UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058369 |
|---|---|
| Receipt number | R000066727 |
| Scientific Title | An exploratory study on the effects of continuous intake of a test food on muscle strength, muscle mass, and walking ability in middle-aged and older adults. -Randomized, placebo-controlled, double-blind, parallel group study- |
| Date of disclosure of the study information | 2025/07/04 |
| Last modified on | 2026/07/06 13:22:03 |
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Basic information
Public title
An exploratory study on the effects of continuous intake of a test food on muscle strength, muscle mass, and walking ability in middle-aged and older adults.
-Randomized, placebo-controlled, double-blind, parallel group study-
Acronym
An exploratory study on the effects of continuous intake of a test food on muscle strength, muscle mass, and walking ability in middle-aged and older adults.
Scientific Title
An exploratory study on the effects of continuous intake of a test food on muscle strength, muscle mass, and walking ability in middle-aged and older adults.
-Randomized, placebo-controlled, double-blind, parallel group study-
Scientific Title:Acronym
An exploratory study on the effects of continuous intake of a test food on muscle strength, muscle mass, and walking ability in middle-aged and older adults.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to confirm the physical performance of middle-aged and older men and women who have no difficulty exercising, after 12 weeks of continuous consumption of test foods.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motor function tests
Key secondary outcomes
Physical examination, QOL Questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of active food for 12 weeks
Interventions/Control_2
Intake of placebo food for 12 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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Males and females aged of 50-69 years
2)Participants who are judged by the investigator or sub-investigator not to have difficulty exercising
3)Participants who can visit on schedule days
4)Participants who recognize the object and contents of the study and submit the written informed consent
Key exclusion criteria
1)Participants with a history of serious cardiac disease (e.g. heart failure, myocardial infarction, myocarditis)
2)Participants with a history or current history of serious disease (liver, kidney, cardiovascular, gastrointestinal, pulmonary, hematologic, metabolic)
3)Participants who have experienced syncope or transient visual loss
4)Participants with musculoskeletal disorders (except for those who are deemed eligible to participate by the study investigator)
5)Participants taking medications that affect heart rate
6)Participants who received medication treatment or surgery due to serious illness or injury within 1 month from the start of this study and who have difficulty with daily living or exercise
7)Individuals who regularly consume, or plan to consume during the study, health foods or supplements that may affect the study
8)Heavy drinker (over 40g alcohol/day)
9)Smokers (over 21 smoking/day)
10)Participants who regularly engage in strenuous physical activity
11)Participants who have allergy related to the test foods
12)Participants who are already participating in other clinical trials, those who plan to participate during this study period, and those within one month after the completion of the trial in which they participated
13)Participants who are ineligible due to physician's judgment
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Ikuo |
| Middle name | |
| Last name | Fukuhara |
Organization
Fukuhara Clinic
Division name
Hospital director
Zip code
061-1351
Address
3-1-15 Shimamatsuhigashi-machi, Eniwa, Hokkaido, Japan
TEL
0123-36-8029
i-feniwa@gray.plala.or.jp
Public contact
Name of contact person
| 1st name | Toyotada |
| Middle name | |
| Last name | Ashino |
Organization
Trans Genic Inc.
Division name
Clinical Research Department
Zip code
061-1405
Address
452-1 Toiso,Eniwa,Hokkaido,Japan
TEL
0123-34-0412
Homepage URL
toyotada.ashino@transgenic.co.jp
Sponsor or person
Institute
Taiyo Kagaku Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Taiyo Kagaku 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 Corporation Jikokai Fukuzumi Internal Medicine Clinic Clinical Trial Review Committee
Address
1-2-5 Fukuzumi-2jo, Toyohira-ku, Sapporo, Hokkaido, Japan
Tel
011-836-3531
shibata@jkkai.or.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
株式会社トランスジェニック 恵庭研究所（北海道）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 04 | 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
46
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 06 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
| 2026 | Year | 02 | Month | 13 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 04 | Day |
Last modified on
| 2026 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066727
