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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035154
Receipt No. 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 2019/01/15

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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
Last name of lead principal investigator
1st name
Middle name
Last name Joe Inoue
Organization Humanome Lab, Inc.
Division name Head office
Zip code
Address 5-22-201 Suehiro, Tsuruoka, Yamagata, Japan
TEL +81-50-5436-4563
Email info@humanome.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Joe Inoue
Organization Humanome Lab, Inc.
Division name Head office
Zip code
Address 5-22-201 Suehiro, Tsuruoka, Yamagata, Japan
TEL +81-50-5436-4563
Homepage URL
Email info@humanome.jp

Sponsor
Institute Humanome Lab, Inc.
Institute
Department

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
Address
Tel
Email

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 No longer recruiting
Date of protocol fixation
2018 Year 11 Month 26 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 06 Day
Last follow-up date
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 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040031

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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