UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062093 |
|---|---|
| Receipt number | R000071046 |
| Scientific Title | Effects of consumption of the test food on skeletal muscle in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2026/06/29 |
| Last modified on | 2026/06/29 17:13:18 |
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Basic information
Public title
Effects of consumption of the test food on skeletal muscle in healthy Japanese
Acronym
Effects of consumption of the test food on skeletal muscle in healthy Japanese
Scientific Title
Effects of consumption of the test food on skeletal muscle in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Effects of consumption of the test food on skeletal muscle in healthy Japanese
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 skeletal muscle in healthy Japanese.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Maximum muscle strength of legs at 12 weeks after consumption (12w)
Key secondary outcomes
1. Muscle-to-body-weight ratio of legs and lower-limb age at 12w
2. The 10-meter obstacle course walking at 12w
3. The Timed Up & Go Test at 12w
4. Body weight, body mass index (BMI), lean body mass, fat mass, muscle mass, and grip strength at 12w
5. NOx in blood analysis at 12w
6. Blood analysis at 12w
7. Individuals who experienced adverse events
8. Individuals whose values of urinalysis and peripheral blood test are outside the reference range after intervention despite within the reference range at screening
9. Physical measurements, urinalysis, and 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
Test product: Food
Interventions/Control_2
Duration: 12 weeks
Test product: Placebo food
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Individuals aged 50 or more
4. Healthy individuals
5. Individuals who have low scoring of lower-body extension strength at screening
Key exclusion criteria
1. Individuals who are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction
2. Individuals who have an implanted pacemaker or implantable cardioverter defibrillator
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 diagnosed with sarcopenia or frailty
5. Individuals with a history of conditions or diseases that could potentially affect the assessment of lower limb muscle strength
6. Individuals who engage in at least 60 minutes of exercise per week that elevates their heart rate and causes them to sweat
7. Individuals who engage in strength training (including bodyweight exercises such as push-ups) or activities such as running, walking, cycling, or swimming at least twice a week
8. Individuals who are a smoker
9. Individuals who consume Foods for Specified Health Uses or Foods with Functional Claims
10. Individuals who are taking or using medications (including herbal medicines) or supplements
11. Individuals who cannot regularly take three meals (breakfast, lunch, and dinner) a day
12. Individuals who take dairy products such as milk and cheese at least four times a week
13. Individuals who are allergic to medications or foods related to the test food (particularly gelatin)
14. Individuals who are pregnant, lactating, or planning pregnancy during this study
15. Individuals who are deemed unsuitable for participation in this study by the principal investigator
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Takara |
Organization
Medical Corporation Seishinkai, Takara Clinic
Division name
Director
Zip code
141-0022
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
TEL
03-5793-3623
t-takara@takara-clinic.com
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
J-OIL MILLS, Inc.
Institute
Department
Personal name
Funding Source
Organization
J-OIL MILLS, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Chiba University
Name of secondary funder(s)
Raffinee International Inc.
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
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 | 06 | Month | 29 | 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 | 05 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 29 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 29 | Day |
Last modified on
| 2026 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071046
