UMIN-CTR Clinical Trial

Public title

Study of the glycemic responce and satiety continuation effect of high amylose rice

Acronym

Study of high amylose rice inhibitory effect on postprandial hyperglycemia

Scientific Title

Study of the glycemic responce and satiety continuation effect of high amylose rice

Scientific Title:Acronym

Study of high amylose rice inhibitory effect on postprandial hyperglycemia

Region

Japan

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Yukio YAMORI

Organization

Mukogawa Women's University

Division name

Institute for World Health Development

Zip code

Address

4-16 Edagawa-cho, Nishinomiya-City, Hyogo 663-8143, JAPAN

TEL

+81-798-45-9980

Email

project@mukogawa-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Mari MORI

Organization

Mukogawa Women's University

Division name

Institute for World Health Development

Zip code

Address

4-16 Edagawa-cho, Nishinomiya-City, Hyogo 663-8143, JAPAN

TEL

+81-798-45-9980

Homepage URL

Email

project@mukogawa-u.ac.jp

Institute

Mukogawa Women's University Institute for World Health Development

Institute

Department

Personal name

Organization

Bourbon Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

JAPAN

Co-sponsor

Osaka Kyoiku University

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国立大学法人 大阪教育大学 Osaka Kyoiku University

Date of disclosure of the study information

2016

Year

03

Month

31

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

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

Recruitment status

Main results already published

Date of protocol fixation

2015

Year

12

Month

04

Day

Date of IRB

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

Other related information

Registered date

2016

Year

02

Month

17

Day

Last modified on

2018

Year

08

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024292