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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

Registration number：

ITMCTR2023000036

Date of Last Refreshed on：

2023-08-28

Date of Registration：

2023-08-28

Registration Status：

Retrospective registration

Public title：

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

English Acronym：

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

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Chen-Kang Chang

Study leader：

Chen-Kang Chang

Applicant telephone：

+886921572803

Study leader's telephone：

+886921572803

Applicant Fax：

Study leader's fax：

Applicant E-mail：

wspahn@seed.net.tw

Study leader's E-mail：

wspahn@seed.net.tw

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

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

Study leader's address：

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

Applicant postcode：

408

Study leader's postcode：

408

Applicant's institution：

myself

Approved by ethic committee：

Approved No. of ethic committee：

111-29

Approved file of Ethical Committee：

View

Name of the ethic committee：

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

Date of approved by ethic committee：

2022/5/23 0:00:00

Contact Name of the ethic committee：

Ming-Chi Chang

Contact Address of the ethic committee：

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

Contact phone of the ethic committee：

+886424821771

Contact email of the ethic committee：

jahirb@mail.jah.org.tw

Primary sponsor：

Lytone Enterprise, Inc.

Primary sponsor's address：

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

Secondary sponsor：

Source(s) of funding：

Lytone Enterprise, Inc.

NA

Target disease：

NA

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(cross-over design)

Study phase：

Others

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.

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.

Inclusion criteria

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

Exclusion criteria：

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

Study execute time：

From 2022-02-01

To      2022-09-30

Recruiting time：

From 2022-06-01

To      2022-06-20

Interventions：

13

Group：

placebo

Sample size：

Intervention：

placebo

Intervention code：

13

Group：

MIS

Sample size：

Intervention：

multiple-ingredient supplement

Intervention code：

Total sample size ： 13

Countries of recruitment
and research settings：

Country：

China

Province：

Taiwan

City：

Taichung

Institution/hospital：

National Taiwan University of Sport

Level of the institution：

University

Outcomes：

Outcome：

20-kg loaded countermovement jump

Type：

Secondary indicator

Measure time point of outcome：

16 and 2 days prior to the rugby match

Measure method：

force platform

Outcome：

blood creatine kinase concentration

Type：

Primary indicator

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

Outcome：

reactive agility test

Type：

Secondary indicator

Measure time point of outcome：

16 and 2 days prior to the rugby match

Measure method：

light gates

Outcome：

Zig-Zag change of direction test

Type：

Secondary indicator

Measure time point of outcome：

16 and 2 days prior to the rugby match

Measure method：

light gates

Outcome：

muscle soreness

Type：

Secondary indicator

Measure time point of outcome：

After each training session during the 2-week supplementation period

Measure method：

0-100 mm visual analogue scale

Outcome：

Mood status

Type：

Secondary indicator

Measure time point of outcome：

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

Measure method：

Brunel Mood Scale

Outcome：

blood concentration of tumor necrosis factor-alpha

Type：

Secondary indicator

Measure time point of outcome：

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

Measure method：

ELISA

Outcome：

Fatigue

Type：

Secondary indicator

Measure time point of outcome：

After each training session during the 2-week supplementation period

Measure method：

Borg 10-point ratings of perceived exertion

Outcome：

40 m sprint

Type：

Secondary indicator

Measure time point of outcome：

16 and 2 days prior to the rugby match

Measure method：

light gates

Outcome：

Sleep quality

Type：

Secondary indicator

Measure time point of outcome：

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

Measure method：

Pittsburgh sleep quality questionnaire

Outcome：

7. Prone Yo-Yo Intermittent recovery 1 test

Type：

Secondary indicator

Measure time point of outcome：

16 and 2 days prior to the rugby match

Measure method：

pre-recorded audio file

Outcome：

countermovement jump

Type：

Secondary indicator

Measure time point of outcome：

16 and 2 days prior to the rugby match

Measure method：

force platform

Outcome：

6 x 30 m shuttle run

Type：

Secondary indicator

Measure time point of outcome：

16 and 2 days prior to the rugby match

Measure method：

light gates

Outcome：

blood malondialdehyde concentration

Type：

Secondary indicator

Measure time point of outcome：

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

Measure method：

ELISA

Outcome：

medicine ball push

Type：

Secondary indicator

Measure time point of outcome：

16 and 2 days prior to the rugby match

Measure method：

4-kg medicine ball

Outcome：

blood lactate dehydrogenase concentration

Type：

Primary indicator

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

Collecting sample(s)
from participants：

Sample Name：

blood

Tissue：

Fate of sample 

Destruction after use

Note：

Completed

21
Min age years
24
Max age years

Recruiting status：

Participant age：

Gender：

Male

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).

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.

IPD sharing：

No

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

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

Data Managemen Committee：

Not yet

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

under review

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