UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055278 |
|---|---|
| Receipt number | R000063160 |
| Scientific Title | Measurement of various biomarkers in healthy subjects |
| Date of disclosure of the study information | 2024/09/06 |
| Last modified on | 2024/12/27 09:08:47 |
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Basic information
Public title
Measurement of various biomarkers in healthy subjects
Acronym
Measurement of various biomarkers in healthy subjects
Scientific Title
Measurement of various biomarkers in healthy subjects
Scientific Title:Acronym
Measurement of various biomarkers in healthy subjects
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Accumulate measurements of various biomarkers in healthy adults to improve the accuracy of reference value setting.
Basic objectives2
Others
Basic objectives -Others
To acquire data for the purpose of setting reference values.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Telomere Length
SIRT1mRNA
Alpha-Klotho(water-soluble)
8-OHdG(urine)
sIgA(Saliva)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Healthy Japanese men and women aged 20 years or older at the time of obtaining consent.
2) Subjects who have fully understood the content of the study and have given written consent of their own free will to participate in this study.
3) Subjects who have been deemed eligible by the principal investigator or sub-investigator based on a comprehensive assessment.
Key exclusion criteria
1) Subjects with severe liver impairment, renal or heart disease, diabetes, or other serious illnesses.
2) Subjects who are receiving medication treatment or are scheduled to receive medication during the study period.
3) Subjects who have participated in other clinical trials or studies within 84 days prior to the date of consent.
4) Subjects who have donated 400 mL of blood within 84 days, 200 mL of blood within 28 days, or have undergone apheresis (plasma or platelet donation) within 14 days prior to the date of consent.
5) Pregnant or breastfeeding women, and those who wish to become pregnant during the study period.
6) Subjects who are deemed inappropriate for participation in this study by the principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ayanori |
| Middle name | |
| Last name | Yamaki |
Organization
Yamada Bee Company, Inc.
Division name
Institute for Bee Products & Health Science, R&D department
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL
0868-54-3825
ay1255@yamada-bee.com
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Suwa |
Organization
Yamada Bee Company, Inc.
Division name
Institute for Bee Products & Health Science, R&D department
Zip code
708-0393
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
TEL
0868-54-3825
Homepage URL
ds2315@yamada-bee.com
Sponsor or person
Institute
Yamada Bee Company, Inc.
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Company, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Research Center for Immunological Analysis, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamada Bee Company Ethics Committee
Address
194 Ichiba, Kagamino-cho, Tomata-gun, Okayama 708-0393 Japan
Tel
0868-54-1199
irb@yamada-bee.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
| 2024 | Year | 09 | Month | 06 | 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
101
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
| 2024 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study
Management information
Registered date
| 2024 | Year | 08 | Month | 19 | Day |
Last modified on
| 2024 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063160
