UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059385 |
|---|---|
| Receipt number | R000067921 |
| Scientific Title | Exploratory Study on the Anti-Aging Effects of a Test Food - Single-Arm, Open-Label Trial - |
| Date of disclosure of the study information | 2025/12/07 |
| Last modified on | 2025/10/14 11:24:13 |
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Basic information
Public title
Exploratory Study on the Anti-Aging Effects of a Test Food
Acronym
Exploratory Study on the Anti-Aging Effects of a Test Food
Scientific Title
Exploratory Study on the Anti-Aging Effects of a Test Food
- Single-Arm, Open-Label Trial -
Scientific Title:Acronym
Exploratory Study on the Anti-Aging Effects of a Test Food
- Single-Arm, Open-Label Trial -
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of the test food on biological age, as measured by the Epigenetic Clock, as well as its impact on other aging-related parameters and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Biological age assessment using the Epigenetic Clock test
Key secondary outcomes
-Aging biomarkers (including NAD+, DHEA-S, 8-OHdG)
-Questionnaire on aging-related factors
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants will take six capsules of the test food twice daily, in the morning and evening, with water or lukewarm water.
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
| 40 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy adults aged 40 to under 70 at the time of consent
(2) Individuals who have received a thorough explanation of the study, fully understand its purpose and procedures, voluntarily wish to participate, and provide written informed consent
Key exclusion criteria
(1) Regular use (>=3 times/week) of specified health foods, functional foods, or supplements, or inability to discontinue such products even if used less than 3 times/week (e.g., NMN, vitamins A/B/C/D/E, DHA/EPA, sesamin, protein, etc.)
(2) Currently receiving pharmacological treatment at the time of consent (excluding as-needed medications)
(3) Excessive alcohol consumption (average >60g/day per week)
(4) Difficulty with blood sampling
(5) Unable to visit the study site
(6) History or current serious disease of the heart, liver, kidneys, digestive system, etc.
(7) Have received a vaccination within 1 month prior to the start of the study, or have a planned vaccination during the study period
(8) Allergies to medications or foods
(9) Participation in another clinical study of drugs or health foods, within 4 weeks after completion of such a study, or plans to participate in another study after consenting to this one
(10) Blood component or 200 mL whole blood donation within 1 month before study start
(11) 400 mL whole blood donation within 3 months before study start
(12) Total blood drawn within 12 months prior to study start, including planned study draws, exceeds 1200 mL
(13) Determined unsuitable for participation by the principal investigator
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Yasumasa |
| Middle name | |
| Last name | Yamada |
Organization
UHA Mikakuto Co., Ltd.
Division name
Representative director
Zip code
540-0016
Address
4-12 Kanzaki-cho Chuo-ku Osaka
TEL
06-6767-6050
asanot@uha-mikakuto.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
UHA Mikakuto 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
Institutional Review Board
Address
1-14-26-204,Miharadai,Nerimaku,Tokyo
Tel
080-7345-7947
info@okutoeru.com
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
| 2025 | Year | 12 | Month | 07 | 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 | 13 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 03 | 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 | 14 | Day |
Last modified on
| 2025 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067921
