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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037429
Receipt No. R000042669
Scientific Title Study on the cooking methods of high-amylose rice 'Koshi-no-kaori' for suppressed post-prandial blood glucose elevation
Date of disclosure of the study information 2019/08/01
Last modified on 2020/07/20

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Basic information
Public title Study on the cooking methods of high-amylose rice 'Koshi-no-kaori' for suppressed blood glucose elevation
Acronym Study on the cooking methods of high-amylose rice for suppressed blood glucose elevation
Scientific Title Study on the cooking methods of high-amylose rice 'Koshi-no-kaori' for suppressed post-prandial blood glucose elevation
Scientific Title:Acronym Study on the cooking methods of high-amylose rice for suppressed postprandial blood glucose elevation
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Rice with high amylose content tends to have inferior taste, due to low amylopectin content, but is also associated with lower post-prandial elevation in blood glucose level. This study aims to find a cooking method for rice with high amylose content that can result in improved taste while maintaining the inhibitory effects of postprandial elevation in blood glucose.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Blood glucose response
1.delta blood glucose level
2.peak blood glucose value
3.AUC

Key secondary outcomes Sensory evaluation of taste

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 <Test 1>
Eating 1.5 times water content of "Koshihikari" cooked rice (Total amount of carbohydrates is set at 50g)
<Test 2>
Eating 2.0 times water content of "Koshinokaori" cooked high amylose rice (Total amount of carbohydrates is set at 50g)
<Test 3>
Eating 1.8 times water content of "Koshinokaori" cooked by the pressure cooker high amylose rice (Total amount of carbohydrates is set at 50g)
<Test 4>
Eating 1.8 times water content of "Koshinokaori" cooked by the pressure cooker high amylose rice added 3% erythritol (Total amount of carbohydrates is set at 50g)

Each test is performed approximately 2 days apart and conduced at the same time in the morning.

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

Not applicable
Gender Male and Female
Key inclusion criteria Subjects who satisfy the following conditions
1)Who do not fit key exclusion criteria
2)Who provide written informed consents
Key exclusion criteria 1)Who has food allergy to the test meals
2)Who takes the medicines or the healthy foods such as supplements that affect the glycemic response
3)Who will get pregnant or breast-feed during the study period
4)Who join other human studies
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Asako
Middle name
Last name Tamura
Organization University of Niigata Prefecture
Division name Faculty of Human Life Studies, Department of Health and Nutrition
Zip code 950-8680
Address 471, Ebigase, Higashi-ku, Niigata-city, Niigata prefecture
TEL 025-270-0366
Email asako-t@unii.ac.jp

Public contact
Name of contact person
1st name Asako
Middle name
Last name Tamura
Organization University of Niigata Prefecture
Division name Faculty of Human Life Studies, Department of Health and Nutrition
Zip code 950-8680
Address 471, Ebigase, Higashi-ku, Niigata-city, Niigata prefecture
TEL 025-270-0366
Homepage URL
Email asako-t@unii.ac.jp

Sponsor
Institute University of Niigata Prefecture
Institute
Department

Funding Source
Organization University of Niigata Prefecture
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s)

IRB Contact (For public release)
Organization University of Niigata Prefecture
Address 471, Ebigase, Higashi-ku, Niigata-city, Niigata prefecture
Tel 0252700366
Email asako-t@unii.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 新潟県立大学(新潟県)
University of Niigata Prefecture (Niigata prefecture)

Other administrative information
Date of disclosure of the study information
2019 Year 08 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 10
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
2019 Year 07 Month 01 Day
Date of IRB
2019 Year 03 Month 26 Day
Anticipated trial start date
2019 Year 07 Month 22 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
2019 Year 07 Month 19 Day
Last modified on
2020 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042669

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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