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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033479
Receipt No. R000037974
Scientific Title The cohort study on barley and intestinal environment
Date of disclosure of the study information 2018/08/01
Last modified on 2018/07/13

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Basic information
Public title The cohort study on barley and intestinal environment
Acronym The cohort study on barley and intestinal environment
Scientific Title The cohort study on barley and intestinal environment
Scientific Title:Acronym The cohort study on barley and intestinal environment
Region
Japan

Condition
Condition Adult
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify correlations between barley intake, lifestyle habits, residential environment and gut microbiome or correlations between barley intake, lifestyle habits, residential environment, gut microbiome and disease onset.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes alfa-diversity(Shannon index, Chao1, Phylogenetic diversity)
Key secondary outcomes Onset risk of allergic diseases
Onset risk of cold syndromes
Onset risk of influenza
Onset risk of lifestyle-related diseases (diabetes, hypertension, hyperlipidemia, metabolic syndrome, hyperuricemia and obesity)

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) The employees of Hakubaku Co.,Ltd.
(2) Basically, employees of 20 years of age or older
exc. employees who are under 20 years old but have enough judgement ability to join the study
Key exclusion criteria No
Target sample size 360

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Zentaro Yamagata
Organization University of Yamanashi
Division name Department of Health Sciences, School of Medicine (Public Health, Epidemiology, Human Genetics)
Zip code
Address 1110, Shimokato, Chuo, Yamanashi, Japan
TEL 055-273-9564
Email zenymgt@yamanashi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Zentaro Yamagata
Organization University of Yamanashi
Division name Department of Health Sciences, School of Medicine (Public Health, Epidemiology, Human Genetics)
Zip code
Address 1110, Shimokato, Chuo, Yamanashi, Japan
TEL 055-273-9564
Homepage URL
Email zenymgt@yamanashi.ac.jp

Sponsor
Institute University of Yamanashi, Department of Health Sciences, School of Medicine (Public Health, Epidemiology, Human Genetics)
Institute
Department

Funding Source
Organization No
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Laboratory of Vaccine Materials, National Institutes of Biomedical Innovation, Health and Nutrition
Hakubaku Co.,Ltd.
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

Other administrative information
Date of disclosure of the study information
2018 Year 08 Month 01 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 Open public recruiting
Date of protocol fixation
2018 Year 05 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cross-sectional and longitudinal studies about barley intake, intestinal environment, brief-type self-administered diet history questionnaire(BDHQ) and lifestyle habits

Management information
Registered date
2018 Year 07 Month 23 Day
Last modified on
2018 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037974

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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