UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060800 |
|---|---|
| Receipt number | R000069556 |
| Scientific Title | Effects of consumption of the test food on the low back: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2026/03/02 |
| Last modified on | 2026/03/02 09:51:43 |
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Basic information
Public title
Effects of consumption of the test food on the low back
Acronym
Effects of consumption of the test food on the low back
Scientific Title
Effects of consumption of the test food on the low back: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Effects of consumption of the test food on the low back
Region
| Japan |
Condition
Condition
Healthy Japanese
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 low back in healthy Japanese.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. The measured value of the total score in the Japan low back pain evaluation questionnaire (JLEQ) at 12 weeks after intervention (12w)
Key secondary outcomes
1. The measured values of severity of low back pain, 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 at 12w
2. The measured values of the Japanese Orthopaedic Association (JOA) score, the subjective symptoms score, the objective findings score, the activities of daily living score, and the bladder function score at 12w
3. Improvement rate of JOA score
4. The measured value of Visual Analogue Scale (VAS) at 12w
5. Individuals who experienced adverse events
6. Individuals whose values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at screening
7. Physical measurements, urine test, peripheral blood test
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
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
The test food
Interventions/Control_2
Duration: 12 weeks
Placebo
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 are concerned about the low back
6. Individuals who had no osteophytes on X-ray examination
7. Individuals whose JLEQ score is bad
Key exclusion criteria
1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction
2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)
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 are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
5. Individuals who are taking or using medications (including herbal medicines) and supplements
6. Individuals who are allergic to medicines and foods related to the test product, particularly those who are allergic to salmon or gelatin
7. Individuals who are pregnant, lactating, or planning to become pregnant during this study
8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study
9. Individuals who usually use (e.g., glucosamine hydrochloride, chondroitin, collagen peptide, hyaluronic acid, or DHA / EPA) that affect the joint
10. Individuals who plan to start exercise that put intense stress on the low back
11. Individuals who are judged as ineligible to participate in this study by the physician
Target sample size
60
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
ICHIMARU PHARCOS Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
ICHIMARU PHARCOS 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 | 03 | Month | 02 | 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 | 02 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
If other exploratory analyses are deemed necessary, statistical analyses such as stratified analyses and subgroup analyses may be performed.
Management information
Registered date
| 2026 | Year | 03 | Month | 02 | Day |
Last modified on
| 2026 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069556
