UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052473 |
|---|---|
| Receipt number | R000059806 |
| Scientific Title | Narcissin Metabolism Test |
| Date of disclosure of the study information | 2023/10/20 |
| Last modified on | 2024/03/25 14:29:56 |
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Basic information
Public title
Narcissin Metabolism Test
Acronym
Narcissin Metabolism Test
Scientific Title
Narcissin Metabolism Test
Scientific Title:Acronym
Narcissin Metabolism Test
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploring the hemodynamics of narcissin metabolism, which are abundant in sea buckthorn
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Isorhamnetin metabolites by blood 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
Narcissin supplements
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those who have given their consent in writing
Key exclusion criteria
1Those who are undergoing treatment for disease or prevention at a medical institution
2Those with mental disabilities
3Those who are judged to be inappropriate to participate in this study
4Pregnant or nursing mothers
5Those with serious food allergies, etc.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kuniyoshi |
| Middle name | |
| Last name | Shimizu |
Organization
Faculty of Agriculture Graduate school of Kyushu University
Division name
Laboratory of Systematic Forest and Forest Products Science
Zip code
819-0395
Address
744 Motooka,Nishiku-Fukuoka,Fukuoka,Japan
TEL
092-802-4675
shimizu.kuniyoshi.381@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Miyazaki |
Organization
Faculty of Agriculture Graduate school of Kyushu University
Division name
Laboratory of Systematic Forest and Forest Products Science
Zip code
815-8540
Address
Room 403, GIC Building, 4-9-1 Shiobara, Minami-ku, Fukuoka City
TEL
092-553-9458
Homepage URL
miyazaki.hitomi.309@m.kyushu-u.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Other
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
DaiwaA Hamamatsucho Building 6F, 1-9-10 Hamamatsucho, Minato-ku, Tokyo
Tel
03-5408-1590
shiba_palace@s-palace-clinic.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
| 2023 | Year | 10 | 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
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 | 10 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 29 | 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 | 10 | Month | 12 | Day |
Last modified on
| 2024 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059806
