UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the effects of aseptic-packaged low-protain cooked rice helping to responce moderately to postprandial blood glucose level on postprandial blood glucose and insulin levels in subjects with borderline type 2 diabetes melitus
Title of the study (Brief title)	Evaluation of the effects of packed low-protain boiled rice helping to response moderately to postprandial blood glucose level on postprandial blood glucose and insulin levels
Region	Japan

Condition
Condition	Healthy adults with impaired fasting glucose (fasting plasma glucose, 110-125 mg/dl) or with impaired glucose tolerance (120 minutes glucose level in 75g-OGTT, 140 - 199 mg/dl))
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Measurement of time-dependent changes in blood glucose, insuln, and incretin levels after intake of aseptic-packaged low-protain cooked rice
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Time-dependent changes in postprandial plasma glucose levels
Key secondary outcomes	Time-dependent changes in postprandial insulin and incretin levels

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Test food: aseptic-packaged low-protain cooked rice, 140g
Interventions/Control_2	Control food: aseptic-packaged Niigata Koshihikari cooked rice, 148g
Interventions/Control_3
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	30 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1.Fasting plasma glucose levels are from 110 to 126 mg/dl or 2 minutes glucose levels in 75g-oral glucose tolerance test (OGTT) are from 140 to 200 mg/dl. 2.Volunteers being able to make self-judgent to particupate in this study and giving written informed consent. 3.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.Diabetes mellitus. 4.Subjects who use oral medication affecting blood glucose. 5.Volunteers rejected participating in this study by chief investigater.
Target sample size	10

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, 956-0841, Japan
TEL	0250-25-1196
Homepage URL
Email	nbrp-food-navi@nbrp.co.jp

Sponsor
Institute	Niigata Bio-Research Park, Inc
Institute
Department

Funding Source
Organization	Foricafoods Corporation.
Organization
Division
Category of Funding Organization	Profit organization
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	2016 Year 03 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 22 Day
Anticipated trial start date	2016 Year 03 Month 07 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	2016 Year 03 Month 07 Day
Last modified on	2016 Year 12 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024648