UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033479 |
|---|---|
| Receipt number | R000037974 |
| Scientific Title | The cohort study on barley and intestinal environment |
| Date of disclosure of the study information | 2018/08/01 |
| Last modified on | 2024/01/30 16:04:19 |
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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 | Zentaro |
| Middle name | |
| Last name | Yamagata |
Organization
University of Yamanashi
Division name
Department of Health Sciences, School of Medicine (Public Health, Epidemiology, Human Genetics)
Zip code
409-3898
Address
1110, Shimokato, Chuo, Yamanashi, Japan
TEL
055-273-9564
zenymgt@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | Zentaro |
| Middle name | |
| Last name | Yamagata |
Organization
University of Yamanashi
Division name
Department of Health Sciences, School of Medicine (Public Health, Epidemiology, Human Genetics)
Zip code
409-3898
Address
1110, Shimokato, Chuo, Yamanashi, Japan
TEL
055-273-9564
Homepage URL
zenymgt@yamanashi.ac.jp
Sponsor or person
Institute
University of Yamanashi, Department of Health Sciences, School of Medicine (Public Health, Epidemiology, Human Genetics)
Institute
Department
Personal name
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
The ethics committee of the School of Medicine, University of Yamanashi
Address
1110 Shimokato, Chuo City, Yamanashi, Japan
Tel
055-273-9065
miwakoa@yamanashi.ac.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
| 2018 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
236
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 | 05 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
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
| 2024 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037974
