ChiCTR2400092063 版本V1.0 版本创建时间2024/11/08 10:37:40 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:

ChiCTR2400092063 

最近更新日期:

Date of Last Refreshed on:

2024-11-08 10:37:32 

注册时间:

Date of Registration:

2024-11-08 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

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

Public title:

Effects of liquid protein supplementation on muscle soreness and exercise performance of college students during resistance training

注册题目简写:

蛋白补充实验

English Acronym:

Protein supplement test

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

Scientific title:

Effects of liquid protein supplementation on muscle soreness and exercise performance of college students during resistance training

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:

刘欣源 

研究负责人:

刘欣源 

Applicant:

Liu Xinyuan 

Study leader:

Liu Xinyuan 

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

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:

liuxinyuan326@163.com

研究负责人电子邮件:

Study leader's E-mail:

liuxinyuan326@163.com

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:

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

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

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:

北京体育大学

Applicant's institution:

Beijing Sport University

研究负责人所在单位:

北京体育大学

Affiliation of the Leader:

Beijing Sport 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:

2024296H

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:

北京体育大学运动科学实验伦理委员会

Name of the ethic committee:

Ethics Committee of sports Science Experiment, Beijing Sport University

伦理委员会批准日期:

Date of approved by ethic committee:

2024-09-09 00:00:00

伦理委员会联系人:

梅涛

Contact Name of the ethic committee:

Mei Tao

伦理委员会联系地址:

北京市海淀区信息路48号

Contact Address of the ethic committee:

48 Xinyi Road, Haidian District, Beijing

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:

研究实施负责(组长)单位:

北京体育大学运动人体科学学院

Primary sponsor:

College of Sports and Human Science, Beijing Sport University

研究实施负责(组长)单位地址:

北京市海淀区信息路48号

Primary sponsor's address:

48 Xinyi Road, Haidian District, Beijing

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京体育大学

具体地址:

北京市海淀区上地街道信息路48号北京体育大学

Institution
hospital:

Beijing Sport University

Address:

Beijing Sport University, No. 48 Information Road, Shangdi Street, Haidian District, Beijing

经费或物资来源:

北京品酷运动营养技术有限公司

Source(s) of funding:

Beijing Pinku Sports Nutrition Technology Co., LTD

Target disease:

obesity

Target disease code:

研究类型:

干预性研究

Study type:

Interventional study

研究所处阶段:

I期临床试验 

Study phase:

1

研究设计:

随机交叉对照 

Study design:

Cross-over 

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。  

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.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

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。

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.

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。

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.

研究实施时间:

Study execute time:

From 2024-09-07 00:00:00 To 2025-02-28 00:00:00  

征募观察对象时间:

Recruiting time:

From 2024-11-10 00:00:00 To 2025-02-28 00:00:00  

干预措施:

Interventions:

组别:

蛋白补充组(研究一)

样本量:

5

Group:

Protein Supplement Group (Study 1)

Sample size:

干预措施:

研究一招募北京体育大学男性健身爱好者10人,年龄18-24岁,在干预开始前实施健康检查以排除干扰因素,采用问卷形式对受试者年龄、性别、病史、健康状况、体力活动水平以及日常膳食进行调查,并签订知情同意书。 采用随机交叉双盲实验,将受试者随机分为乳清蛋白组(W组,n=5)与对照组(C组,n=5),一次干预后W组和C组交换补剂再次进行干预,期间进行7天的洗脱。 急性抗阻运动的动作方式为采用杠铃完成深蹲和卧推运动。受试者要求下蹲时股骨大转子和膝关节为同一水平位置,然后再完全伸膝,卧推时要求受试者下落时杠铃接触上胸部,举起时肘关节完全伸直。运动训练负荷遵循美国力量和体能协会制定的指南,在干预前先进行1RM测试,以便确定后续受试者的干预强度。训练具体方案如下: ①准备活动:采用 50% 1RM 深蹲和卧推各重复 8-10 次,然后休息60 s。 ②抗阻运动顺序为先完成深蹲后完成卧推。前 4 组深蹲负荷为 70 % 1RM,每组重复 8 次,组间休息 60s;第 4 组完成后休息 90s,随后再完成负荷为 50% 1RM 深蹲 4 组,第 1、2 组每组重复 8 次,3、4 组重复至不能完成为止(若第3组已力竭则不用做第4组),组间休息 60 s,第 4 组完成休息 150 s。随后更换动作,完成负荷为 70 % 1RM 卧推 4 组,每组重复 8 次,组间休息 60 s;第 4 组完成后休息 90 s,随后以 50 % 1RM 完成卧推 4 组,第 1、2 组重复 8 次,第 3、4 组重复至不能完成为止(若第3组已力竭则不用做第4组)。 此外,营养补充方案如下:W组在抗阻训练前1小时、抗阻训练后即刻各补充1瓶品酷极速蛋白产品(300ml); C组在抗阻训练前1小时、抗阻训练后即刻各补充安慰剂300ml。 在正式实验开始前,对受试者进行饮食教育(推荐膳食结构为10-20% 蛋白质、50-65% 碳水化合物和20-30% 脂肪)。受试者在干预前完成3天(2工作日1休息日)饮食记录。

