UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An examination of the blood-glucose lowering effect of processed rice foods high in resistant starch
Title of the study (Brief title)	An examination of the blood-glucose lowering effect of processed rice foods high in resistant starch
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the blood-glucose lowering effect of processed rice foods high in resistant starch by measuring the changes in postprandial blood glucose and insulin levels.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Areas under the curves of postprandial blood glucose and insulin
Key secondary outcomes	Postprandial blood glucose and insulin levels

Base
Study type	Interventional

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

Intervention
No. of arms	4
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	test food-1 Rice crackers high in resistant starch / single dose administration / dose 30g/12min
Interventions/Control_2	placebo food-1 Nipponbare rice crackers / single dose administration / dose 27g/12min
Interventions/Control_3	test food-2 Boiled rice high in resistant starch / single dose administration / dose 175g/12min
Interventions/Control_4	placebo food-2 Nipponbare boiled rice / single dose administration / dose 160g/12min
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 levels are ranged from 70 to 126mg/dl 3.Volunteers being able to make self-judgent to participate 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 (e.g. liver, kidney, heart, and blood diseases) judged to be inappropriate for this study. 2.Diabetes. Fasting glucose levels, 126mg/dl=<. Hemoglobin A1c, 6.5%=<. 3.Volunteers received gastrectomy, enterectomy, and gastro-intestinal dedeases, judged to be inappropriate for this study. 4.Volunteers having food allergy related to rice and other grains. 5.Volunteers taking medicine which may influence glucose metabolism. 6.Volunteers who are planned to become pregnant after informed consent for the current study or are pregnant or lactating. 7.Volunteers rejected participating in this study by chief investigater.
Target sample size	20

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	KAMEDA SEIKA CO., LTD.
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	2015 Year 09 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 24 Day
Anticipated trial start date	2015 Year 09 Month 28 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	2015 Year 09 Month 25 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=R000022104