UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000056585 |
|---|---|
| Receipt number | R000064490 |
| Scientific Title | Undenatured Type II Collagen Long-term Intake Study |
| Date of disclosure of the study information | 2026/04/30 |
| Last modified on | 2025/09/16 09:59:12 |
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Basic information
Public title
Undenatured Type II Collagen Long-term Intake Study
Acronym
Undenatured Type II Collagen Long-term Intake Study
Scientific Title
Undenatured Type II Collagen Long-term Intake Study
Scientific Title:Acronym
Undenatured Type II Collagen Long-term Intake Study
Region
| Japan |
Condition
Condition
N/A (healthy adults)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the improvement in knee joint and the associated motor functions following the oral administration of the study foods for 12 weeks continuously in healthy male and female
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knee joint passive range of motion
Key secondary outcomes
WOMAC, JKOM, VAS for knee discomfort (at wake up, when walking, when ascending stairs, when descending stairs, when squatting, when sitting upright, when standing up after sitting upright, when standing up from a chair, when picking up something that has fallen on the floor), JLEQ, VAS for lower back discomfort (at wake up, when walking, when ascending stairs, when descending stairs, when squatting, when sitting upright, when standing up after sitting upright, when standing up from a chair, when rolling over, when stretching the lower back, when twisting the lower back, while in crouching or forward-leaning position, when picking up something that has fallen on the floor), and the motor function (10-meter walking test (the duration and number of steps for normal and fastest walks) and stair-climbing tests)
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
Intake the test food (capsules containing undenatured type II collagen) for 12 weeks
Interventions/Control_2
Intake the control food (capsules without undenatured type II collagen) for 12 weeks
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
1)Japanese male and female aged 20 to <75 years at the time of obtaining the consent for trial participation
2)Healthy participants who are not currently receiving treatment for any serious disease
3)Participants who do not have OA or RA but have discomfort in their knees
4)Participants with JKOM pain VAS 20mm or more (preferably 50mm or less)
5)Participants who can visit the designated facility on the scheduled visit date
6)Participants who provided their consent in writing after having fully understood the purpose and content of the trial
Key exclusion criteria
1)Participants with OA (knee OA , grade II or higher according to the KL classification), RA , and gout
2)Participants with gait velocity of 1.0m/s or more at 10m walk (maximal velocity walk) during the pretest
3)Participants with body mass index 25.0 or more at the time of preliminary examination
4)Participants undergoing outpatient treatment for knee arthralgia
5)Participants who have difficulty in participating in the study due to liver, kidney, and heart diseases, respiratory disorder, endocrine disorder, metabolic disorder, neuropathy, consciousness disorder, diabetes mellitus (according to the criteria established by the Japanese Diabetes Association), and other diseases
6)Participants with a history of cardiovascular disease
7)Participants who regularly use drugs or health foods/supplements (including food for specified uses, food with function claims, and food with nutrient function claims) that may affect this study (but who can stop using them at the time informed consent was obtained is not applicable)
8)Participants with allergies related to test foods (collagen)
9)Participants who have weakness or deterioration in physical condition due to previous blood sampling
10)Participants who have donated blood (200mL or more) from the month before the start of the study to the start of the study or who are scheduled to donate blood during the study period
11)Participants participating in other clinical trials or who are within 4 weeks of completion of the study
12)Participants with alcohol polydipsia and persons who smoke excessively
13)Participants who have extremely irregular eating habits
14)Participants who do not agree with the purpose of the test, which was explained in advance
15)Participants who are determined by the principal investigator as not suitable for participation in this study
Target sample size
88
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Shiojima |
Organization
Ryusendo Co., Ltd.
Division name
President and CEO
Zip code
1710021
Address
1-5-3 Nishi-ikebukuro, Toshima-ku, Tokyo 171-0021, Japan
TEL
0339858346
y.shiojima@ryusendo.co.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Takahashi |
Organization
Ryusendo Co., Ltd.
Division name
Development Division
Zip code
1710021
Address
1-5-3 Nishi-ikebukuro, Toshima-ku, Tokyo 171-0021, Japan
TEL
03-3985-8346
Homepage URL
m.takahashi@ryusendo.co.jp
Sponsor or person
Institute
Kyowa Trial Co., Ltd.
Institute
Department
Personal name
Yoshimichi Kozai
Funding Source
Organization
Ryusendo 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
Institutional Review Board of Yamazaki Otolaryngology Medical Corporation Clinic
Address
14-1-16 Kita 11-jo Nishi, Chuo-ku, Sapporo-shi, Hokkaido 060-0011, Japan
Tel
011-757-3387
s-ito@kyowa-t.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
| 2026 | Year | 04 | Month | 30 | 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
| 2024 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 27 | Day |
Last modified on
| 2025 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000064490
