UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060089 |
|---|---|
| Receipt number | R000068720 |
| Scientific Title | Evaluation of the effects of test foods on motor function |
| Date of disclosure of the study information | 2025/12/20 |
| Last modified on | 2025/12/18 22:52:55 |
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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 efficacy of the test food in improving motor function and its safety during 12 weeks of continuous intake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sports Performance Assessment
Key secondary outcomes
Body composition measurements, Ketone body, Free fatty acids, Lactate, Creatine, Lactate dehydrogenase (LDH), Myoglobin, Cortisol,Muscle ultrasound, Functional Movement Screen (FMS)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Supplementation of the test food over a period of 12 weeks
Interventions/Control_2
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
(1) Healthy males from 18 years or older at the time of consent.
(2) Person who can understand the purpose and content of this study and agree in this study.
Key exclusion criteria
(1) Subjects who are unable to ingest the study food (supplement) or who have allergies to any of its ingredients.
(2) Subjects who are currently receiving medical treatment-such as outpatient care or medication-or who are judged by the study-site physician to have a significant medical history requiring exclusion.
(3) Subjects who have repeatedly experienced discomfort or adverse physical reactions during past blood draws.
(4) Subjects who have donated blood components or donated 200 mL or more of whole blood within one month prior to the initial examination date, or who plan to do so during the study period.
(5) Subjects who are currently participating in another clinical trial, or who participated in another clinical trial within two months prior to the initial examination date.
(6) Subjects who regularly use pharmaceuticals, quasi-pharmaceuticals, Kampo medicines, or health foods (including supplements, over-the-counter drugs,Foods for Specified Health Uses, and foods with functional claims) that may influence the study, or who have continuously consumed health foods likely to affect body composition or muscle function within the three months prior to providing consent.
(7) Subjects with markedly irregular dietary habits or lifestyles that may substantially influence the study results.
(8) Subjects who are judged unsuitable as study participants based on the results of preliminary examinations or lifestyle questionnaires.
(9) Subjects who are otherwise judged unsuitable for participation in this study by the principal investigator or the study-site physician.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Kuwahara |
Organization
Rohto Pharmaceutical Co.,Ltd.
Division name
Internal Medicine and Functional Food Development Division
Zip code
544-8666
Address
1-8-1,Tatsumi-nishi,Ikuno-ku, Osaka 544-8666, Japan
TEL
06-6758-9848
kuwahra@rohto.co.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Kuwahara |
Organization
Rohto Pharmaceutical Co.,Ltd.
Division name
Internal Medicine and Functional Food Development Division
Zip code
544-8666
Address
1-8-1,Tatsumi-nishi,Ikuno-ku, Osaka 544-8666, Japan
TEL
06-6758-9848
Homepage URL
kuwahra@rohto.co.jp
Sponsor or person
Institute
Rohto Pharmaceutical 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
Japan
Other related organizations
Co-sponsor
MG PHARMA Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Rohto Pharmaceutical Co.,Ltd. Clinical Research Ethics Review Committee
Address
1-8-1, Tatsumi-nishi, Ikuno-ku, Osaka 544-8666, Japan
Tel
06-6758-1231
rohtoirb@rohto.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
MTXスポーツ・関節クリニック（東京都）、アローズラボ（東京都）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 20 | 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 | 18 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 22 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 10 | 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 | 12 | Month | 15 | 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=R000068720
