UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053605 |
|---|---|
| Receipt number | R000061143 |
| Scientific Title | A study to evaluate safety and mechanisms through food intake using existing specimens. |
| Date of disclosure of the study information | 2024/04/15 |
| Last modified on | 2024/02/13 12:17:05 |
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Basic information
Public title
A study to evaluate safety and mechanisms through food intake using existing specimens.
Acronym
A study to evaluate safety and mechanisms through food intake using existing specimens.
Scientific Title
A study to evaluate safety and mechanisms through food intake using existing specimens.
Scientific Title:Acronym
A study to evaluate safety and mechanisms through food intake using existing specimens.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A study to evaluate safety and mechanisms through food intake using existing specimens.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood level of TMAO
related metabolites (betaine, L-alpha-Glycerylphosphorylcholine, folic acid)
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 60 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects examined in the other study (UMIN000041554)
Key exclusion criteria
Subjects whose specimen have not been obtained in the study (UMIN000041554).
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Takeda |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
1820002
Address
2-5-7, Sengawa-cho, Chofu-shi, Tokyo
TEL
03-5384-7759
yumi_takeda@kewpie.co.jp
Public contact
Name of contact person
| 1st name | Yui/ Wei |
| Middle name | |
| Last name | Ou/Wang |
Organization
Kewpie Corporation
Division name
R&D Division
Zip code
1820002
Address
2-5-7, Sengawa-cho, Chofu-shi, Tokyo
TEL
03-5384-7759
Homepage URL
yui_ou@kewpie.co.jp
Sponsor or person
Institute
Kewpie Corporation
Institute
Department
Personal name
Funding Source
Organization
Kewpie 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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17, Jotomachi, Maebashi Shi, Gumma Ken, 371-0016, Japan
Tel
027-212-5608
sagawa@mc-connect.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
株式会社LSIメディエンス LSI Medience
広島大学 Hiroshima University
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 15 | 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
| 2024 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is conducted using samples obtained in the other study (UMIN000041554). There is no intervention and invasion in this study.
Management information
Registered date
| 2024 | Year | 02 | Month | 13 | Day |
Last modified on
| 2024 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061143
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
