UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060008 |
|---|---|
| Receipt number | R000068619 |
| Scientific Title | A Study on the Effects of the Test Food on Knee Joints in Healthy Individuals - A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial - |
| Date of disclosure of the study information | 2025/12/09 |
| Last modified on | 2025/12/05 17:51:15 |
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Basic information
Public title
A Study on the Effects of the Test Food on Knee Joints in Healthy Individuals
Acronym
A Study on the Effects of the Test Food on Knee Joints in Healthy Individuals
Scientific Title
A Study on the Effects of the Test Food on Knee Joints in Healthy Individuals
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial -
Scientific Title:Acronym
A Study on the Effects of the Test Food on Knee Joints in Healthy Individuals
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial -
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of 12 weeks of continuous intake of the test food on knee joints in healthy men and women aged 40 to under 75 who experience knee pain or discomfort but are not undergoing treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
JKOM questionnaire at 12 weeks
Key secondary outcomes
JKOM questionnaire at 4 and 8 weeks
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
Participants will take three capsules of the test food daily for 12 weeks with water or lukewarm water.
Interventions/Control_2
Participants will take three capsules of the placebo food daily for 12 weeks with water or lukewarm water.
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
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Aged 40 to under 75
2. Japanese men and women
3. BMI less than 30.0 kg/m^2
4. Chronic pain or discomfort in one or both knees for at least six months
5. Able to enter electronic diaries via smartphone or PC
6. Fully informed about the study and voluntarily consented electronically
Key exclusion criteria
1. Currently receiving treatment or medication (including Kampo) for any illness
2. Used topical pain medication or analgesics within one month prior to consent or plans to use during the study
3. Under dietary or exercise therapy supervised by a physician
4. History of rheumatoid arthritis, gout, or hyperuricemia
5. Current or past serious illness
6. Receiving treatment at orthopedic pain clinics, chiropractic, osteopathic, or acupuncture clinics
7. History of knee surgery (e.g., artificial joint replacement) or requiring knee surgery
8. Plans for drug therapy for knee joints during the study
9. Intra-articular hyaluronic acid injection within two weeks prior to consent, or steroid injection within three months
10. Knee joint fracture, sprain, or related disease within the past three months
11. Regular use (>=3 times/week) of OTC drugs, quasi-drugs, health foods, supplements, or foods with health claims; participation allowed if discontinued after consent
12. Use of walking aids such as canes or supporters
13. Current or past food or drug allergies
14. Habitual excessive alcohol intake (>=40g pure alcohol/day)
15. Habitual excessive smoking (>=21 cigarettes/day)
16. Shift workers with night shifts
17. Plans to significantly change lifestyle (diet, sleep, exercise) during the study
18. Plans for overseas travel during the study
19. Pregnant, breastfeeding, or planning pregnancy during the study
20. Participation in other clinical trials, within four weeks after completion, or plans to participate after consent
21. Deemed unsuitable by the principal or sub-investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takanori |
| Middle name | |
| Last name | Inai |
Organization
FUJI SANGYO CO.,LTD
Division name
Research and Development Center
Zip code
763-0071
Address
1301, Tamura-cho, Marugame-shi, Kagawa 763-8603 Japan
TEL
0877-25-3221
inai@fuji-sangyo.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
FUJI SANGYO 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.co.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
| 2025 | Year | 12 | Month | 09 | 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
| 2025 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 08 | Day |
Last modified on
| 2025 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068619
