UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059738 |
|---|---|
| Receipt number | R000068220 |
| Scientific Title | Study on the Effects of Test Food Intake on Shoulder Discomfort, Shoulder Load, Scapular Range of Motion, and Shoulder Blood Flow - Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparative Trial - |
| Date of disclosure of the study information | 2025/11/11 |
| Last modified on | 2025/11/06 09:20:09 |
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Basic information
Public title
Study on the Effects of Test Food Intake on Shoulder Discomfort, Shoulder Load, Scapular Range of Motion, and Shoulder Blood Flow
- Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparative Trial -
Acronym
Study on the Effects of Test Food Intake on Shoulder Discomfort, Shoulder Load, Scapular Range of Motion, and Shoulder Blood Flow
Scientific Title
Study on the Effects of Test Food Intake on Shoulder Discomfort, Shoulder Load, Scapular Range of Motion, and Shoulder Blood Flow
- Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparative Trial -
Scientific Title:Acronym
Study on the Effects of Test Food Intake on Shoulder Discomfort, Shoulder Load, Scapular Range of Motion, and Shoulder Blood Flow
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effects of continuous consumption of the test food on shoulder function assessment and to examine its safety.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Shoulder Function Assessment Index
Key secondary outcomes
*Secondary Evaluation Items
1)Patient-Reported Shoulder 36 (V1.3)
2)Muscle Hardness Measurement
*Safety Evaluation Items
1)Blood Pressure/Pulse Rate
2)Weight/Body Fat Percentage/BMI
3)Hematological Tests
4)Blood Biochemical Tests
5)Urinalysis
6)Physician Interview/Adverse Event Assessment
7)Daily Activity Log
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 a test food (3 tablets in a day; 8 weeks).
Interventions/Control_2
Oral ingestion of a placebo food (3 tablets in a day; 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Males and females aged 30 years or older but under 65 years at the time of obtaining consent to participate in the trial.
2) Individuals in good health with no chronic physical conditions.
3) Individuals who frequently experience shoulder strain or stiffness in daily life.
4) Individuals who have received sufficient explanation regarding the purpose and content of this trial, possess the capacity to consent, voluntarily volunteer to participate after fully understanding, and can provide written consent to participate in this trial.
5) Individuals who can attend the designated examination date and undergo the examination.
6) Individuals deemed suitable for participation in this trial by the principal investigator.
Key exclusion criteria
1) Individuals using medical products.
2) Individuals suffering from shoulder joint disorders or similar conditions.
3) Individuals with a history or current condition of serious impairment affecting the eyes, digestive organs, liver, kidneys, heart, lungs, blood, or mental health.
4) Individuals who used a drug to treat a disease in the past 1 month.
5) Individuals whose BMI is over 30 kg/m2.
6) Individuals with drug and food allergies.
7) Individuals who currently have, or have had within the past three months, a habit of regularly consuming functional foods, health foods, or supplements that claim to improve blood flow or reduce fatigue, or that contain ingredients that could potentially affect test results; as well as individuals who plan to consume such products during the test period.
8) Individuals whose average weekly pure alcohol consumption exceeds 40 g/day for men and 20 g/day for women.
9) Individuals with possible changes of life style during the test period.
10) Individuals engaged in shift work or night work involving regular fluctuations in working hours.
11) Individuals who have a smoking habit.
12) Individuals who are or are possibly pregnant, or are lactating.
13) Individuals unable to restrict the use of massage, osteopathy, chiropractic, acupuncture, or the application of heat packs and hot compresses during exam periods.
14) Individuals who participated in other clinical studies in the past 3 months.
15) Individuals who are or whose family is engaged in healthy or functional foods.
16) Individuals who are unable to follow instructions from the study supervisor or who judged inappropriate for the study by the principal.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Masakazu |
| Middle name | |
| Last name | Kobayashi |
Organization
Kobayashi Pharmaceutical Co., Ltd.
Division name
Research and Development Headquarters, Healthcare Development Department, Food Development Group
Zip code
567-0057
Address
1-30-3 Toyokawa, Ibaraki-shi, Osaka
TEL
080-3452-9955
masa-kobayashi@kobayashi.co.jp
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kobayashi Pharmaceutical 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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
jimukyoku@tes-h.co.jp
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 | 11 | Month | 11 | 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 | 10 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 24 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 19 | 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 | 11 | Month | 11 | Day |
Last modified on
| 2025 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068220
