UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022045 |
|---|---|
| Receipt number | R000025348 |
| Scientific Title | Effect of staple food on the intestinal environment of healthy adults |
| Date of disclosure of the study information | 2016/04/25 |
| Last modified on | 2016/06/28 11:59:10 |
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Basic information
Public title
Effect of staple food on the intestinal environment of healthy adults
Acronym
Effect of staple food on the intestinal environment of healthy adults
Scientific Title
Effect of staple food on the intestinal environment of healthy adults
Scientific Title:Acronym
Effect of staple food on the intestinal environment of healthy adults
Region
| Japan |
Condition
Condition
Healthy people
Classification by specialty
| Medicine in general | Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of staple food (rice or bread) on the intestinal flora
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
levels of bifidobacterium
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
No common drugs, No abnormality in the health diagnosis in one years
Key exclusion criteria
No agreement, chronic disease, common drugs, rice allergy, wheat allergy, Taking intestinal drugs and antibiotics during the study period, if there was diarrhea, fever, obvious poor health during the study period, If the short-chain fatty acid content was abnormally high.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaori Ikeda |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Diabetes, Endocrinology and Nutrition
Zip code
Address
54, Kawaramachi, Shougoin, Sakyo-ku, Kyoto city, Kyoto, Japan
TEL
0757513560
krikeda@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kaori Ikeda |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Diabetes, Endocrinology and Nutrition
Zip code
Address
54, Kawaramachi, Shougoin, Sakyo-ku, Kyoto city, Kyoto, Japan
TEL
0757513560
Homepage URL
krikeda@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Ministry of Agriculture, Forestry and Fisheries
Institute
Department
Personal name
Funding Source
Organization
Interdisciplinary fusion joint research, Ministry of Agriculture, Forestry and Fisheries
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2016 | Year | 04 | Month | 25 | 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
| 2016 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | 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
nothing special
Management information
Registered date
| 2016 | Year | 04 | Month | 25 | Day |
Last modified on
| 2016 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025348
