UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035154 |
|---|---|
| Receipt number | R000040031 |
| Scientific Title | Correlation analysis of comprehensive biological data obtained in daily life |
| Date of disclosure of the study information | 2018/12/06 |
| Last modified on | 2019/12/13 11:54:53 |
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Basic information
Public title
Correlation analysis of comprehensive biological data obtained in daily life
Acronym
Correlation analysis of comprehensive biological data obtained in daily life
Scientific Title
Correlation analysis of comprehensive biological data obtained in daily life
Scientific Title:Acronym
Correlation analysis of comprehensive biological data obtained in daily life
Region
| Japan |
Condition
Condition
Men and woman
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the correlation coefficient of comprehensive biological data obtained from individuals at same time period to identify their relationships
Basic objectives2
Others
Basic objectives -Others
Research
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of correlation based on correlation coefficients of factors in comprehensive biological data obtained from individuals at same time period
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
| 40 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Males and females who belong to Yunohama Hotspring Hotel Association or who live in the neighborhood of Yunohama, aged 40 to 69 years old.
(2) Subjects who show understanding of the study procedures and agreement with participating the study.
Key exclusion criteria
(1) Subjects who currently require hospital stay, or who have current medical history of severe disease, such as specific disease or disease require dialysis for its treatment.
(2) Subjects who have current medical history of sleeping disorder and/or mental disorder.
(3) Subjects with suspected infection.
(4) Subjects who possibly participate to other clinical trial.
(5) Subjects who have been determined ineligible by principal investigator.
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Joe |
| Middle name | |
| Last name | Inoue |
Organization
Humanome Lab, Inc.
Division name
Head office
Zip code
997-0015
Address
5-22-201 Suehiro, Tsuruoka, Yamagata, Japan
TEL
+81-50-5436-4563
info@humanome.jp
Public contact
Name of contact person
| 1st name | Joe |
| Middle name | |
| Last name | Inoue |
Organization
Humanome Lab, Inc.
Division name
Head office
Zip code
997-0015
Address
5-22-201 Suehiro, Tsuruoka, Yamagata, Japan
TEL
+81-50-5436-4563
Homepage URL
info@humanome.jp
Sponsor or person
Institute
Humanome Lab, Inc.
Institute
Department
Personal name
Funding Source
Organization
Ministry of Economy, Trade and Industry
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Metabologenomics, Inc.
NeuroSpace Co., Ltd.
Rhelixa, Inc.
Wellnas. Co., Ltd.
AMI Co., Ltd.
Yunohama Onsen Kameya
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Chushin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.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
山形湯野浜温泉 亀や
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | 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
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
| 2018 | Year | 11 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This research is aimed at people who work and live in Yunohama, the area where the aging has most progressed in Tsuruoka. Comprehensive biological data will be obtained and the correlation of those factors will be evaluated.
As comprehensive biological data, daily data (heart rate, blood pressure, etc), sleeping data, dietary data, gut microbiome data, heart sound, breathing sound and blood data will be obtained.
In this research, data will be obtained for two weeks during December, the busy period for the hotel workers, and during January, the off-season for the hotel workers.
Management information
Registered date
| 2018 | Year | 12 | Month | 06 | Day |
Last modified on
| 2019 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040031
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
