UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verification of the efficacy of collagen peptide for the purpose of flail-Locomotive Syndrome Prevention
Title of the study (Brief title)	Effect of collagen peptide intake for the purpose of locomotive syndrome prevention
Region	Japan

Condition
Condition	Healthy person who aware of the initial knee joint pain
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In this study, we carry out the randomized, double-blind study in order to reaffirm the effect on the joint and bone and muscle with a low molecular weight of collagen peptide.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	The extent of the knee joint pain in the VAS score
Key secondary outcomes	Impact muscle mass / visceral fat area in the exercise-associated, dominant arm of grip strength, eye-opening one leg Standing time, bone density, pulse wave velocity, and KSS score.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intervention: Intake 2.5g collagen peptide for 120 days
Interventions/Control_2	Control: Intake 2.5g whey for 120 days
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Who diagnosed with ever knee osteoarthritis, who are undergoing treatment. Who has been found gelatin allergy. Who is known dairy allergy.
Key exclusion criteria	Who diagnosed with ever knee osteoarthritis, who are undergoing treatment. Who has been found gelatin allergy. Who is known dairy allergy.
Target sample size	76

Research contact person
Name of lead principal investigator	Igase Michiya
Organization	Ehime University
Division name	Department of Geriatrics and Neurology, Ehime University Graduate School of Medicine
Address	Shitsukawa454, Toon city, Ehime
TEL	089-960-5851
Email	migase@m.ehime-u.ac.jp

Public contact
Name of contact person	Igase Michiya
Organization	Ehime University
Division name	Department of Geriatrics and Neurology, Ehime University Graduate School of Medicine
Address	Shitsukawa454, Toon city, Ehime
TEL	089-960-5851
Homepage URL
Email	migase@m.ehime-u.ac.jp

Sponsor
Institute	Nitta Gelatin Inc. Peptide Division.
Institute
Department

Funding Source
Organization	Nitta Gelatin Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	愛媛大学医学部付属病院（愛媛県）（Ehime University, Ehime）

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 15 Day
Anticipated trial start date	2016 Year 07 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 07 Month 29 Day
Last modified on	2017 Year 02 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026949