UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059534 |
|---|---|
| Receipt number | R000068096 |
| Scientific Title | Evaluation of the effects of test foods on motor function |
| Date of disclosure of the study information | 2025/10/24 |
| Last modified on | 2025/10/27 18:56:22 |
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Basic information
Public title
Evaluation of the effects of test foods on motor function
Acronym
Evaluation of the effects of test foods on motor function
Scientific Title
Evaluation of the effects of test foods on motor function
Scientific Title:Acronym
Evaluation of the effects of test foods on motor function
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of the test food in improving motor function after 8 weeks of daily intake, using a placebo as a control.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The six-minute walk test
Key secondary outcomes
Body composition measurements, ketone body fractions, free fatty acids, grip strength measurements, 5times sit-to-stand test, knee extension muscle strength measurement values, muscle ultrasound, fatigue VAS, POMS2, Borg Scale
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 | Behavior,custom |
Interventions/Control_1
Supplementation of the test food and exercise over a period of 8 weeks.
Interventions/Control_2
Supplementation of placebo and exercise over a period of 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
| 50 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females from 50 to 75 years of age
(2) Person who can understand the purpose and content of this study and agree in this study
Key exclusion criteria
(1)Subjects who clearly have low percent of body fat.
(2)Subjects who cannot do prescribed resistance exercise.
(3)Subjects who cannot take in the supplement.
(4)Subjects who are chronic conditions who regularly take medication.
(5)Subjects who are suffering from mental disorders, sleep disorders, heart disease, kidney disease, diabetes, or other serious illnesses or metabolic disorders.
(6)With a history of severe illness who the principal investigator determines to be unsuitable for study participation.
(7)With serious current or past medical conditions such as cerebrovascular disease, malignant tumors, immune disorders, thyroid disorders, adrenal disorders, or other metabolic disorders.
(8)Subjects who have experienced dizziness, fainting, or transient visual loss, and for whom the principal investigator has determined participation in the study would be problematic.
(9) Subjects who are treat menopausal disorders.
(10) Subjects with are musculoskeletal disorders that restrict physical activity.
(11) Subjects who are taking medication that affects heart rate.
(12) Subjects who may develop allergies in relation to the study.
(13) Subjects regularly taking pharmaceuticals, quasi-drugs, Kampo medicines, health foods, or over-the-counter drugs, foods for specified health uses, foods with functional claims, nutritional functional foods, etc., that may affect research.
(14) Subjects who regularly consumed health supplements that could potentially affect body fat or muscle function within the three months prior to obtaining consent, or who plan to consume such supplements during the study period.
(15) Shift workers whose shifts extend past midnight or night shift workers.
(16) Subjects with extremely intense exercise habits.
(17) Subjects whose systolic blood pressure is less than 90mmHg.
(18)Subjects who are judged as unsuitable for the study by the principal investigator or the investigator for other reason.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kosei |
| Middle name | |
| Last name | Tsukamoto |
Organization
Rohto Pharmaceutical Co., Ltd
Division name
Internal Medicine and Functional Food Development Division
Zip code
544-8666
Address
1-8-1 Tatsuminishi, Ikuno-ku, Osaka Shi, Osaka
TEL
06-6758-9848
kouseit@rohto.co.jp
Public contact
Name of contact person
| 1st name | Chiharu |
| Middle name | |
| Last name | Goto |
Organization
EP Mediate Co., Ltd.
Division name
Development Department Trial Planning Section
Zip code
162-0814
Address
Acropolis Tokyo, 6-29 Shinogawacho, Shinjuku, Tokyo
TEL
09015364583
Homepage URL
goto.chiharu069@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Rohto 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo)
Tel
03-6452-2712
epmd_fd-erb@eps.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
社会福祉法人新栄会 滝野川病院（東京都）、医療法人財団 同仁記念会 明和病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 24 | 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
| 2025 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 26 | 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 | 10 | Month | 24 | Day |
Last modified on
| 2025 | Year | 10 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068096
