UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061971 |
|---|---|
| Receipt number | R000070895 |
| Scientific Title | Effects of consumption of the test food on the discomfort of the joint (of low back, shoulder, and knee) : an open-label study |
| Date of disclosure of the study information | 2026/06/19 |
| Last modified on | 2026/06/19 10:29:04 |
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Basic information
Public title
Effects of consumption of the test food on the discomfort of the joint (of low back, shoulder, and knee) : an open-label study
Acronym
Effects of consumption of the test food on the discomfort of the joint (of low back, shoulder, and knee) : an open-label study
Scientific Title
Effects of consumption of the test food on the discomfort of the joint (of low back, shoulder, and knee) : an open-label study
Scientific Title:Acronym
Effects of consumption of the test food on the discomfort of the joint (of low back, shoulder, and knee)
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food on the discomfort of the joint (of low back, shoulder, and knee) in healthy adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The measured values of the score of Japan Low back pain Evaluation Questionnaire (JLEQ) at 12 weeks after consumption (12w)
Key secondary outcomes
1. The measured values of severity of low back pain measured by Visual Analogue Scale (VAS), low back pain during the past few days, problems in daily living due to low back pain during the past few days, and general health and mental condition during the past month and others of the JLEQ at 12w
2. The measured values of pain intensity in knees measured by VAS, the score, pain and stiffness in knees, activities of daily living, social activities, and general health conditions of the Japanese Knee Osteoarthritis Measure (JKOM) at 12w
3. The measured values of pain, range of motion, muscle strength, general health, ability of daily living, and ability for sports of the Shoulder 36 at 12w
4. Individuals whose responses to each item in the JKOM, JLEQ, and Shoulder 36 improved by one or more scales at 12w
5. The measured values of high sensitivity C-reactive protein (CRP) at 12w
6. Individuals who experienced adverse events
7. Individuals whose values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at screening (Scr)
8. Physical measurements, urinalysis, and peripheral blood test
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test product: Product containing food
Administration:
Consume two tablets twice daily (morning and night, in total four tablets a day) with water.
*If a take is missed, it should be consumed as soon as remembered. The daily take should be consumed within the same day and should not be carried over to the following day.
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Adults
4. Healthy individuals
5. Individuals who have a past medical history of disc herniation
6. Individuals who are judged as eligible to participate in the study by the physician according to the results of X-ray examination at Scr
7. Individuals whose score of JLEQ is bad at Scr
Key exclusion criteria
1. Individuals who are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction
2. Individuals who have an implanted pacemaker or implantable cardioverter defibrillator
3. Individuals who are currently undergoing treatment for any of the following chronic diseases:
cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Individuals who consume Foods for Specified Health Uses or Foods with Functional Claims
5. Individuals who are taking or using medications (including herbal medicines) or supplements
6. Individuals who are allergic to medications or foods related to the test product (particularly citrus fruits)
7. Individuals who are pregnant, lactating, or planning pregnancy during this study
8. Individuals who are deemed unsuitable for participation in this study by the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Yamada |
Organization
Nishi-Arai Ekimae Clinic Ophthalmology and Orthopedics
Division name
Director
Zip code
123-0843
Address
2F Nakazato Bldg., 2-3-13, Nishi-arai sakae-cho, Adachi-ku, Tokyo, Japan
TEL
03-5681-1133
dr_yamada@orthomedico.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
Toyo Sugar Refining Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Toyo Sugar Refining 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
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-clinic.com
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
西新井駅前クリニック眼科整形外科 (東京都)
Nishi-Arai Ekimae Clinic Ophthalmology and Orthopedics (Tokyo, Japan)
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 02 | 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 | 06 | Month | 19 | Day |
Last modified on
| 2026 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070895
