UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059067 |
|---|---|
| Receipt number | R000067044 |
| Scientific Title | Safety evaluation of excessive intake of the test foods containing plant extract A |
| Date of disclosure of the study information | 2025/09/16 |
| Last modified on | 2025/09/12 11:29:23 |
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Basic information
Public title
Safety evaluation of excessive intake of the test foods containing plant extract
Acronym
Safety evaluation of excessive intake of plant extract
Scientific Title
Safety evaluation of excessive intake of the test foods containing plant extract A
Scientific Title:Acronym
Safety evaluation of excessive intake of plant extract A
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of excessive intake of the test food containing Plant extract.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events, physical measurement (body weight and body mass index), physical examination (blood pressure, heart rate, body temperature), and laboratory tests (hematology test, blood biochemistry test, urine test), Doctor's interview (Pre-intake, 2 weeks and 4 weeks after intake, and 2 weeks after the end of intake of test food)
Key secondary outcomes
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
Oral intake of the test foods containing plant extract for 4 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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Japanese Men and women between the ages of 20 and 64 at the time of obtaining informed consent
2) Healthy adults
Key exclusion criteria
1) Participants currently undergoing treatment, taking medication, or visiting a hospital for any disease.
2) Participants who are pregnant, breastfeeding, or who may become pregnant during the study period.
3) Participants who have an alcohol dependence.
4) Participants who are allergic to ingredients related to the test food.
5) Participants who are participating in other clinical studies.
6) Participants who have a history of serious hepatic or kidney damage, heart disorders.
7) Participants with a history of or current hepatitis.
8) Participants with severe anemia.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Aida |
Organization
Nippn Corporation
Division name
Central Research Laboratory
Zip code
243-0041
Address
5-1-3 Midorigaoka, Atsugi, Kanagawa, Japan
TEL
046-222-6963
kaida@nippn.co.jp
Public contact
Name of contact person
| 1st name | Kou |
| Middle name | |
| Last name | Masuda |
Organization
SOUKEN Co., Ltd.
Division name
Secretariat
Zip code
105-0013
Address
3F Daiwa A Hamamatsucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo
TEL
03-5408-1555
Homepage URL
jimukyoku@mail.souken-r.com
Sponsor or person
Institute
Nippn Corporation
Institute
Department
Personal name
Funding Source
Organization
Nippn Corporation
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
Shiba Palace Clinic Ethics Review Committee
Address
6F Daiwa A Hamamatsucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, Japan
Tel
03-5408-1599
jimukyoku@mail.souken-r.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 | 09 | Month | 16 | 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 | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 25 | 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 | 12 | Day |
Last modified on
| 2025 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067044
