UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057069 |
|---|---|
| Receipt number | R000065236 |
| Scientific Title | Effect of food-derived ingredients on neck, shoulder, and low back discomfort |
| Date of disclosure of the study information | 2025/02/19 |
| Last modified on | 2025/08/21 09:54:08 |
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Basic information
Public title
Effect of food-derived ingredients on neck, shoulder, and low back discomfort
Acronym
Effect of food-derived ingredients
Scientific Title
Effect of food-derived ingredients on neck, shoulder, and low back discomfort
Scientific Title:Acronym
Effect of food-derived ingredients
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of the food-derived ingredients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
JLEQ scores after 8 weeks of food-derived ingredients (analysis of covariance with pre-measurement scores as covariate)
Key secondary outcomes
VAS for neck, shoulder, and lower back
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
NO
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Take tablets containing food-derived ingredients once daily for 8 weeks.
Interventions/Control_2
Take placebo tablets once daily for 8 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
| 30 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants must be Japanese, aged 30-59, and meet either of the following criteria (n = 80):
1 Participants who experience stiffness and tension in the neck and shoulders, as well as in the lower back (n = 40 for 2 groups):
Experience stiffness, tension, or pain in the neck and shoulders at least twice a week for more than 3 months.
A VAS (Visual Analogue Scale) score of 40 or higher for discomfort (stiffness, tension, pain) in the neck and shoulders (with 100 being the maximum).
Experience stiffness, tension, or pain in the lower back at least twice a week for more than 3 months.
A VAS score of 40 or higher for discomfort (stiffness, tension, pain) in the lower back (with 100 being the maximum).
A score of 20 or higher on the Japanese Lumbar Evaluation Questionnaire (JLEQ).
2 Participants who experience stiffness and tension in the neck and shoulders, as well as neuropath ic pain in the lower back (n = 40 for 2 groups):
Experience stiffness, tension, or pain in the neck and shoulders at least twice a week for more than 3 months.
A VAS score of 40 or higher for discomfort (stiffness, tension, pain) in the neck and shoulders (with 100 being the maximum).
Experience stiffness, tension, or pain in the lower back at least twice a week for more than 3 months.
A VAS score of 40 or higher for discomfort (stiffness, tension, pain) in the lower back (with 100 being the maximum).
A score of 20 or higher on the Japanese Lumbar Evaluation Questionnaire (JLEQ).
A score of 6 or higher on the Neuropathic Pain Questionnaire, with preference given to those with higher scores.
Key exclusion criteria
1. Individuals currently attending a hospital to treat stiffness, tension, or pain in the neck, shoulders, or lower back, or those using oral or topical medications (including patches) for such purposes.
2. Individuals who have undergone surgical procedures on the neck, shoulders, or lower back.
3. Individuals diagnosed by a physician with a condition related to stiffness, tension, or pain in the neck, shoulders, or lower back.
4. Individuals with hyperuricemia and a history of gout attacks.
5. Individuals with a history of rheumatoid arthritis.
6. Individuals taking health foods or supplements (such as vitamins) related to relieving stiffness or tension.
7. Individuals engaging in activities (such as massage, chiropractic, or acupuncture) that might affect the evaluation of effectiveness.
8. Individuals with serious diseases affecting the liver, kidneys, heart, lungs, digestive system, blood, endocrine system, or metabolism.
9. Individuals diagnosed with cardiovascular-related diseases such as arteriosclerosis, angina, or arrhythmia, or with mental health disorders such as depression.
10. Individuals who have suffered severe musculoskeletal injuries (such as fractures, tendon ruptures, or muscle strains) within one year prior to study participation.
11. Individuals using canes, braces, or corsets.
12. Individuals with impairments affecting the measurement of musculoskeletal function.
13. Pregnant women, those who may be pregnant, nursing mothers, or those planning to become pregnant during the study period.
14. Individuals participating in other clinical trials involving pharmaceuticals or foods, or those planning to participate in another study during the cooperation period of this study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Minegishi |
Organization
Kao Corporation
Division name
Human Health Care Research Lab.
Zip code
321-3497
Address
2606, Akabane, Ichikai-Machi, Haga-Gun, Tochigi, 321-3497, JAPAN
TEL
+81-70-3296-8156
minegishi.yoshihiko@kao.com
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Sugita |
Organization
Kao Corporation
Division name
Human Health Care Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-70-3296-8204
Homepage URL
sugita.satoshi@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao 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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.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 | 02 | 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
73
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | 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 | 02 | Month | 19 | Day |
Last modified on
| 2025 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065236
