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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Healthy adults | ||
Classification by specialty |
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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 |
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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. |
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Interventions/Control_2 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 10 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
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Date analysis concluded |
Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |