UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050226 |
|---|---|
| Receipt number | R000057200 |
| Scientific Title | Exploration of biomarkers to visualize Nrf2 activity |
| Date of disclosure of the study information | 2023/02/03 |
| Last modified on | 2024/08/14 10:24:53 |
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Basic information
Public title
Search for new health indicators to capture signs of health status change
Acronym
Developing new indicators to predict health status
Scientific Title
Exploration of biomarkers to visualize Nrf2 activity
Scientific Title:Acronym
Search for Nrf2 markers
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between Nrf2 activity and biological factors
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analyze changes in biological factors (metabolome, proteome etc.) following ingestion of NRF2-activated materials.
(Sample and data were obtained from jRCTs021210018)
Key secondary outcomes
Base
Study type
Observational
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
| 20 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy adults.
2. Those who agree to informed consent.
Key exclusion criteria
Subjects who are judged unsuitable for this trial by the principal investigator
Target sample size
29
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Itoh |
Organization
Hirosaki University
Division name
Department of Stress Response Science, Graduate School of Medicine
Zip code
0368562
Address
5-Zaifu-cho Hirosaki, Aomori 036-8562, Japan
TEL
0172-39-5157
Itohk@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Itoh |
Organization
Hirosaki university
Division name
Department of Stress Response Science, Graduate School of Medicine
Zip code
036-8562
Address
5-Zaifu-cho Hirosaki, Aomori 036-8562, Japan
TEL
0172-39-5157
Homepage URL
Itohk@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki University
Institute
Department
Personal name
Funding Source
Organization
KAGOME Co., Ltd.
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
Ethics Committee of Hirosaki University Graduate School of Medicine
Address
5-Zaifu-cho Hirosaki, Aomori 036-8562, Japan
Tel
0172-39-5044
rinri@hirosaki-u.ac.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 | 02 | Month | 03 | 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
29
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
| 2022 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data and samples obtained at Specified Clinical Research (jRCTs021210018), will be analysed to search the Nrf2 markers.
Management information
Registered date
| 2023 | Year | 02 | Month | 03 | Day |
Last modified on
| 2024 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057200
