UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025642
Receipt number R000029415
Scientific Title Functional study of sterile packaged cooked rice containing Koshihikari brown rice and black brown rice.
Date of disclosure of the study information 2017/01/24
Last modified on 2017/03/23 14:58:17

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Basic information

Public title

Functional study of sterile packaged cooked rice containing Koshihikari brown rice and black brown rice.

Acronym

Functional study of sterile packaged cooked rice containing Koshihikari brown rice and black brown rice.

Scientific Title

Functional study of sterile packaged cooked rice containing Koshihikari brown rice and black brown rice.

Scientific Title:Acronym

Functional study of sterile packaged cooked rice containing Koshihikari brown rice and black brown rice.

Region

Japan


Condition

Condition

Healty volunteers

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Comparative evaluation of the time dependent changes of the postprandial blood glucose , insulin, incretin levels, and amyloid-beta as an indicator of cognitive impairment after ingestion of three types of sterile packaged cooked rice.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Time-dependent changes in postprandiial blood glucose and insulin levels.

Key secondary outcomes

Changes in incretin and amyloid-beta levels.


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Control meal : Koshihikari white rice (150g) with water (200mL) > Washout period 1 week > Test meal-1 : Koshihikari brown rice and black brown rice (151.5g) with water (200mL) > Washout period 1 week > Test meal-2 : Heat-moisture treated rice (151.5g) with water (200mL)

Interventions/Control_2

Test meal-1 : Koshihikari brown rice and black brown rice (151.5g) with water (200mL) > Washout period 1 week > Test meal-2 : Heat-moisture treated rice (151.5g) with water (200mL) > Washout period 1 week > Control meal : Koshihikari white rice (150g) with water (200mL)

Interventions/Control_3

Test meal-2 : Heat-moisture treated rice (151.5g) with water (200mL) > Washout period week > Control meal : Koshihikari white rice (150g) with water (200mL) > Washout period 1 week > Test meal-1 : Koshihikari brown rice and black brown rice (151.5g) with water (200mL)

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

50 years-old >

Gender

Male and Female

Key inclusion criteria

1.Body mass index (BMI) = <30.
2.Fasting plasma glucose 70-110mg/dl
3.Volunteers being able to make self-judgent to particupate in this study and giving written informed consent.
4.Volunteers having screening test results judged to be appropriate for this study by investigator.

Key exclusion criteria

1.Volunteers having severe history of the diseases (liver,kidney,hert,blood) judged to be inappropriate for this study.
2.Volunteers received gastrectomy,enterectomy,and gastro-intestinal dedeases,judged to be inappropriate for this study.
3.Volunteers having diabetes .
4.Volunteers rejected participating in this study by chief investigater.

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenichi Watanabe

Organization

Niigata Universty of Pharmacy and Applied Life Sciences

Division name

Laboratory of Clinical pharmacology

Zip code


Address

265-1, Higashijima, Akiha-ku, Niigata City

TEL

0250-25-5267

Email

watanabe@nupals.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Niigata Bio-Research Park, Inc

Organization

Niigata Bio-Research Park, Inc

Division name

Business promotion division

Zip code


Address

316-2 Higashijima, Akiha-ku, Niigata, 956-0811, Japan

TEL

0250-25-1196

Homepage URL


Email

goto@nbrp.co.jp


Sponsor or person

Institute

Niigata Bio-Research Park , Inc

Institute

Department

Personal name



Funding Source

Organization

Niigata University of Phamacy and Applied Life Sciences , Faculty of Applied Life Sciences.

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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



Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 24 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


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

2016 Year 12 Month 13 Day

Date of IRB


Anticipated trial start date

2017 Year 01 Month 25 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 01 Month 12 Day

Last modified on

2017 Year 03 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029415


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name