UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058628 |
|---|---|
| Receipt number | R000066558 |
| Scientific Title | Verification of the effect of oral intake of base supplements on health checkup values |
| Date of disclosure of the study information | 2025/07/30 |
| Last modified on | 2025/07/29 11:30:31 |
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Basic information
Public title
General supplement intake test
Acronym
General supplement intake test
Scientific Title
Verification of the effect of oral intake of base supplements on health checkup values
Scientific Title:Acronym
Testing of base supplements
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of whether taking supplements improves health checkup results
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Health check value
Key secondary outcomes
Experience Survey Results
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test foods A-1 (1 capsule/day), A-2 (4 tablets/day), and A-3 (4 capsules/day) were taken continuously for 24 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy person
Key exclusion criteria
Those currently undergoing treatment for an illness (including taking medicines), those who need treatment for an illness, or those who are scheduled to undergo treatment in the future, and those who are deemed inappropriate by the principal investigator
Target sample size
654
Research contact person
Name of lead principal investigator
| 1st name | Yoshiharu |
| Middle name | |
| Last name | Matahira |
Organization
Sunsho Pharmaceutical Co.,Ltd.
Division name
Research and Development Division
Zip code
418-0019
Address
Innovation Center 12, Nanryo, Fujinomiya, Shizuoka
TEL
0544-25-1484
y.matahira@sunsho.co.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Kurono |
Organization
Sunsho Pharmaceutical Co., Ltd.
Division name
Product Development Section
Zip code
418-0019
Address
Innovation Center 12, Nanryo, Fujinomiya, Shizuoka
TEL
0544-25-1484
Homepage URL
masahiro.kurono@sunsho.co.jp
Sponsor or person
Institute
Sunsho Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Sunsho Pharmaceutical 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
Sunsho Pharmaceutical Co., Ltd. Ethics Review Board
Address
1468 Atsuhara, Fuji, Shizuoka
Tel
0545-73-0610
takahiro.fukumoto@sunsho.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
| 2025 | Year | 07 | Month | 30 | 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 | 06 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | 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 | 07 | Month | 29 | Day |
Last modified on
| 2025 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066558
