UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053945 |
|---|---|
| Receipt number | R000061570 |
| Scientific Title | Blood kinetics study of a single intake of the test food. |
| Date of disclosure of the study information | 2024/03/25 |
| Last modified on | 2025/04/11 10:47:45 |
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Basic information
Public title
Blood kinetics study of a single intake of the test food.
Acronym
Blood kinetics study of a single intake of the test food.
Scientific Title
Blood kinetics study of a single intake of the test food.
Scientific Title:Acronym
Blood kinetics study of a single intake of the test food.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the blood kinetics of active ingredients during a single intake of the test food.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood kinetics (Cmax)
Key secondary outcomes
Blood kinetics (Tmax)
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 test food.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Employees of Hayashibara who have been with the company for at least one year and are in good health and are between the ages of 18 and 65
2) Those who are not pregnant or breastfeeding.
3) Subjects who can participate in dietary interventions, intake of the test foods, blood samplings, and maintain rest as scheduled.
4) Subjects who voluntarily give written informed consent.
Key exclusion criteria
1)Pregnant or lactating persons.
2)Subjects with a liver function gammma-GTP level of 50 IU/L or higher.
3)Subjects judged as unsuitable for the study by the responsible doctor for other reasons.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Mika |
| Middle name | |
| Last name | Yamada |
Organization
Hayashibara CO., LTD.
Division name
Product Development Section Development Unit Food System Solutions Division
Zip code
7028006
Address
675-1, Fujisaki, naka-ku, Okayama, Okayama, JAPAN
TEL
0862763141
mika.yamada@hb.nagase.co.jp
Public contact
Name of contact person
| 1st name | Mika |
| Middle name | |
| Last name | Yamada |
Organization
Hayashibara CO., LTD.
Division name
Product Development Section Development Unit Food System Solutions Division
Zip code
7028006
Address
675-1, Fujisaki, naka-ku, Okayama, Okayama, JAPAN
TEL
0862763141
Homepage URL
mika.yamada@hb.nagase.co.jp
Sponsor or person
Institute
Hayashibara CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Hayashibara Co., Ltd.
Address
675-1, Fujisaki, Naka-ku, Okayama
Tel
0862763141
HB96301@hb.nagase.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
| 2024 | Year | 03 | Month | 25 | 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 | 11 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 22 | Day |
Last modified on
| 2025 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061570
