UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048282 |
|---|---|
| Receipt number | R000054861 |
| Scientific Title | Intervention study of the effect of collagen peptide intake on motor function |
| Date of disclosure of the study information | 2025/10/31 |
| Last modified on | 2022/07/05 15:20:46 |
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Basic information
Public title
Intervention study of the effect of collagen peptide intake on motor function
Acronym
Collagen peptide and muscle
Scientific Title
Intervention study of the effect of collagen peptide intake on motor function
Scientific Title:Acronym
Collagen peptide and muscle
Region
| Japan |
Condition
Condition
Frail
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In Japan, which has entered an aging society, it is said that long-term care prevention = frailty prevention = locomotive prevention, and attention is being paid to maintaining and improving the quantity and quality of exercise equipment, especially muscles. It is also important for athletes to maintain and improve muscle mass and quality. We planned a study that oral intake of collagen affects the maintenance and improvement of muscle mass and quality, and maintains and improves motor function. There are already reports of human studies showing that oral collagen intake improves motor function under some limited conditions. There are also reports on the mechanism of action of collagen peptide on muscle cells at the cellular level. From these facts, there is sufficient legitimacy for the science and safety of this study. On the other hand, since the human test for locomotorium lasts for a long period of several months, by adding vitamins to the placebo group and having them take both dietary education and exercise programs, they became a placebo group. Reduce the disadvantages of this.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body composition with In body
3 months after the start of administration
Key secondary outcomes
Body movement survey by locomotive degree check
3 months after the start of administration
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
3 months, collagen peptide 10g / day with vitamin C,
vitamin E, every day
Interventions/Control_2
3 months, placebo(vitamin C, vitamin E), every day
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Students, faculty and staff belonging to Josai University and residents of Tokigawa Town
Key exclusion criteria
(1) Those who have food allergies (gelatin)
(2) Those who use a cardiac pacemaker
(3) Persons with kidney disease
(4) Persons who need assistance in exercising or eating
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Mano |
Organization
Josai University
Division name
Faculty of Pharmacy and Pharmaceutical Sciences
Zip code
350-0295
Address
Keyakidai 1-1, Sakado, Saitama
TEL
049-271-7246
h-mano@josai.ac.jp
Public contact
Name of contact person
| 1st name | Katsumata |
| Middle name | |
| Last name | Kimiko |
Organization
Josai University
Division name
Experiment Center Office
Zip code
350-0295
Address
Keyakidai 1-1, Sakado, Saitama
TEL
049-271-7735
Homepage URL
kkimiko@stf.josai.ac.jp
Sponsor or person
Institute
Josai University
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
Josai University Life Science / Medical Research Ethics Review Board for Humans
Address
Keyakidai 1-1, Sakado, Saitama
Tel
049-271-7735
kkimiko@stf.josai.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2021-15
Org. issuing International ID_1
Josai University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | 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 | 07 | Month | 05 | Day |
Last modified on
| 2022 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054861
