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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035745
Receipt No. R000040715
Official scientific title of the study The investigation of the effect of sake lees intake on gut microbiota
Date of disclosure of the study information 2019/02/01
Last modified on 2019/02/01

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Basic information
Official scientific title of the study The investigation of the effect of sake lees intake on gut microbiota
Title of the study (Brief title) The investigation of the effect of sake lees intake on gut microbiota
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the effect of sake lees intake on gut microbiota.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of frequency of the good and bad bacteria from pre- to post: Week 0, 1, 2.
Key secondary outcomes The change of gut microbiota from pre- to post(Exploratory): Week 0, 1, 2.
Frequency of defecation and stool form: Week 0, 1, 2.

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 Treatment
Type of intervention
Food
Interventions/Control_1 Take 15g of sake lees a day for 2 weeks
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) Individuals aged more than 20 years.
2) Healthy individuals without any disease or treatment.
3) Individuals whose written informed consent has been obtained.
Key exclusion criteria 1) Individuals with alcohol intolerance or for whom alcohol intake is not acceptable.
2) Individuals who have received antibiotics within the past month.
Target sample size 20

Research contact person
Name of lead principal investigator Kazuaki Chayama
Organization Hiroshima University
Division name Department of Gastroenterology and Metabolism, Graduate School of Biomedical & Health Sciences
Address 1-2-3, Kasumi, Minami-ku, Hiroshima
TEL 082-257-5190
Email chayama@hiroshima-u.ac.jp

Public contact
Name of contact person Daiki Miki
Organization Hiroshima University
Division name Department of Gastroenterology and Metabolism, Graduate School of Biomedical & Health Sciences
Address 1-2-3, Kasumi, Minami-ku, Hiroshima
TEL 082-257-1500
Homepage URL
Email daikimiki@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University
Institute
Department

Funding Source
Organization Higashihiroshima City
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2019 Year 02 Month 01 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2019 Year 01 Month 29 Day
Anticipated trial start date
2019 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2019 Year 02 Month 01 Day
Last modified on
2019 Year 02 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040715

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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