UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032744 |
|---|---|
| Receipt number | R000036893 |
| Scientific Title | Evaluation of the effects of rice meal on the physiological action and post-meal blood glucose levels |
| Date of disclosure of the study information | 2018/05/28 |
| Last modified on | 2021/11/29 14:32:29 |
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Basic information
Public title
Evaluation of the effects of rice meal on the
physiological action and post-meal blood glucose levels
Acronym
Evaluation of the effects of rice meal on the
physiological action and post-meal blood glucose levels
Scientific Title
Evaluation of the effects of rice meal on the
physiological action and post-meal blood glucose levels
Scientific Title:Acronym
Evaluation of the effects of rice meal on the
physiological action and post-meal blood glucose levels
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measurement of time-dependent changes in blood glucose level after intake of rice meal.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose level after intake of rice meal
Key secondary outcomes
Area under the curve og blood glucose level after intake of rice meal
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Steamed Rice
Interventions/Control_2
Steamed Rice+Gyudon(without sauce)
Interventions/Control_3
Steamed Rice+Gyudon
Interventions/Control_4
Steamed Rice+Gyudon(without sauce)+salad
Interventions/Control_5
Steamed Rice+Gyudon+salad
Interventions/Control_6
Steamed Rice+Gyudon+cheese
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Subjects who can make self-judgement and are voluntarily giving written informed consent.
Key exclusion criteria
Persons who are allergic t the test meal
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yukako |
| Middle name | |
| Last name | Hayashi |
Organization
Kyoto University
Division name
Graduate School of Agriculture
Zip code
611-0011
Address
Gokasho, Uji, Kyoto
TEL
0774383750
hayashi.yukako.7s@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukako |
| Middle name | |
| Last name | Hayashi |
Organization
Kyoto University
Division name
Graduate School of Agriculture
Zip code
611-0011
Address
Gokasho, Uji, Kyoto
TEL
0774383750
Homepage URL
hayashi.yukako.7s@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
ZENSHO HOLDINGS Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Doshisha Women's College of Liberal Arts
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Universit
Address
Uji
Tel
0774-38-3750
hayashi.yukako.7s@kyoto-u.ac.jp
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
| 2018 | Year | 05 | Month | 28 | 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 | 05 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 28 | Day |
Last modified on
| 2021 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036893
