UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057316 |
|---|---|
| Receipt number | R000065521 |
| Scientific Title | Study on the confirmation of aging effects from supplement intake (preliminary test) |
| Date of disclosure of the study information | 2025/03/20 |
| Last modified on | 2025/09/16 10:00:19 |
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Basic information
Public title
Study on the confirmation of aging effects from supplement intake (preliminary test)
Acronym
Study on the confirmation of aging effects from supplement intake (preliminary test)
Scientific Title
Study on the confirmation of aging effects from supplement intake (preliminary test)
Scientific Title:Acronym
Study on the confirmation of aging effects from supplement intake (preliminary test)
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the effects and safety of continuous intake of research food for 23 weeks on aging indicator.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Aging indicator
Key secondary outcomes
Energy production-related indicators, questionnaire, hematologic test, blood biochemistry test
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
Intake the research food twice a day, 10 pieces for 23 consecutive 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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females from 20 to 80 years of age.
(2) Subjects who fully understand the purpose and content of this study and voluntarily agree to participate in the study.
Key exclusion criteria
(1) Subjects who plan to become pregnant or breastfeed during the study period.
(2) Subjects who have or have a history of cancer.
(3) Subjects who have had abnormalities in clinical laboratory values or cardiopulmonary function, and are judged to have a problem participating in the study.
(4) Subjects who may develop allergies in relation to the study.
(5) Subjects whose physical measurements, physical examination values, and clinical examination values before the start of intake were significantly out of the reference range.
(6) Subjects who work in shifts, work late at night, and have an irregular daily rhythm.
(7) Subjects who have participated in another study within a month prior to the present study, or who plan to participate in other studies.
(8) Subjects who are judged to be unsuitable as subjects based on the answers to the background survey.
(9) 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 | Takayuki |
| Middle name | |
| Last name | Kumei |
Organization
FRACORA Co., Ltd.
Division name
R&D Department
Zip code
160-0023
Address
1-22-2, Nishishinjuku, Shinjuku-ku, Tokyo
TEL
070-1216-5446
takayuki.kumei@fracora.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Yamamichi |
Organization
EP Mediate Co., Ltd.
Division name
Development Department Trial Planning Section
Zip code
162-0821
Address
Kagurazaka AK Bldg., 1-8 Tsukudocho, Shinjuku-ku, Tokyo
TEL
090-4821-1099
Homepage URL
yamamichi.shingo578@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
FRACORA 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
医療法人社団 慶幸会 東新宿クリニック (東京都)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | 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
55
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
Completed
Date of protocol fixation
| 2025 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 09 | 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 | 03 | Month | 17 | Day |
Last modified on
| 2025 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065521