干预措施代码:

Intervention:

Study 1 recruited 10 male fitness enthusiasts from Beijing Sport University, aged 18-24 years old. Before the intervention, health examination was carried out to eliminate disturbing factors. The age, sex, medical history, health status, physical activity level and daily diet of the subjects were investigated by questionnaire, and informed consent was signed. The subjects were randomly divided into whey protein group (group W, n=5) and control group (group C, n=5) in a randomized cross-over double-blind experiment. After one intervention, group W and group C exchanged supplements for another intervention, during which they were eluted for 7 days. The action mode of acute resistance exercise is squat and bench press with barbell. Subjects were asked to squat at the same level as the femoral trochanter and knee joint, then fully extend the knee, bench press subjects were asked to drop the bar to touch the upper chest, and lift the elbow joint fully straight. The exercise training load follows the guidelines established by the American Strength and Conditioning Association, and a 1RM test is performed prior to the intervention in order to determine the intensity of the intervention in subsequent subjects. The specific training plan is as follows: ① Preparation activity: Repeat the 50% 1RM squat and bench press 8-10 times each, then rest for 60 s. ② The order of resistance exercise is to complete the squat first and then the bench press. The first 4 groups of squat load was 70% 1RM, each group repeated 8 times, rest between groups 60s; After the completion of the fourth group, rest 90s, and then complete the four sets of squat with a load of 50% 1RM. The first and second groups are repeated 8 times each, and the third and fourth groups are repeated until they cannot be completed (if the third group is exhausted, there is no need to do the fourth group). The rest between the groups is 60 s, and the fourth group is finished with a rest of 150 s. Then the movement was changed, and the load was 70% 1RM bench press 4 groups, each group repeated 8 times, and the rest between the groups was 60 s; After the completion of group 4, rest for 90 s, and then complete the bench press 4 sets at 50% 1RM, and repeat 8 times in groups 1 and 2, and repeat in groups 3 and 4 until they cannot be completed (if group 3 is exhausted, do not do group 4). In addition, the nutritional supplement program was as follows: Group W supplemented 1 bottle of Pinku protein product (300ml) 1 hour before and immediately after resistance training; Group C was given placebo 300ml one hour before and immediately after resistance training. Prior to the start of the experiment, participants were given dietary education (recommended dietary structure is 10-20% protein, 50-65% carbohydrate, and 20-30% fat). Participants completed diet records for 3 days (2 working days and 1 rest day) before intervention.

Intervention code:

组别:

安慰剂组(研究一)

样本量:

5

Group:

Placebo Group (Study 1)

Sample size:

干预措施:

研究一招募北京体育大学男性健身爱好者10人,年龄18-24岁,在干预开始前实施健康检查以排除干扰因素,采用问卷形式对受试者年龄、性别、病史、健康状况、体力活动水平以及日常膳食进行调查,并签订知情同意书。 采用随机交叉双盲实验,将受试者随机分为乳清蛋白组(W组,n=5)与对照组(C组,n=5),一次干预后W组和C组交换补剂再次进行干预,期间进行7天的洗脱。 急性抗阻运动的动作方式为采用杠铃完成深蹲和卧推运动。受试者要求下蹲时股骨大转子和膝关节为同一水平位置,然后再完全伸膝,卧推时要求受试者下落时杠铃接触上胸部,举起时肘关节完全伸直。运动训练负荷遵循美国力量和体能协会制定的指南,在干预前先进行1RM测试,以便确定后续受试者的干预强度。训练具体方案如下: ①准备活动:采用 50% 1RM 深蹲和卧推各重复 8-10 次,然后休息60 s。 ②抗阻运动顺序为先完成深蹲后完成卧推。前 4 组深蹲负荷为 70 % 1RM,每组重复 8 次,组间休息 60s;第 4 组完成后休息 90s,随后再完成负荷为 50% 1RM 深蹲 4 组,第 1、2 组每组重复 8 次,3、4 组重复至不能完成为止(若第3组已力竭则不用做第4组),组间休息 60 s,第 4 组完成休息 150 s。随后更换动作,完成负荷为 70 % 1RM 卧推 4 组,每组重复 8 次,组间休息 60 s;第 4 组完成后休息 90 s,随后以 50 % 1RM 完成卧推 4 组,第 1、2 组重复 8 次,第 3、4 组重复至不能完成为止(若第3组已力竭则不用做第4组)。 此外,营养补充方案如下:W组在抗阻训练前1小时、抗阻训练后即刻各补充1瓶品酷极速蛋白产品(300ml); C组在抗阻训练前1小时、抗阻训练后即刻各补充安慰剂300ml。 在正式实验开始前,对受试者进行饮食教育(推荐膳食结构为10-20% 蛋白质、50-65% 碳水化合物和20-30% 脂肪)。受试者在干预前完成3天(2工作日1休息日)饮食记录。

