UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060905 |
|---|---|
| Receipt number | R000069697 |
| Scientific Title | Evaluation of the Effects of Research Food on Bone and Joint Health |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/12 11:49:48 |
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Basic information
Public title
Evaluation of the Effects of Research Food on Bone and Joint Health
Acronym
Evaluation of the Effects of Research Food on Bone and Joint Health
Scientific Title
Evaluation of the Effects of Research Food on Bone and Joint Health
Scientific Title:Acronym
Evaluation of the Effects of Research Food on Bone and Joint Health
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The efficacy and safety of the research food for bones and joints will be evaluated by having healthy men and women consume it over time. This will involve measuring and assessing subjective symptoms related to joint pain, along with blood data such as joint markers and inflammation markers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Japanese Knee Osteoarthritis Measure (JKOM)
Key secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Japanese version, Joint markers; MMP-3, TIP-1, CTX-II, Inflammation markers; CRP, IL-6, IL-10
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
Test food intake (12 weeks)
Interventions/Control_2
Placebo food intake (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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Healthy Japanese men and women aged 18 to 29 at the time of consent to participate in the trial.
2) Individuals not currently receiving medication for any medical condition.
3) Individuals able to consistently consume the test food throughout the trial period and strictly adhere to all precautions.
4) BMI between 20 and 27 inclusive.
5) Individuals able to submit dietary records (main staple foods and snacks for 3 days at the start and end of the trial).
6) Individuals deemed suitable for trial participation by the trial director and principal investigator.
Key exclusion criteria
1) Individuals experiencing allergic symptoms such as hay fever and undergoing treatment
2) Individuals suffering from or with a history of severe cardiovascular disorders, hepatic dysfunction, renal dysfunction, respiratory disorders, endocrine disorders, or metabolic disorders
3) Individuals with a history of severe disease requiring ongoing medication
4) Individuals at risk of developing allergies related to the trial
5) Individuals participating in another clinical trial at the start of this trial, or who have participated in one within the past month.
6) Individuals who are pregnant, breastfeeding, or plan to become pregnant during the trial period.
7) Other individuals deemed unsuitable as subjects by the trial investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Mitsutaka |
| Middle name | |
| Last name | Kohno |
Organization
Kyushu Wimen's University
Division name
Faculty of Home Nutrition, Department of Nutrition
Zip code
807-8586
Address
1-1 Jiyugaoka, Yahatanishi, Kitakyushu, Fukuoka, 807-8586, Japan
TEL
0936933125
m-kohno@kwuc.ac.jp
Public contact
Name of contact person
| 1st name | Mitsutaka |
| Middle name | |
| Last name | Kohno |
Organization
Kyushu Wimen's University
Division name
Faculty of Home Nutrition, Department of Nutrition
Zip code
807-8586
Address
1-1 Jiyugaoka, Yahatanishi, Kitakyushu, Fukuoka, 807-8586, Japan
TEL
0936933125
Homepage URL
m-kohno@kwuc.ac.jp
Sponsor or person
Institute
Kyushu Wimen's University
Institute
Department
Personal name
Funding Source
Organization
MEDGAEA JAPAN 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
Kyushu Wimen's University
Address
1-1 Jiyugaoka, Yahatanishi, Kitakyushu, Fukuoka, 807-8586, Japan
Tel
0935933125
m-kohno@kwuc.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 | 04 | Month | 01 | 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 | 01 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 04 | 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 | 03 | Month | 12 | Day |
Last modified on
| 2026 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069697
