UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060115 |
|---|---|
| Receipt number | R000068741 |
| Scientific Title | Effect of food-derived ingredients on physical discomfort. |
| Date of disclosure of the study information | 2025/12/18 |
| Last modified on | 2025/12/18 10:26:16 |
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Basic information
Public title
Effect of food-derived ingredients on physical discomfort.
Acronym
Effect of food-derived ingredients on physical discomfort.
Scientific Title
Effect of food-derived ingredients on physical discomfort.
Scientific Title:Acronym
Effect of food-derived ingredients on physical discomfort.
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 on physical discomfort.
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 discomfort
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
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Take low-dose capsules containing food-derived ingredients once daily for 8 weeks.
Interventions/Control_2
Take medium-dose capsules containing food-derived ingredients once daily for 8 weeks.
Interventions/Control_3
Take high-dose capsules containing food-derived ingredients once daily for 8 weeks.
Interventions/Control_4
Take placebo capsules once daily for 8 weeks.
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
Japanese adults aged 30-59 years.
Experiencing discomfort in the neck or shoulders, as well as the lower back, at least twice per week for 3 months or longer.
Visual analog scale (VAS) score of 40 or higher for neck or shoulder discomfort, and VAS of 40 or higher for low-back discomfort.
Japan Low back pain Evaluation Questionnaire (JLEQ) score of 20 or higher.
Key exclusion criteria
1. Those who are currently visiting a hospital to treat discomfort in the neck, shoulders, or lower back, or who used oral or topical medications (including medicated patches) for such discomfort within 1 month prior to study participation.
2. Those who underwent procedures that could affect efficacy assessment (e.g., massage, chiropractic/osteopathic bodywork, acupuncture) within 1 month prior to study participation.
3. Those who took health foods or supplements related to discomfort (e.g., B vitamins) within 1 month prior to study participation.
4. Those who have undergone surgery on the neck, shoulders, or lower back.
5. Those diagnosed by a physician with a disorder related to neck, shoulder, or lower back discomfort.
6. Those with a history of diabetes, rheumatoid arthritis, shingles, or hyperuricemia.
7. Those with serious diseases of the liver, kidneys, heart, lungs, gastrointestinal tract, blood, endocrine system, or metabolism.
8. Those who have been diagnosed with cardiovascular diseases such as arteriosclerosis, angina, or arrhythmia, or with psychiatric disorders such as depression.
9. Those who sustained severe musculoskeletal injuries (e.g., fracture, tendon rupture, muscle strain) within 1 year prior to study participation.
10. Those who use a cane, supports/braces, or a corset/back brace.
11. Those for whom musculoskeletal measurements would be difficult or hindered.
12. Those with excessively high intake of coffee, green tea, or black tea.
13. Pregnant women; those who may be pregnant; breastfeeding women; and those who intend to become pregnant during the study period.
14. Those who participated in other clinical trials of drugs or foods within 1 month prior to study participation, or who plan to participate in another study during this study.
15. Those who have difficulty taking capsules.
16. Those with a score of 6 or higher on a neuropathic pain questionnaire.
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 | 12 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Association analysis between skin properties and blood xxxx.
Management information
Registered date
| 2025 | Year | 12 | Month | 18 | Day |
Last modified on
| 2025 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068741
