UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037429 |
|---|---|
| Receipt number | 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 18:46:57 |
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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
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
asako-t@unii.ac.jp
Sponsor or person
Institute
University of Niigata Prefecture
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042669
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| Registered date | File name |
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