UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047924 |
|---|---|
| Receipt number | R000054634 |
| Scientific Title | Study of distribution of aging markers in various biological samples. |
| Date of disclosure of the study information | 2022/06/03 |
| Last modified on | 2023/06/02 14:10:45 |
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Basic information
Public title
Study of distribution of aging markers in various biological samples.
Acronym
Study of distribution of aging markers.
Scientific Title
Study of distribution of aging markers in various biological samples.
Scientific Title:Acronym
Study of distribution of aging markers.
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the distribution of aging markers concentration of in various biological samples and their relationship with lifestyle habits, etc.
Basic objectives2
Others
Basic objectives -Others
Investigate the distribution of aging markers and their relationship with lifestyle habits.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
mtDNA concentration (/ genomic DNA, oral swab sample)
Key secondary outcomes
Blood e-NAMPT, BDNF, GH?IGF-1, IL-6, FGF-21, SPARC, Irisin, adiponectin, myostatin (GDF-8) concentration (filter paper blood sample)
Intestinal microbiome (stool sample)
Oral microbiome (saliva sample)
Questionnaire on someone's lifestyle
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.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2.Japanese over 20 years old at the time of consent
Key exclusion criteria
1.Persons who take antithrombotic drugs (aspirin, clopidogrel, warfarin, edoxaban, etc.)
2.Persons who were judged as inappropriate for subjects by the principal investigator
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Takamasa |
| Middle name | |
| Last name | Masuda |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
masudat@hc-sys.jp
Public contact
Name of contact person
| 1st name | Takamasa |
| Middle name | |
| Last name | Masuda |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
Homepage URL
masudat@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
MIRAILAB BIOSCIENCE Inc.
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
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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
| 2022 | Year | 06 | 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
1105
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 | 05 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study on the distribution of aging markers and their relationship with lifestyle habits, etc.
Management information
Registered date
| 2022 | Year | 06 | Month | 02 | Day |
Last modified on
| 2023 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054634
