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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043680
Receipt No. R000049875
Scientific Title Effect of arabinoxylan intake on gut microbiota and intestinal environment
Date of disclosure of the study information 2021/03/20
Last modified on 2021/03/19

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Basic information
Public title Effect of arabinoxylan intake on gut microbiota and intestinal environment
Acronym Effect of arabinoxylan intake on gut microbiota and intestinal environment
Scientific Title Effect of arabinoxylan intake on gut microbiota and intestinal environment
Scientific Title:Acronym Effect of arabinoxylan intake on gut microbiota and intestinal environment
Region
Japan

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

Objectives
Narrative objectives1 To investigate the effects of intervention of arabinoxylan-rich diet on gut microbiota and intestinal environment.
Basic objectives2 Others
Basic objectives -Others To evaluate the effect of arabinoxylan-rich diet on gut microbiota and intestinal environment.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Gut microbiota composition
Key secondary outcomes Stool properties.

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 One week intervention of commercially available cereal diet (Twice 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subjects having an ability to understand study purpose and detail with voluntary written informed consent.
Key exclusion criteria Wheat allergy
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Takahiro
Middle name
Last name Matsuki
Organization Yakult Central Institute
Division name Basic Research department
Zip code 186-8650
Address 5-11 Izumi, Kunitachi, Tokyo, Japan
TEL 042-577-8960
Email takahiro-matsuki@yakult.co.jp

Public contact
Name of contact person
1st name Yohei
Middle name
Last name Watanabe
Organization Yakult Central Institute
Division name Basic Research department
Zip code 186-8650
Address 5-11 Izumi, Kunitachi, Tokyo, Japan
TEL 042-577-8960
Homepage URL
Email yohei-watanabe@yakult.co.jp

Sponsor
Institute Basic Research department, Yakult Central Institute
Institute
Department

Funding Source
Organization Basic Research department, Yakult Central Institute
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 Ethical committee of Yakult Central Institute
Address 5-11 Izumi, Kunitachi, Tokyo, Japan
Tel 042-577-8960
Email takahiro-matsuki@yakult.co.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 03 Month 20 Day

Related information
URL releasing protocol Manuscript in preparation
Publication of results Unpublished

Result
URL related to results and publications Manuscript in preparation
Number of participants that the trial has enrolled 27
Results manuscript in preparation
Results date posted
2021 Year 03 Month 19 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics manuscript in preparation
Participant flow manuscript in preparation
Adverse events manuscript in preparation
Outcome measures manuscript in preparation
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 05 Month 09 Day
Date of IRB
2018 Year 06 Month 14 Day
Anticipated trial start date
2018 Year 09 Month 25 Day
Last follow-up date
2018 Year 11 Month 13 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 03 Month 19 Day
Last modified on
2021 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049875

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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