UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence of intake of bean-containing food on intestinal environment
Title of the study (Brief title)	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	Takashi Koikeda
Organization	Shiba Palace Clinic
Division name	Chair
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	Ko MASUDA
Organization	SOUKEN Co., Ltd
Division name	Management Division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000032657