UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062134 |
|---|---|
| Receipt number | R000071091 |
| Scientific Title | Effect of 4-week glucosamine supplementation on urinary cartilage degradation markers in street dancers (a double-blind, randomized, parallel-group comparative study) |
| Date of disclosure of the study information | 2026/07/06 |
| Last modified on | 2026/07/03 16:56:02 |
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Basic information
Public title
Effect of 4-week glucosamine supplementation on urinary cartilage degradation markers in street dancers (a double-blind, randomized, parallel-group comparative study)
Acronym
Effect of Glucosamine Intake on Urinary Cartilage Degradation Markers in Street Dancers
Scientific Title
Effect of 4-week glucosamine supplementation on urinary cartilage degradation markers in street dancers (a double-blind, randomized, parallel-group comparative study)
Scientific Title:Acronym
Effect of Glucosamine Intake on Urinary Cartilage Degradation Markers in Street Dancers
Region
| Japan |
Condition
Condition
knee pain
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of whether glucosamine reduces urinary markers of cartilage degradation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in urinary CTX-II concentration
Key secondary outcomes
Changes in JKOM and JLEQ
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
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Taking glucosamine supplements
Interventions/Control_2
Taking tablets containing neither glucosamine nor mucopolysaccharides.
Interventions/Control_3
Administration of the vehicle alone
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Individuals aged 18 years or older at the time of obtaining consent
2) Individuals who practice street dance on a regular basis (3 days or more per week)
3) Individuals with no abnormalities or discomfort in their joints
4) Individuals not currently undergoing treatment for internal medical conditions or orthopedic disorders (at the start of the study)
5) Individuals who have received an explanation of the study details, have fully understood them, and have provided written consent to participate
Key exclusion criteria
Patients meeting any of the following criteria will be excluded from the study:
1) Individuals with food allergies to crustaceans (shrimp or crab), pork, chicken, soybeans, or gelatin.
2) Individuals determined to require further medical evaluation by the participating physician (orthopedic surgeon) based on the questionnaire, JKOM, and JLEQ.
3) Individuals testing positive (1+ or higher on a test strip) for urinary glucose, protein, or occult blood in a urinalysis.
4) Women who are pregnant, breastfeeding, or potentially pregnant.
5) Individuals otherwise deemed unsuitable by the principal investigator or participating physician.
Target sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Yoshida |
Organization
Gunma University
Division name
Medical Education and and Development
Zip code
371-8511
Address
3-39-22 Showa-machi, Maebashi City, Gunma Prefecture
TEL
027-220-8017
ayossie10@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Yoshida |
Organization
Gunma University
Division name
Medical Education and and Development
Zip code
371-8511
Address
3-39-22 Showa-machi, Maebashi City, Gunma Prefecture
TEL
027-220-8017
Homepage URL
ayossie10@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
ORIHIRO 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
Gunma University Hospital Clinical Research Review Board
Address
3-39-15 Showa-machi, Maebashi City, Gunma Prefecture
Tel
027-220-8740
irb-jimukk-ciru@ml.gunma-u.ac.jp
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 | 07 | Month | 06 | 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
| 2026 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 02 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2026 | Year | 07 | Month | 03 | Day |
Last modified on
| 2026 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071091
