UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059194 |
|---|---|
| Receipt number | R000067681 |
| Scientific Title | Evaluation of the efficacy and safety of test foods for older adults |
| Date of disclosure of the study information | 2026/03/31 |
| Last modified on | 2026/03/09 09:34:02 |
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Basic information
Public title
Evaluation of the efficacy and safety of test foods for older adults
Acronym
Evaluation of the efficacy and safety of test foods for older adults
Scientific Title
Evaluation of the efficacy and safety of test foods for older adults
Scientific Title:Acronym
Evaluation of the efficacy and safety of test foods for older adults
Region
| Japan |
Condition
Condition
N/A
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess the effectiveness and safety of the test food.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
6-minute walk test
Key secondary outcomes
grip strength, measurement of blood markers, cognitive assessment score
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
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of the test food for 48 weeks with an exercise intervention
Interventions/Control_2
Oral intake of the placebo food for 48 weeks with an exercise intervention
Interventions/Control_3
Oral intake of the test food for 48 weeks without an exercise intervention
Interventions/Control_4
Oral intake of the placebo food for 48 weeks without an exercise intervention
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
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Males or females aged 50-79 years who had provided informed consent.
2) Ability to perform the physical activities required for the conduct of the study.
3) Ability to provide their own smartphone and email address, and to download and use the program/app necessary for the study on that smartphone.
4) Ability to understand the study purpose and procedures, and participate voluntarily.
Key exclusion criteria
1)A total HDS-R score of 20 or less at screening.
2)Difficulty with color discrimination or other problems that interfere with cognitive testing.
3)Unable to complete web questionnaires.
4)Current, prior, or suspected dementia, psychiatric, neurological, or cerebrovascular disease.
5)Current menopausal disorder.
6)Taking medications that could affect the study results.
7)Have undergone cognitive testing within 3 months before screening, or plan non-study cognitive testing during the study.
8)Having a disorder affecting motor function and currently receiving pharmacological treatment.
9)Regularly engaging in activities that influence motor function.
10)Absolute contraindication to exercise therapy or exercise stress testing.
11)Unable to perform measurements or exercise due to injury or illness.
12)Engage regularly in moderate-to-vigorous exercise totaling 3 hours or more per week.
13)Planned unavoidable intense exercise during the study.
14)Have major surgery planned during the study or are awaiting major surgery.
15)Current or past serious illnesses (e.g., malignant neoplasm, diabetes, liver, kidney, or heart disease).
16)Are at risk of developing an allergy related to the study.
17)Regularly using dietary supplements or medications containing the study's active ingredient.
18)Regularly consuming supplements intended to affect cognition, motor, or immune function.
19)Will have multiple occurrences of irregular lifestyle during the study.
20)Plan to change lifestyle habits during the study unrelated to participation in this study.
21)Regular heavy alcohol consumption.
22)Smoke 21 or more cigarettes per day.
23)Participation in another clinical trial within 1 month before consent, or planned during the study.
24)Pregnant or breastfeeding, or plan pregnancy during the study.
25)Judged unsuitable as a study subject based on responses to questionnaire or screening.
26)Any other reason the principal investigator considers the candidate unsuitable for participation.
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | |
| Last name | Uchida |
Organization
Morinaga & Co., Ltd.
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama
TEL
045-571-6140
h-uchida-ji@morinaga.co.jp
Public contact
Name of contact person
| 1st name | Shinpei |
| Middle name | |
| Last name | Kawakami |
Organization
Morinaga & Co., Ltd.
Division name
Health Science and Research Center, R&D institute
Zip code
230-8504
Address
2-1-1, Shimosueyoshi, Tsurumi-ku, Yokohama
TEL
045-571-6140
Homepage URL
s-kawakami-jf@morinaga.co.jp
Sponsor or person
Institute
Morinaga & Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Morinaga & 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
nakajima.megumi888@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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 31 | 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 | 09 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 30 | 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 | 09 | Month | 25 | Day |
Last modified on
| 2026 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067681
