UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044055 |
|---|---|
| Receipt number | R000050136 |
| Scientific Title | Effect of a test food on intestinal environment |
| Date of disclosure of the study information | 2021/07/30 |
| Last modified on | 2021/04/27 18:40:57 |
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Basic information
Public title
Effect of a test food on intestinal environment
Acronym
Effect of a test food on intestinal environment
Scientific Title
Effect of a test food on intestinal environment
Scientific Title:Acronym
Effect of a test food on intestinal environment
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of barley intake on intestinal environment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gut microbiome
Key secondary outcomes
Blood profile
Short Chain Fatty Acid
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Two months intervention of steamed barley 70 gram (Once per day)
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
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
Key exclusion criteria
1.Persons who are allergic to the grain such as barley and wheat
2.Persons who were judged as inappropriate for study participants by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Kunisawa |
Organization
National Institutes of Biomedical Innovation, Health and Nutrition
Division name
vaccine material project
Zip code
567-0085
Address
7-6-8 Saito Asagi Ibaraki City Osaka Prefecture
TEL
072-641-9871
kunisawa@nibiohn.go.jp
Public contact
Name of contact person
| 1st name | Hirofumi |
| Middle name | |
| Last name | Otoshi |
Organization
Maruyanagi. Co. Ltd.
Division name
Research and Development Department
Zip code
658-0044
Address
4-9-21 Mikagetukamachi Higashinada ward Kobe city
TEL
078-841-1456
Homepage URL
h-otoshi@maruyanagi.co.jp
Sponsor or person
Institute
National Institutes of Biomedical Innovation, Health and Nutrition
Institute
Department
Personal name
Funding Source
Organization
Maruyanagi. Co. Ltd.
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
Institutional Review Board of National Institutes of Biomedical Innovation, Health and Nutrition
Address
7-6-8 Saito Asagi Ibaraki City Osaka Prefecture
Tel
072-641-9829
irb-office@nibiohn.go.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
| 2021 | Year | 07 | Month | 30 | 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
60
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
| 2020 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 27 | Day |
Last modified on
| 2021 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050136