干预措施代码:

Intervention:

Study 1 recruited 10 male fitness enthusiasts from Beijing Sport University, aged 18-24 years old. Before the intervention, health examination was carried out to eliminate disturbing factors. The age, sex, medical history, health status, physical activity level and daily diet of the subjects were investigated by questionnaire, and informed consent was signed. The subjects were randomly divided into whey protein group (group W, n=5) and control group (group C, n=5) in a randomized cross-over double-blind experiment. After one intervention, group W and group C exchanged supplements for another intervention, during which they were eluted for 7 days. The action mode of acute resistance exercise is squat and bench press with barbell. Subjects were asked to squat at the same level as the femoral trochanter and knee joint, then fully extend the knee, bench press subjects were asked to drop the bar to touch the upper chest, and lift the elbow joint fully straight. The exercise training load follows the guidelines established by the American Strength and Conditioning Association, and a 1RM test is performed prior to the intervention in order to determine the intensity of the intervention in subsequent subjects. The specific training plan is as follows: ① Preparation activity: Repeat the 50% 1RM squat and bench press 8-10 times each, then rest for 60 s. ② The order of resistance exercise is to complete the squat first and then the bench press. The first 4 groups of squat load was 70% 1RM, each group repeated 8 times, rest between groups 60s; After the completion of the fourth group, rest 90s, and then complete the four sets of squat with a load of 50% 1RM. The first and second groups are repeated 8 times each, and the third and fourth groups are repeated until they cannot be completed (if the third group is exhausted, there is no need to do the fourth group). The rest between the groups is 60 s, and the fourth group is finished with a rest of 150 s. Then the movement was changed, and the load was 70% 1RM bench press 4 groups, each group repeated 8 times, and the rest between the groups was 60 s; After the completion of group 4, rest for 90 s, and then complete the bench press 4 sets at 50% 1RM, and repeat 8 times in groups 1 and 2, and repeat in groups 3 and 4 until they cannot be completed (if group 3 is exhausted, do not do group 4). In addition, the nutritional supplement program was as follows: Group W supplemented 1 bottle of Pinku protein product (300ml) 1 hour before and immediately after resistance training; Group C was given placebo 300ml one hour before and immediately after resistance training. Prior to the start of the experiment, participants were given dietary education (recommended dietary structure is 10-20% protein, 50-65% carbohydrate, and 20-30% fat). Participants completed diet records for 3 days (2 working days and 1 rest day) before intervention.

Intervention code:

组别:

蛋白补充组(研究二)

样本量:

14

Group:

Protein supplement Group (Study 2)

Sample size:

干预措施:

