UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028923
Receipt number 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 11:27:58

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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 or person

Institute

Shiba Palace Clinic

Institute

Department

Personal name



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

Value
https://center6.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