UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059885 |
|---|---|
| Receipt number | R000068489 |
| Scientific Title | A study for the efficacy of test food on knee joint discomfort -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study- |
| Date of disclosure of the study information | 2025/11/26 |
| Last modified on | 2025/11/26 14:21:45 |
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Basic information
Public title
A study for the efficacy of test food on knee joint discomfort
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Acronym
A study for the efficacy of test food on knee joint discomfort
Scientific Title
A study for the efficacy of test food on knee joint discomfort
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Scientific Title:Acronym
A study for the efficacy of test food on knee joint discomfort
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate effects of test food on knee joint discomfort for 12 weeks
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
JOA score
Key secondary outcomes
JKOM,J-KOOS,VAS,knee flexion angle
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food for 12 weeks
Interventions/Control_2
Intake of placebo 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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Males and females aged 40 years old or older at the time of informed consent.
2) Subject with discomfort or pain of knee joints.
3) Subjects diagnosed as grade 0 or I according to the Kellgren- Lawrence grade (KL grade).
4) Subjects whose BMI are less than 30.
5) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
1) have a history of and/or contract rheumatoid arthritis, or are suspected to have rheumatoid arthritis by screening tests.
2) Subjects who are judged suffering from knee osteoarthritis by the investigator.
3) with knee artificial joints, etc.
4) take joint related medicines (such as poultices, liniments, and/or analgesics, etc.) three or more times a week.
5) with knee joint diseases such as chronic joint pain, ligament injury, or meniscal injury, or those currently under treatment for such conditions.
6) have a history of and/or contract serious diseases (eg, liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, metabolic disease and/or joint disease).
7) can't stop using drugs and/or supplements affecting joints during the study period.
8) have allergies to ingredients of test foods.
9) are under treatment for or have a history of drug addiction and/or alcoholism.
10) are pregnant or planning to become pregnant or breastfeed during the study period.
11) had participated in other clinical studies (measurement) within the last one month prior to the current study and/or are planning to participate in other clinical studies (measurement) during the current study.
12) are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Naonori |
| Middle name | |
| Last name | Uchida |
Organization
Q'SAI CO., LTD.
Division name
Sales strategy division, Product planning and development department
Zip code
810-8588
Address
1-1-1 Yakuin, Chuo-ku, Fukuoka-shi, Japan
TEL
092-724-0855
n_uchida@kyusai.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Numazu |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Q'SAI CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17Joutou-machi,Maebashi-shi,Gumma
Tel
027-212-5608
sagawa@mc-connect.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
医療法人公雄会 こぶな整形外科医院（群馬県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | Month | 26 | 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 | 09 | Month | 04 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 13 | 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 | 11 | Month | 26 | Day |
Last modified on
| 2025 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068489
