UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061495 |
|---|---|
| Receipt number | R000070361 |
| Scientific Title | Clinical Study for the Evaluation of the Effects of Test Food Consumption on Walking Function |
| Date of disclosure of the study information | 2026/05/11 |
| Last modified on | 2026/05/08 16:08:41 |
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Basic information
Public title
Clinical Study for the Evaluation of the Effects of Test Food Consumption on Walking Function
Acronym
Clinical Study for the Evaluation of the Effects of Test Food Consumption on Walking Function
Scientific Title
Clinical Study for the Evaluation of the Effects of Test Food Consumption on Walking Function
Scientific Title:Acronym
Clinical Study for the Evaluation of the Effects of Test Food Consumption on Walking Function
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Placebo-controlled evaluation of 12-week test food intake on walking function and safety.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
6-minute walking distance
Key secondary outcomes
JKOM score, Grip strength, Timed Up and Go (TUG) test, 5 times sit-to-stand test, VAS (Visual Analog 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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
One packet of the test food daily for 12 weeks
Interventions/Control_2
One packet of placebo food daily 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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy men and women aged 50 to 75 years
(2) Subjects with age-related declines in walking ability
(3) Person who can understand the purpose and content of this study and agree in this study
Key exclusion criteria
(1) Subjects with diseases that may affect the study evaluation, or a history of such conditions
(2) Subjects who experience severe knee or lower-back pain that interferes with daily activities or walking
(3) Subjects who continuously consume health foods related to joints or muscles
(4) Subjects who engage in strenuous exercise that places stress on the joints
(5) Subjects who regularly engage in activities that may affect the evaluation of efficacy
(6) Subjects who may develop allergies in relation to the study
(7) Subjects with conditions requiring continuous medication those currently under treatment , or those with a history of serious illnesses requiring pharmacological treatment
(8) Subjects with serious neurological diseases, malignant tumors, diabetes, liver, kidney, or heart diseases, or a history of such conditions
(9) Subjects with current or past psychiatric disorders, or those strongly suspected of having such conditions
(10) Subjects with markedly abnormal anthropometric, physical, or clinical test values prior to intake
(11) Subjects with irregular lifestyles such as shift work or night work
(12) Subjects with participation in another clinical study within the past month
(13) Subjects who plan to become pregnant or breastfeed during the study period
(14) Subjects who are judged to be unsuitable as subjects based on the answers to the background survey
(15) 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 | Shinji |
| Middle name | |
| Last name | Onose |
Organization
DHC Corporation
Division name
Laboratories, Division 2
Zip code
261-0025
Address
2-42 Hamada, Mihama-ku, Chiba-city, Chiba
TEL
043-275-4811
sonose@dhc.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 Shin-ogawamachi, Shinjuku-ku, Tokyo
TEL
090-1536-4583
Homepage URL
goto.chiharu069@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
DHC Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
メディカルステーションクリニック (Medical station clinic) (東京都)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | 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
| 2026 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 21 | 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 | 05 | Month | 08 | Day |
Last modified on
| 2026 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070361
