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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032744
Receipt No. 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 2018/05/28

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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
Middle name
Last name Yukako Hayashi
Organization Kyoto University
Division name Graduate School of Agriculture
Zip code
Address Gokasho, Uji, Kyoto
TEL 0774-38-3750
Email yhaayshi@kais.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukako Hayashi
Organization Kyoto University
Division name Graduate School of Agriculture
Zip code
Address Gokasho, Uji, Kyoto
TEL 0774-38-3750
Homepage URL
Email yhaayshi@kais.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

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
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
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 Open public recruiting
Date of protocol fixation
2017 Year 05 Month 26 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 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
2018 Year 05 Month 28 Day
Last modified on
2018 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036893

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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