研究二招募北京体育大学在校大学生28人(男生14人,女生14人),在干预开始前实施健康检查以排除干扰因素,采用问卷形式对受试者年龄、性别、病史、健康状况、体力活动水平以及日常膳食进行调查,并签订知情同意书。 在干预前一周收集受试者基本信息,以及身体形态、身体成分、生理机能。 采用随机对照实验,将受试者随机分为液体乳清蛋白组(W组,n=14)与空白对照组(C组,n=14),所有受试者均进行为期8周,每周4的抗阻训练。 于干预后第4、8周测试身体形态、身体成分指标、生理机能的变化。 在第一次训练前、训练后即刻、和训练后2小时采集肘静脉血;并在第8周最后一次训练前、训练后即刻和训练后2小时采集肘静脉血。 受试者执行8周的抗阻训练干预,每周进行4次,周一和周五进行臀腿部训练,周三和周六进行胸肩部训练,周二和周日休息。臀腿部训练包括深蹲、硬拉、坐姿器械腿屈伸和坐姿器械腿弯举四个练习动作,胸肩部训练包括平板卧推、平板哑铃飞鸟、坐姿哑铃推举和哑铃弯举四个练习动作。受试者在专业教练员的指导下进行动作练习,确保动作标准化。运动训练负荷遵循美国力量和体能协会制定的指南,在干预前先进行1RM测试,确定后续受试者的干预强度。第1-2周,受试者每个动作进行5组,每组10-12 RM,组间间歇2-3 min。第3-4周,相同动作进行5组,每组8-10 RM,组间间歇1-2 min。第5-8周,相同动作进行5组,每组6-8RM,组间间歇1-2 min。每两周更新1RM的测试。 此外,营养补充方案如下:W组训练日运动后即刻补充300ml品酷极速蛋白产品,C组训练日运动后即刻补充300ml安慰剂。 在正式营养补充开始前,对受试者进行饮食教育(推荐膳食结构为10-20% 蛋白质、50-65% 碳水化合物和20-30% 脂肪)。受试者在干预前、干预开始后的每周分别完成3天(2工作日1休息日)饮食记录。

干预措施代码:

Intervention:

In the second study, 28 college students (14 male and 14 female) were recruited from Beijing Sport University. Before the intervention, health examination was carried out to eliminate interfering factors. The age, gender, medical history, health status, physical activity level and daily diet of the subjects were investigated by questionnaire, and informed consent was signed. Basic information, as well as body shape, body composition, and physiological function, was collected one week before the intervention. In a randomized controlled experiment, subjects were randomly divided into liquid whey protein group (group W, n=14) and blank control group (group C, n=14). All subjects underwent resistance training 4 times a week for 8 weeks. The changes of body shape, body composition index and physiological function were measured at 4 and 8 weeks after intervention. Elbow venous blood was collected before the first training, immediately after training, and 2 hours after training. Elbow venous blood was collected before, immediately after and 2 hours after the last training in week 8. Participants performed an eight-week resistance training intervention four times a week, with hip and leg training on Mondays and Fridays, chest and shoulder training on Wednesdays and Saturdays, and rest on Tuesdays and Sundays. Hip leg training includes squat, hard pull, sitting machine leg flexion and sitting machine leg bend four exercises, chest and shoulder training includes flat bench press, flat dumbbell bird, sitting dumbbell press and dumbbell bend four exercises. The subjects conduct movement exercises under the guidance of professional coaches to ensure the standardization of movements. Exercise training load follows the guidelines established by the American Strength and Conditioning Association, and a 1RM test is performed before the intervention to determine the intensity of the intervention in subsequent subjects. In week 1-2, subjects performed 5 sets of 10-12 RM for each movement, with an interval of 2-3 min between the groups. At week 3-4, the same action was performed in 5 groups, 8-10 RM per group, with an interval of 1-2 min between the groups. In the 5th to 8th week, the same action was performed in 5 groups, 6-8RM for each group, with an interval of 1-2 min between the groups. Update 1RM test every two weeks. In addition, the nutritional supplement plan was as follows: Group W immediately added 300ml of Pinku protein products after exercise on training day, and group C immediately added 300ml of placebo after exercise on training day. Prior to the start of formal nutritional supplementation, subjects were given dietary education (recommended dietary structure is 10-20% protein, 50-65% carbohydrate, and 20-30% fat). Participants completed diet records for 3 days (2 working days and 1 rest day) each week before and after the intervention.

Intervention code:

组别:

安慰剂组(研究二)

样本量:

14

Group:

Placebo Group (Study 2)

Sample size:

干预措施:

