UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Measurement of glycemic index (GI) of rice flour noodles
Title of the study (Brief title)	Measurement of glycemic index (GI) of rice flour noodles
Region	Japan

Condition
Condition	No(subjects with fasting plasma glucose < 110mg/dl and HbA1c < 5.9%)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Measurement of glycemic indexs(GI) of rice flour noodles of three varieties
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Glycemic index(GI)
Key secondary outcomes

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	4
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	placebo food
Interventions/Control_2	Rice flour noodle food-1
Interventions/Control_3	Rice flour noodle food-2
Interventions/Control_4	Rice flour noodle food-3
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.Volunteers with no glucose intolelance in the past year. 3.Fasting plasma glucose 70-110mg/dl 4.Volunteers being able to make self-judgment to participate in this study and giving written informed consent. 5.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, heart, 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 risk of diabetes mellitus (fasting plasma glucose > = 110mg/dl and HbA1c > = 5.9%). 4.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 University of Pharmacy and Applied Life Sciences
Division name	Laboratory fo 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	goto@nbrp.co.jp

Sponsor
Institute	Niigata Bio-Research Park, Inc
Institute
Department

Funding Source
Organization	NATIONAL AGRICULTURE AND FOOD RESERCH ORGANIZAION NARO/AGRICULTURAL AND RECERCH CENTER HOKURIKU RESEARCH CENTER
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	2015 Year 01 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 24 Day
Anticipated trial start date	2015 Year 01 Month 05 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 01 Month 23 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=R000018810