UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Functional study of sterile packaged cooked rice containing Koshihikari brown rice and black brown rice.
Title of the study (Brief title)	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	Kenichi Watanabe
Organization	Niigata Universty of Pharmacy and Applied Life Sciences
Division name	Laboratory of Clinical pharmacology
Address	265-1, Higashijima, Akiha-ku, Niigata City
TEL	0250-25-5267
Email	watanabe@nupals.ac.jp

Public contact
Name of contact person	Niigata Bio-Research Park, Inc
Organization	Niigata Bio-Research Park, Inc
Division name	Business promotion division
Address	316-2 Higashijima, Akiha-ku, Niigata, 956-0811, Japan
TEL	0250-25-1196
Homepage URL
Email	goto@nbrp.co.jp

Sponsor
Institute	Niigata Bio-Research Park , Inc
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 12 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029415