UMIN-CTR Clinical Trial

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

Contact us.