研究二招募北京体育大学在校大学生28人(男生14人,女生14人),在干预开始前实施健康检查以排除干扰因素,采用问卷形式对受试者年龄、性别、病史、健康状况、体力活动水平以及日常膳食进行调查,并签订知情同意书。 在干预前一周收集受试者基本信息,以及身体形态、身体成分、生理机能。 采用随机对照实验,将受试者随机分为液体乳清蛋白组(W组,n=14)与空白对照组(C组,n=14),所有受试者均进行为期8周,每周4的抗阻训练。 于干预后第4、8周测试身体形态、身体成分指标、生理机能的变化。 在第一次训练前、训练后即刻、和训练后2小时采集肘静脉血;并在第8周最后一次训练前、训练后即刻和训练后2小时采集肘静脉血。 受试者执行8周的抗阻训练干预,每周进行4次,周一和周五进行臀腿部训练,周三和周六进行胸肩部训练,周二和周日休息。臀腿部训练包括深蹲、硬拉、坐姿器械腿屈伸和坐姿器械腿弯举四个练习动作,胸肩部训练包括平板卧推、平板哑铃飞鸟、坐姿哑铃推举和哑铃弯举四个练习动作。受试者在专业教练员的指导下进行动作练习,确保动作标准化。运动训练负荷遵循美国力量和体能协会制定的指南,在干预前先进行1RM测试,确定后续受试者的干预强度。第1-2周,受试者每个动作进行5组,每组10-12 RM,组间间歇2-3 min。第3-4周,相同动作进行5组,每组8-10 RM,组间间歇1-2 min。第5-8周,相同动作进行5组,每组6-8RM,组间间歇1-2 min。每两周更新1RM的测试。 此外,营养补充方案如下:W组训练日运动后即刻补充300ml品酷极速蛋白产品,C组训练日运动后即刻补充300ml安慰剂。 在正式营养补充开始前,对受试者进行饮食教育(推荐膳食结构为10-20% 蛋白质、50-65% 碳水化合物和20-30% 脂肪)。受试者在干预前、干预开始后的每周分别完成3天(2工作日1休息日)饮食记录。

干预措施代码:

Intervention:

In the second study, 28 college students (14 male and 14 female) were recruited from Beijing Sport University. Before the intervention, health examination was carried out to eliminate interfering factors. The age, gender, medical history, health status, physical activity level and daily diet of the subjects were investigated by questionnaire, and informed consent was signed. Basic information, as well as body shape, body composition, and physiological function, was collected one week before the intervention. In a randomized controlled experiment, subjects were randomly divided into liquid whey protein group (group W, n=14) and blank control group (group C, n=14). All subjects underwent resistance training 4 times a week for 8 weeks. The changes of body shape, body composition index and physiological function were measured at 4 and 8 weeks after intervention. Elbow venous blood was collected before the first training, immediately after training, and 2 hours after training. Elbow venous blood was collected before, immediately after and 2 hours after the last training in week 8. Participants performed an eight-week resistance training intervention four times a week, with hip and leg training on Mondays and Fridays, chest and shoulder training on Wednesdays and Saturdays, and rest on Tuesdays and Sundays. Hip leg training includes squat, hard pull, sitting machine leg flexion and sitting machine leg bend four exercises, chest and shoulder training includes flat bench press, flat dumbbell bird, sitting dumbbell press and dumbbell bend four exercises. The subjects conduct movement exercises under the guidance of professional coaches to ensure the standardization of movements. Exercise training load follows the guidelines established by the American Strength and Conditioning Association, and a 1RM test is performed before the intervention to determine the intensity of the intervention in subsequent subjects. In week 1-2, subjects performed 5 sets of 10-12 RM for each movement, with an interval of 2-3 min between the groups. At week 3-4, the same action was performed in 5 groups, 8-10 RM per group, with an interval of 1-2 min between the groups. In the 5th to 8th week, the same action was performed in 5 groups, 6-8RM for each group, with an interval of 1-2 min between the groups. Update 1RM test every two weeks. In addition, the nutritional supplement plan was as follows: Group W immediately added 300ml of Pinku protein products after exercise on training day, and group C immediately added 300ml of placebo after exercise on training day. Prior to the start of formal nutritional supplementation, subjects were given dietary education (recommended dietary structure is 10-20% protein, 50-65% carbohydrate, and 20-30% fat). Participants completed diet records for 3 days (2 working days and 1 rest day) each week before and after the intervention.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京体育大学 

单位级别:

大学 

Institution
hospital:

Beijing Sport University

Level of the institution:

University

测量指标:

Outcomes:

指标中文名:

氨基酸总量

指标类型:

主要指标

Outcome:

Total amino acid

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清睾酮

指标类型:

主要指标

Outcome:

testosterone

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清皮质醇

指标类型:

主要指标

Outcome:

serum cortisol

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

表面肌电

指标类型:

主要指标

Outcome:

surface myoelectricity

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

等速肌力

指标类型:

主要指标

Outcome:

isokinetic muscle strength

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌肉围度

指标类型:

次要指标

Outcome:

Muscle circumference

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

身体成分

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:

指标中文名:

白细胞介素-6

指标类型:

主要指标

Outcome:

IL-6

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白细胞介素-10

指标类型:

主要指标

Outcome:

IL-10

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:

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:

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 years
最大 Max age 26 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):

随机数字表

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

Table of random numbers

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:

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。

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.

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

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

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

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

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

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:

 2024-11-08 10:37:32