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
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
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
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
