UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042901 |
|---|---|
| Receipt number | R000048415 |
| Scientific Title | Long-term intake test of collagen-containing foods |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2022/07/01 15:54:16 |
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Basic information
Public title
Long-term intake test of collagen-containing foods
Acronym
Long-term intake test of collagen-containing foods
Scientific Title
Long-term intake test of collagen-containing foods
Scientific Title:Acronym
Long-term intake test of collagen-containing foods
Region
| Japan |
Condition
Condition
N/A (healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of improving the movement of knee joints and the accompanying motor function when healthy men and women are continuously ingested the test food for 12 weeks
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knee passive range of motion measurement
Key secondary outcomes
1)JKOM
2)VAS of discomfort in the knee (when resting, walking, climbing stairs)
3)10m walking (normal speed, maximum speed, number of steps)
4)Stair climbing test
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 (Collagen-containing food) for 12 weeks
Interventions/Control_2
Intake the control food 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 males and females between the ages of 20 and less than 75 at the time of obtaining consent to participate in the test
2)Healthy persons who are not currently being treated for any serious illness
3)Those who are not patients with OA (gonarthrosis) or rheumatism but have discomfort in the knees
4)Those with JKOM pain VAS of 20 mm or more (preferably 50 mm or less)
5)JKOM III those with a high score in daily living conditions (Q9-18)
6)Those who can visit the designated facility on the scheduled visit date
7)Those who fully understand the purpose and content of this test and have agreed in writing
Key exclusion criteria
1)Patients with OA (gonarthrosis, grade II or higher in KL classification), RA and/or goat
2)Those who have difficulty to participate in this study because of conditions i.e., liver, kidney, or cardiac disease, breathing, endocrinology, metabolism, nervous, or conscious disorder, diabetes (determined by JDA), and other diseases
3)Those with history of cardiovascular diseases
4)Those who use medicines, health foods and supplements (including "Food for specified health uses", "Foods with function claims" and "Food with nutrient function claims") constantly, excepting those who can stop them at taking of informed consent
5)Those who have allergies related to test food (collagen)
6)Previous experience of poor or worsened health after giving a blood sample
7)Blood donations 200 mL or more in the month before the trial or have plans for making a blood donation 200 mL or more during the trial period
8)Participation in another clinical trial, whether ongoing or within the last four weeks
9)Heavy drinkers and smokers
10)Extremely irregular dietary patterns
11)Those with a BMI of 25.0 or higher at the time of pre-examination
12)Those with a walking speed of 1.6 m / sec or more when walking 10 m (maximum walking speed)
13)Those who do not wish to provide their consent to the details of the trial explained to them in advance
14)Those who judged that examination responsible doctor is not appropriate for this study participation
Target sample size
60
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
171-0021
Address
1-5-3 Nishi-ikebukuro, Toshima-ku, Tokyo 171-0021, Japan
TEL
03-3985-8346
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
171-0021
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
Akanuma Surgery Clinic
Clinical Trials Division
Institute
Department
Personal name
Funding Source
Organization
Ryusendo Co., Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Akanuma Surgery Clinic
Address
6-14-1 Ishiyama 2-jo, Minami-ku, Sapporo-shi, Hokkaido 005-0842, Japan
Tel
011-591-1777
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
| 2022 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Unpublished due to the protocol including the intellectual property rights
Publication of results
Published
Result
URL related to results and publications
https://www.tandfonline.com/doi/full/10.1080/07315724.2021.2024466
Number of participants that the trial has enrolled
60
Results
A significant difference was observed in the primary outcome.
Results date posted
| 2022 | Year | 07 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy Japanese adult
Participant flow
60 participants completed and 58 subjects were incorporated into the analyses.
Adverse events
No adverse effect reported
Outcome measures
Knee passive range of motion measurement
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2021 | Year | 04 | 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
| 2021 | Year | 01 | Month | 05 | Day |
Last modified on
| 2022 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048415
