UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046626
Receipt number R000053156
Scientific Title Trial of the effect of taking collagen peptide on muscle and joint disorders in athletes
Date of disclosure of the study information 2022/01/17
Last modified on 2022/11/01 11:44:51

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Basic information

Public title

Trial of the effect of taking collagen peptide on muscle and joint disorders in athletes

Acronym

Trial of the effect of taking collagen peptide on muscle and joint disorders in athletes

Scientific Title

Trial of the effect of taking collagen peptide on muscle and joint disorders in athletes

Scientific Title:Acronym

Trial of the effect of taking collagen peptide on muscle and joint disorders in athletes

Region

Japan


Condition

Condition

None

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Trial of the effect of taking collagen peptide on muscle and joint disorders

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Questionnaire, length of the front bent

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of test food (3 months)

Interventions/Control_2

Ingestion of placebo food (3 months)

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

25 years-old >=

Gender

Male and Female

Key inclusion criteria

Athletes belonging to University Athletic Club who are healthy and not suffered from a chronic malady.
Individuals whose written informed consent has been obtained.

Key exclusion criteria

Individuals who have possibility of allergy symptoms onset by the test food and who cause allergic symptoms in foods and medicines.
Individuals who have a habit to ingest collagen peptides on a daily basis.

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Toshihiro
Middle name
Last name Kawama

Organization

Morinaga & CO., LTD.

Division name

R & D institute

Zip code

230-8514

Address

2-1-1, shimosueyoshi, tsurumi-ku, yokohama, kanagawa, 230-8504 Japan

TEL

045-571-2982

Email

t-kawama-jb@morinaga.co.jp


Public contact

Name of contact person

1st name Ryo
Middle name
Last name Tanaka

Organization

Morinaga & CO., LTD.

Division name

R & D institute

Zip code

230-8514

Address

2-1-1, shimosueyoshi, tsurumi-ku, yokohama, kanagawa, 230-8504 Japan

TEL

045-571-2982

Homepage URL


Email

r-tanaka-ba@morinaga.co.jp


Sponsor or person

Institute

Morinaga & CO., LTD.

Institute

Department

Personal name



Funding Source

Organization

Morinaga & CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Non-Profit Organization MINS Institutional Review Board

Address

5-20-9-401,Mita,Minato-ku,Tokyo,Japan

Tel

03-6416-1868

Email

npo-mins@j-irb.com


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2022 Year 01 Month 17 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2022 Year 01 Month 12 Day

Date of IRB

2022 Year 01 Month 12 Day

Anticipated trial start date

2022 Year 02 Month 07 Day

Last follow-up date

2022 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2022 Year 01 Month 13 Day

Last modified on

2022 Year 11 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053156


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name