UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023388 |
|---|---|
| Receipt number | R000026949 |
| Scientific Title | Verification of the efficacy of collagen peptide for the purpose of flail-Locomotive Syndrome Prevention |
| Date of disclosure of the study information | 2016/07/31 |
| Last modified on | 2017/02/03 08:43:40 |
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Basic information
Public title
Verification of the efficacy of collagen peptide for the purpose of flail-Locomotive Syndrome Prevention
Acronym
Effect of collagen peptide intake for the purpose of locomotive syndrome prevention
Scientific Title
Verification of the efficacy of collagen peptide for the purpose of flail-Locomotive Syndrome Prevention
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Igase Michiya |
Organization
Ehime University
Division name
Department of Geriatrics and Neurology, Ehime University Graduate School of Medicine
Zip code
Address
Shitsukawa454, Toon city, Ehime
TEL
089-960-5851
migase@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Igase Michiya |
Organization
Ehime University
Division name
Department of Geriatrics and Neurology, Ehime University Graduate School of Medicine
Zip code
Address
Shitsukawa454, Toon city, Ehime
TEL
089-960-5851
Homepage URL
migase@m.ehime-u.ac.jp
Sponsor or person
Institute
Nitta Gelatin Inc. Peptide Division.
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2016 | Year | 06 | Month | 15 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026949
