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To investigate a multi-ingredient supplement, containing turmeric and apple extracts, chicken essence, and multimineral, on muscle damage after a rugby match

注册号：

Registration number：

ITMCTR2023000036

最近更新日期：

Date of Last Refreshed on：

2023-08-28

注册时间：

Date of Registration：

2023-08-28

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

Public title：

To investigate a multi-ingredient supplement, containing turmeric and apple extracts, chicken essence, and multimineral, on muscle damage after a rugby match

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Scientific title：

a multi-ingredient supplement (MIS), containing turmeric and apple extracts, imidazole-containing dipeptides, and multimineral powder, on markers of muscle damage in collegiate male players following a rugby match

研究课题的正式科学名称简写：

Scientific title acronym：

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：

研究负责人：

Applicant：

Chen-Kang Chang

Study leader：

Chen-Kang Chang

申请注册联系人电话：

Applicant telephone：

+886921572803

研究负责人电话：

Study leader's telephone：

+886921572803

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：

wspahn@seed.net.tw

研究负责人电子邮件：

Study leader's E-mail：

wspahn@seed.net.tw

申请单位网址(自愿提供)：

Study leader's 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：

研究负责人通讯地址：

Applicant address：

16 Sec 1, Shuan-Shih Rd, Taichung, Taiwan

Study leader's address：

16 Sec 1, Shuan-Shih Rd, Taichung, Taiwan

申请注册联系人邮政编码：

Applicant postcode：

408

研究负责人邮政编码：

Study leader's postcode：

408

申请人所在单位：

Applicant's institution：

myself

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

111-29

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

Name of the ethic committee：

Human Research Ethics Committee, Jen-Ai Hospital, Taichung, Taiwan

伦理委员会批准日期：

Date of approved by ethic committee：

2022/5/23 0:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

Ming-Chi Chang

伦理委员会联系地址：

Contact Address of the ethic committee：

483, Dongrong Rd., Dali Dist., Taichung City, Taiwan

伦理委员会联系人电话：

Contact phone of the ethic committee：

+886424821771

伦理委员会联系人邮箱：

Contact email of the ethic committee：

jahirb@mail.jah.org.tw

研究实施负责（组长）单位：

Primary sponsor：

Lytone Enterprise, Inc.

研究实施负责（组长）单位地址：

Primary sponsor's address：

13F.-1, No. 31-1, Ln. 169, Kangning St, Xizhi Dist, 221 New Taipei City, Taiwan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Source(s) of funding：

Lytone Enterprise, Inc.

研究疾病：

研究疾病代码：

NA

Target disease：

NA

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机交叉对照

randomized controlled trial(cross-over design)

研究所处阶段：

Study phase：

其它

Others

研究目的：

Objectives of Study：

his study aimed to investigate the effect of MIS containing turmeric and apple extracts, imidazole-containing dipeptides, and multimineral powder on muscle damage markers in collegiate athletes following a rugby match. Furthermore, this study also explored the anti-inflammatory and antioxidative effects of this supplement to determine its underlying mechanism.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

The MIS (Lesscramp, Lytone Enterprise, Inc. New Taipei City, Taiwan) contained turmeric and apple extracts, imidazole-containing dipeptides, and multimineral powder, while the placebo did not. Both supplements contained glucose, vitamin C, branched-chain amino acids, yeast extract, glycyrrhizin, orange flavor, citric acid, sodium bicarbonate, polyethylene glycol, and sucralose. Both supplements were formulated in an effervescent tablet. Each tablet contained 1 g of carbohydrate, 0.04 g of protein, 0 g of fat, and 4.2 kcal.

纳入标准：

Inclusion criteria

Male rugby players from a Division I team. participants received regular rugby training for at least 3 years.

排除标准：

Exclusion criteria：

The exclusion criteria included the following: with musculoskeletal injury within 1 month prior to the study or major cardiovascular or metabolic diseases.

