_at_=1726838862743#/index?category=all |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
Released March 1, 2025,,https://yun.baidu.com/disk/main?_at_=1726838862743#/index?category=all |
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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: |
采用问卷调查法和实验采集数据;制定数据管理策略 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
The data were collected by questionnaire survey and experiment. Develop a data management strategy |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |