UMIN-CTR Clinical Trial

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
Email	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
Email	h-otoshi@maruyanagi.co.jp

Sponsor
Institute	National Institutes of Biomedical Innovation, Health and Nutrition
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050136