UMIN-CTR Clinical Trial

Public title

Study of the cooking methods for high-amylose rice 'Koshinokaori' for improved taste

Acronym

Study of the cooking methods for high-amylose rice 'Koshinokaori' for improved taste

Scientific Title

Study of the cooking methods for high-amylose rice 'Koshinokaori' for improved taste

Scientific Title:Acronym

Study of the cooking methods for high-amylose rice 'Koshinokaori' for improved taste

Region

Japan

Condition

Healthy adults

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Rice with high amylose content tends to
have inferior taste, due to low amylopectin content, but is also associated with lower postprandial 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

Primary outcomes

Blood glucose response
1.delta blood glucose level
2.peak blood glucose value
3.AUC
Sensory evaluation of taste

Key secondary outcomes

Study type

Interventional

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

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Test 1
Eating normal water content of Koshihikari cooked rice (Total amount of carbohydrates is set at 50g)
Test 2
Eating high water content of Koshinokaori cooked high amylose rice (Total amount of carbohydrates is set at 50g)
Test 3
Eating high water content of Koshinokaori cooked high amylose rice added 5% trehalose (Total amount of carbohydrates is set at 50g)
Test 4
Eating high water content of Koshinokaori cooked high amylose rice added 0.8% agar (Total amount of carbohydrates is set at 50g)
Test 5
Eating high water content of Koshinokaori cooked high amylose rice added 5% trehalose and 0.8% agar (Total amount of carbohydrates is set at 50g)

Each test is performed approximately one week 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

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

Name of lead principal investigator

1st name
Middle name
Last name	Asako TAMURA

Organization

University of Niigata prefecture

Division name

Faculty of Human Life Studies, Department of Health and Nutrition

Zip code

Address

471, Ebigase, Higashi-ku, Niigata-city, Niigata prefecture

TEL

025-270-0366

Email

asako-t@unii.ac.jp

Name of contact person

1st name
Middle name
Last name	Asako TAMURA

Organization

University of Niigata prefecture

Division name

Faculty of Human Life Studies,Department of Health and Nutrition

Zip code

Address

471, Ebigase,Higashi-ku, Niigata-city, Niigata prefecture

TEL

025-270-0366

Homepage URL

Email

asako-t@unii.ac.jp

Institute

University of Niigata prefecture

Institute

Department

Personal name

Organization

University of Niigata prefecture

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

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

新潟県立大学（新潟県）/ University of Niigata prefecture (Niigata prefecture)

Date of disclosure of the study information

2017

Year

08

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Completed

Date of protocol fixation

2017

Year

05

Month

30

Day

Date of IRB

Anticipated trial start date

2017

Year

07

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

06

Month

01

Day

Last modified on

2018

Year

12

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031629