UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055421 |
|---|---|
| Receipt number | R000063144 |
| Scientific Title | Evaluation of the Effect of Test Food on Reducing Feeling of Lower Back Pain |
| Date of disclosure of the study information | 2025/03/31 |
| Last modified on | 2025/03/10 16:57:28 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the Effect of Test Food on Reducing Feeling of Lower Back Pain
Acronym
Evaluation of the Effect of Test Food on Reducing Feeling of Lower Back Pain
Scientific Title
Evaluation of the Effect of Test Food on Reducing Feeling of Lower Back Pain
Scientific Title:Acronym
Evaluation of the Effect of Test Food on Reducing Feeling of Lower Back Pain
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effect of test food on reducing feeling of lower back pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
JLEQ
Key secondary outcomes
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
Oral ingestion of the test food for 12 weeks
Interventions/Control_2
Oral ingestion of the placebo food 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
| 74 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Japanese males and females aged 40-74 years when informed consent.
2) Individuals with feelings of lower back pain on a daily basis and who are judged by an orthopedic surgeon as not requiring immediate treatment.
3) Individuals who have received enough explanation and understood about this study, and who can obtain informed consent.
4) Individuals who do not suffer from specified disease and who do not receive medical treatment, medication, or treatment and judged appropriate for the study by the principal.
5) Individuals with a BMI >= 18.5 and <=29.9
Key exclusion criteria
Individuals
1) using medical products.
2) who have a history of serious hepatopathy, kidney damage, heart disease, lung and blood disease.
3) who have a history of serious gastrointestinal disease.
4) who used or applied a drug for treatment of disease in the past 1 month.
5) who have joint pain due to rheumatism or gout.
6) who have undergone or need lower back surgery.
7) who have a history of lumbar fracture, acute low back pain, intervertebral disk herniation, or spinal stenosis.
8) who have received treatment of block injection in the lower back within 1 year, or will receive it during this test period.
9) whose BMI is < 18.5 or >= 30
10) who have an irregular work pattern or perform physical labor.
11) who engage in strenuous exercise.
12) who regularly engage in activities that may affect the efficacy evaluation.
13) who are heavy alcohol drinker.
14) who regularly use a cane, a supporter of the low back or a corset.
15) who regularly use drugs (including external medicine) or ingest health-promoting foods, foods for specified health uses, health foods, or supplements that have the function of improving joints and muscles in the past 3 months or will use or ingest them during the test period.
16) who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements containing ingredients of the test food in the past 3 months or will ingest them during the test period.
17) who participated in other clinical studies in the past 4 weeks, or will participate during this test period.
18) who are allergic to foods or medicines.
19) who are a smoker.
20) who are or are possibly pregnant, or are lactating.
21) who were hospitalized and received treatment in the past 6 months.
22) who will change life style during the test period.
23) who judged inappropriate for this study by the principal investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Iemoto |
Organization
Morinaga & Co., Ltd.
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama
TEL
045-571-6140
n-iemoto-jb@morinaga.co.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Saito |
Organization
Morinaga & Co., Ltd.
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa
TEL
045-571-6140
Homepage URL
e-saito-jd@morinaga.co.jp
Sponsor or person
Institute
Morinaga & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Morinaga & 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
Shiba Palace Clinic Ethics Review Committee
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho
shiba_palace@s-palace-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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 31 | 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
Completed
Date of protocol fixation
| 2024 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2024 | Year | 09 | Month | 04 | Day |
Last modified on
| 2025 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063144
