UMIN-CTR Clinical Trial

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
Institute	Morinaga & CO., LTD.
Institute
Department

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	Open public recruiting
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 06 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 02 Month 18 Day

Link to view the page
URL(English)	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

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