UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the glycemic responce and satiety continuation effect of high amylose rice
Title of the study (Brief title)	Study of high amylose rice inhibitory effect on postprandial hyperglycemia
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the inhibitory effect of high amylose rice koshinokaori cooked with the normal and high water content on postprandial hyperglycemia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Blood glucose response (blood glucose level at each blood collection time, peak blood glucose value and AUC) (blood collection : 0, 15, 30, 45, 60, 90 and 120 min after the intake of rice)
Key secondary outcomes	Insulin response Subjective satiety (Visual Analogue Scale) Appetite related hormones (GLP-1)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Koshihikari cooked rice: normal water content (single ingestion/ rice portion containing 50 g available carbohydrate) (wash-out: more than 1 week) Koshinokaori cooked rice: high water content (single ingestion/ rice portion containing 50 g available carbohydrate) (wash-out: more than 1 week) Koshinokaori cooked rice: normal water content (single ingestion/ rice portion containing 50 g available carbohydrate)
Interventions/Control_2	Koshinokaori cooked rice: normal water content (single ingestion/ rice portion containing 50 g available carbohydrate) (wash-out: more than 1 week) Koshihikari cooked rice: normal water content (single ingestion/ rice portion containing 50 g available carbohydrate) (wash-out: more than 1 week) Koshinokaori cooked rice: high water content (single ingestion/ rice portion containing 50 g available carbohydrate)
Interventions/Control_3	Koshinokaori cooked rice: high water content (single ingestion/ rice portion containing 50 g available carbohydrate)(wash-out: more than 1 week) Koshinokaori cooked rice: normal water content (single ingestion/ rice portion containing 50 g available carbohydrate) (wash-out: more than 1 week) Koshihikari cooked rice: normal water content (single ingestion/ rice portion containing 50 g available carbohydrate)
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	40 years-old >
Gender	Male and Female
Key inclusion criteria	healthy volunteers BMI < 25 kg/m2 Those who signed the informed consent for participation in the study
Key exclusion criteria	1. Subjects who are taking the medicines or the healthy foods such as supplements that affect the glycemic response 2. Subjects who are pregnant or lactating 3. Subjects who are smoking habit 4. Subjects who are judged by a doctor to be unsuitable
Target sample size	20

Research contact person
Name of lead principal investigator	Yukio YAMORI
Organization	Mukogawa Women's University
Division name	Institute for World Health Development
Address	4-16 Edagawa-cho, Nishinomiya-City, Hyogo 663-8143, JAPAN
TEL	+81-798-45-9980
Email	project@mukogawa-u.ac.jp

Public contact
Name of contact person	Mari MORI
Organization	Mukogawa Women's University
Division name	Institute for World Health Development
Address	4-16 Edagawa-cho, Nishinomiya-City, Hyogo 663-8143, JAPAN
TEL	+81-798-45-9980
Homepage URL
Email	project@mukogawa-u.ac.jp

Sponsor
Institute	Mukogawa Women's University Institute for World Health Development
Institute
Department

Funding Source
Organization	Bourbon Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor	Osaka Kyoiku University
Name of secondary funｄer(s)

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	国立大学法人 大阪教育大学 Osaka Kyoiku University

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 31 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2015 Year 12 Month 04 Day
Anticipated trial start date	2016 Year 01 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 02 Month 17 Day
Last modified on	2018 Year 08 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024292