UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052312 |
|---|---|
| Receipt number | R000059718 |
| Scientific Title | Safety evaluation of excessive intake of supplements containing plant extract |
| Date of disclosure of the study information | 2023/09/27 |
| Last modified on | 2024/04/23 10:35:37 |
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Basic information
Public title
Safety evaluation of excessive intake of supplements containing plant extract
Acronym
Safety evaluation of excessive intake of supplements containing plant extract
Scientific Title
Safety evaluation of excessive intake of supplements containing plant extract
Scientific Title:Acronym
Safety evaluation of excessive intake of supplements containing plant extract
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the safety of excessive intake of the supplement containing plant extract, 5-fold quantity of recommended daily intake.
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), and laboratory tests (hematology test, blood biochemistry test, urine test)
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
Intake of the supplement containing plant extract, 5-fold quantity of recommended daily intake, 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Men and women between the ages of 20 and 64 at the time of obtaining informed consent
2. Subjects who fully understand the objective and content of the study and voluntarily agree to participate in the study.
Key exclusion criteria
1. Subjects who are judged as unsuitable for this study by the investigational doctor based on the results of clinical examination or cardiopulmonary abnormality
2. Subjects who may be at risk of developing allergies in relation to the study
3. Subjects who have a disease requiring habitual medication, subjects with a disease under treatment (excluding dry eye and dental caries treatment), and persons with a history of a serious disease requiring medication treatment
4. Subjects whose screening test physical, physical examination and clinical examination values are significantly out of the reference range
5. Subjects who are participating in other clinical studies
6. Subjects who intend to become pregnant or lactating
7. Subjects who are judged as unsuitable for the study based on the results of background survey
8. who are judged to be unsuitable as research subjects (subjects) based on the results of the screening test
9. Subjects Who judged as unsuitable for the study by the investigator for other reasons
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Sachiyuki |
| Middle name | |
| Last name | Teramoto |
Organization
FANCL Corporation
Division name
Research Institute
Zip code
244-0806
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa, Japan
TEL
045-820-3425
sateramoto@fancl.co.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Yasui |
Organization
EP Mediate Co., Ltd.
Division name
R&D Support Center Foods Department Trial Planning Section 2
Zip code
162-0821
Address
Kagurazaka AK Bldg., 1-8 Tsukudocho, Shinjuku-ku, Tokyo
TEL
080-7710-1158
Homepage URL
yasui.kei475@eps.co.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
Funding Source
Organization
FANCL 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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguroku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@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
| 2023 | Year | 09 | Month | 27 | 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
20
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
| 2023 | Year | 09 | Month | 14 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 14 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 26 | Day |
Last modified on
| 2024 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059718
