UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035726 |
|---|---|
| Receipt number | R000040683 |
| Scientific Title | Regulation of the functions of the intestines by high resistant starch rice and changes in blood glucose level |
| Date of disclosure of the study information | 2019/02/01 |
| Last modified on | 2019/01/30 17:21:08 |
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Basic information
Public title
Regulation of the functions of the intestines by high resistant starch rice and changes in blood glucose level
Acronym
Regulation of the functions of the intestines by high resistant starch rice and changes in blood glucose level
Scientific Title
Regulation of the functions of the intestines by high resistant starch rice and changes in blood glucose level
Scientific Title:Acronym
Regulation of the functions of the intestines by high resistant starch rice and changes in blood glucose level
Region
| Japan |
Condition
Condition
Diabetes mellitus
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Regulation of the functions of the intestines by high resistant starch rice and changes in blood glucose level
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes of colon flora after a week after test initiation
changes in blood glucose level after test initiation
Key secondary outcomes
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
take a high resistant starch rice 200g for a week
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The subjects who are unable to provide individual consent
Key exclusion criteria
･Cerebrovascular disease,heart disease,kidney disease,digestive tract diseases,infection required notification
･Surgery history of the digestive tract
･Pregnant women
･The subjects who participate in other clinical study
･The subjects who are determined that the ineligible by doctor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | HISANORI TANIAI |
Organization
Yuri Kumiai General Hospital
Division name
Department of Diabetes
Zip code
Address
Yago38, Kawaguchi, Yurihonjo-shi, Akita, 015-0051, Japan
TEL
0184-27-1200
cocorozaci@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | HISANORI TANIAI |
Organization
Yuri Kumiai General Hospital
Division name
Department of Diabetes
Zip code
Address
Yago38, Kawaguchi, Yurihonjo-shi, Akita, 015-0051, Japan
TEL
0184-27-1200
Homepage URL
cocorozaci@gmail.com
Sponsor or person
Institute
Laboratory of Plant Physiology, Department of Biological Production, Faculty of Bioresource Sciences, Akita Prefectural University
Institute
Department
Personal name
Funding Source
Organization
National Agriculture and Food Research Organization
Organization
Division
Category of Funding Organization
Other
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
| 2019 | Year | 02 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2019 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 02 | Month | 04 | 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
| 2019 | Year | 01 | Month | 31 | Day |
Last modified on
| 2019 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040683
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