研究实施时间：

Study execute time：

从From 2022-02-01

至To      2022-09-30

征募观察对象时间：

Recruiting time：

从From 2022-06-01

至To      2022-06-20

干预措施：

Interventions：

组别：

样本量：

13

Group：

placebo

Sample size：

干预措施：

干预措施代码：

Intervention：

placebo

Intervention code：

组别：

样本量：

13

Group：

MIS

Sample size：

干预措施：

干预措施代码：

Intervention：

multiple-ingredient supplement

Intervention code：

样本总量 Total sample size ： 13

研究实施地点：

Countries of recruitment
and research settings：

国家：

省(直辖市)：

市(区县)：

Country：

China

Province：

Taiwan

City：

Taichung

单位(医院)：

单位级别：

Institution/hospital：

National Taiwan University of Sport

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

指标类型：

次要指标

Outcome：

20-kg loaded countermovement jump

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

16 and 2 days prior to the rugby match

Measure method：

force platform

指标中文名：

指标类型：

主要指标

Outcome：

blood creatine kinase concentration

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

prior to and immediately, 24 h, and 48 h after the rugby match

Measure method：

commercial kit and automatic biochemistry analyzer

指标中文名：

指标类型：

次要指标

Outcome：

reactive agility test

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

16 and 2 days prior to the rugby match

Measure method：

light gates

指标中文名：

指标类型：

次要指标

Outcome：

Zig-Zag change of direction test

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

16 and 2 days prior to the rugby match

Measure method：

light gates

指标中文名：

指标类型：

次要指标

Outcome：

muscle soreness

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

After each training session during the 2-week supplementation period

Measure method：

0-100 mm visual analogue scale

指标中文名：

指标类型：

次要指标

Outcome：

Mood status

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Immediately before, 1 week after, and 2 weeks after supplementation

Measure method：

Brunel Mood Scale

指标中文名：

指标类型：

次要指标

Outcome：

blood concentration of tumor necrosis factor-alpha

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

prior to and immediately, 24 h, and 48 h after the rugby match

Measure method：

ELISA

指标中文名：

指标类型：

次要指标

Outcome：

Fatigue

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

After each training session during the 2-week supplementation period

Measure method：

Borg 10-point ratings of perceived exertion

指标中文名：

指标类型：

次要指标

Outcome：

40 m sprint

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

16 and 2 days prior to the rugby match

Measure method：

light gates

指标中文名：

指标类型：

次要指标

Outcome：

Sleep quality

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Immediately before, 1 week after, and 2 weeks after supplementation

Measure method：

Pittsburgh sleep quality questionnaire

指标中文名：

指标类型：

次要指标

Outcome：

7. Prone Yo-Yo Intermittent recovery 1 test

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

16 and 2 days prior to the rugby match

Measure method：

pre-recorded audio file

指标中文名：

指标类型：

次要指标

Outcome：

countermovement jump

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

16 and 2 days prior to the rugby match

Measure method：

force platform

指标中文名：

指标类型：

次要指标

Outcome：

6 x 30 m shuttle run

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

16 and 2 days prior to the rugby match

Measure method：

light gates

指标中文名：

指标类型：

次要指标

Outcome：

blood malondialdehyde concentration

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

prior to and immediately, 24 h, and 48 h after the rugby match

Measure method：

ELISA

指标中文名：

指标类型：

次要指标

Outcome：

medicine ball push

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

16 and 2 days prior to the rugby match

Measure method：

4-kg medicine ball

指标中文名：

指标类型：

主要指标

Outcome：

blood lactate dehydrogenase concentration

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

prior to and immediately, 24 h, and 48 h after the rugby match

Measure method：

commercial kit and automatic biochemistry analyzer

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

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：

结束

Completed

年龄范围：

最小 21 岁
Min age years
最大 24 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男性

Male

随机方法（请说明由何人用什么方法产生随机序列）：

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

Pairs of participants with similar playing positions, namely, forwards or backs/scrum half, were randomly allocated to either the MIS or placebo trial. The principal investigator, Chen-Kang Chang, generated the random number (1 or 2).

盲法：

Blinding：

The MIS and placebo supplements were stored in the same package; however, they were assigned with red and blue tags to distinguish them. The supplements were packaged by an independent employee. Neither the research personnel nor the participants knew which trial they were on during the study period. The trials were designated as blue or red during the intervention period. The assignment of each tag to its corresponding supplement was only revealed after all data analyses have been concluded.

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）：

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

The data are available upon request to the principal investigator

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：

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

The data are available upon request to the principal investigator

数据管理委员会：

Data Managemen Committee：

暂未确定

Not yet

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

under review

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