UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046438 |
|---|---|
| Receipt number | R000052989 |
| Scientific Title | The efficacy evaluation of test food on knee discomfort and mobility function: a randomized, double-blind, placebo-controlled trial |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/10/06 09:51:10 |
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Basic information
Public title
The efficacy evaluation of test food on knee discomfort and mobility function.
Acronym
The efficacy evaluation of test food on knee discomfort and mobility function.
Scientific Title
The efficacy evaluation of test food on knee discomfort and mobility function: a randomized, double-blind, placebo-controlled trial
Scientific Title:Acronym
The efficacy evaluation of test food on knee discomfort and mobility function.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of test food on knee discomfort and motility function.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The level of the Japan orthopaedic association Score (JOA) and mobility function tests. Amount of change in JOA and mobility function tests before and after intake.
Key secondary outcomes
The level of Japanese knee osteoarthritis measure (JKOM) and visual analog scale (VAS). Amount of change in JKOM and VAS before and after intake. Safety assessment. Statistical analysis of the level and the amount of change in JOA, mobility function tests, JKOM and VAS by the Kellgren-Lawrence grading system.
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
Interventions/Control_2
Placebo food
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
| 30 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy males and females aged 30 to 74 years old who felt discomfort or pain of the knee.
2. Subjects who are determined by the investigator to be unnecessary to receive outpatient care for knee.
3. Subjects who got adequate explanation about the purpose and details of the examination, have the capacity to consent, voluntarily participate in understanding, and agree to participate in the examination in writing.
Key exclusion criteria
1. Subjects who are under treatment, have a history, or are suspected to have rheumatoid arthritis.
2. Subjects who are under treatment or determined by the investigator to need receiving for articular diseases.
3. Subjects with history of surgical therapy (artificial joint) on knees.
4. Subjects who continuously use compress, topical cream, and/or analgesic agent etc. on knee region.
5. Subjects who have injury of semi-lunar disc or the other knee joint disease.
6. Subjects who received the surgery for chronic knee pain in the past.
7. Subjects undergoing treatment for serious chronic diseases such as hepatic disorder, renal disorder, cardiovascular disorder, cerebrovascular disorder, respiratory disorder.
8. Subjects who are unable to stop taking medications, supplements or functional foods that affect the knee joint during the study period.
9. Subjects with allergies to food ingredients contained in the test food.
10. Subjects who hope for pregnancy in the study period, pregnant women, lactating women.
11. Subjects who donated blood of over 200 mL in the past 12 weeks.
12. Subjects who had participated in a study involving the consumption of other foods or drugs or the tests to apply cosmetics and medicines within 1 month retrospectively from the time of consent. Subjects who wish to participate in other studies while participating in this study.
13. Subjects who are judged as unsuitable for the study by the investigator for other reasons.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Kobuna |
Organization
Kobuna Orthopedics Clinic
Division name
Director
Zip code
371-0813
Address
311-2 Gokan-machi, Maebashi-shi, Gunma
TEL
027-261-7600
info@kobunaseikei.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Sales 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
Fujifilm Corporation
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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gunma
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000052989
Publication of results
Published
Result
URL related to results and publications
https://www.pieronline.jp/content/article/0386-3603/50110/2037
Number of participants that the trial has enrolled
160
Results
The JOA score, stair climb test, six-minute walk test, JKOM score and VAS were significantly improved by the ingestion of test supplements.
Results date posted
| 2023 | Year | 10 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy males and females aged 30 to 74 years old who felt discomfort or pain of the knee.
Participant flow
Enrolled (n=160)
Completed (n=160)
Analysed (n=160)
Adverse events
No adverse effects were observed in the test supplements.
Outcome measures
JOA, JKOM, VAS, mobility function tests
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 16 | 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 | 12 | Month | 22 | Day |
Last modified on
| 2023 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052989
