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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028923
Receipt No. R000032657
Scientific Title Influence of intake of bean-containing food on intestinal environment
Date of disclosure of the study information 2017/08/31
Last modified on 2018/09/03

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Basic information
Public title Influence of intake of bean-containing food on intestinal environment
Acronym The effect of food on intestinal environment
Scientific Title Influence of intake of bean-containing food on intestinal environment
Scientific Title:Acronym The effect of food on intestinal environment
Region
Japan

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

Objectives
Narrative objectives1 In order to verify the change of the intestinal microflora by ingestion of breakfast containing a lot of dietary fiber, first as a pilot study, we conduct a single group open-label study to verify the health effects of intervention at the individual level.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Enterobacterial bacteria examination on pre and post of the study.
Key secondary outcomes Bowel survey (bowel movement and feculent)
Diary web questionnaire

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 Curry Soup,Onion Soup and Ginger Soup were consumed at breakfast for 10 days each.
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
30 years-old <=
Age-upper limit
49 years-old >=
Gender Male
Key inclusion criteria 1) Persons who have bowel movements every day
2) Persons who are taking breakfast everyday
3) Persons who can replace retort food about 160g(energy amount 159 to 196 kcal) with normal breakfast, or can add one
4) Persons with constant lifestyle
Key exclusion criteria 1) Persons with constipation tendency
2) Persons with diarrheal tendency
3) Persons who have had antibiotic medication history within the past month
4) Persons who have history of hospitalization or surgery within the past 10 years
5) Persons who are taking medications (antibiotics, drugs with intestinal action, etc.) that are likely to affect the test results
6) Persons routinely taking health foods (supplements that promote intestinal action, etc.) that are likely to affect the test results
7) Alcohol addiction
8) Persons who have food allergies
9) Participating in other clinical trials
10) Persons who have a history of serious liver disorder, kidney disorder, heart disease
11) Persons who have a history of hepatitis or who are currently suffering from hepatitis
12) Persons with serious anemia
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Koikeda
Organization Shiba Palace Clinic
Division name Chair
Zip code
Address 6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL 03-5408-1590
Email jimukyoku@mail.souken-r.com

Public contact
Name of contact person
1st name
Middle name
Last name Ko MASUDA
Organization SOUKEN Co., Ltd
Division name Management Division
Zip code
Address 3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105
TEL 03-5408-1555
Homepage URL
Email k_masuda@mail.souken-r.com

Sponsor
Institute Shiba Palace Clinic
Institute
Department

Funding Source
Organization ROHTO Pharmaceutical 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
Address
Tel
Email

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
2017 Year 08 Month 31 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
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
2017 Year 07 Month 06 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 31 Day
Last modified on
2018 Year 09 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032657

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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