UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The of effects of newly developed long-chain amylopectin-containing-rice,Konayukinomai,and its processed products on postprandial glucose level.Long-team trial
Title of the study (Brief title)	Long-team trial on the developed long-chain amylopectin-containing-rice
Region	Japan

Condition
Condition	Metabolic Syndrome Initial Diabetes
Classification by specialty	Medicine in general Cardiology Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Long-term (3months) consumption of newly developed long-chain amylopectin-contain-rice,Konayukinomai,on glucose and insulin resistance was investigated in 60men
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood glucose level of the day Visceral fat area
Key secondary outcomes	HbA1c,insuline,food intake

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Konayukinomai as a steam rice per 200g once a day for 3 months
Interventions/Control_2	Kosihikari as a steam rice per 200g once a day for 3 months
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	70 years-old >
Gender	Male
Key inclusion criteria	Viceral fat area<100cm2 HbA1c<8.0%
Key exclusion criteria	Exsist hepatic failure or renal disease Food Allergy The person who was disqualified by a docotor
Target sample size	60

Research contact person
Name of lead principal investigator	Akira Tanaka
Organization	kagawa Nutrition University
Division name	Nutrition Clinic
Address	3-24-3 Komagome Toshima-ku, Tokyo
TEL	03-3918-6181
Email	atanaka@eiyo.ac.jp

Public contact
Name of contact person	Keiko Kamachi
Organization	Kagawa Nutrition University
Division name	Nutrition Clinic
Address	3-24-3 Komagome Tosimaku, Tokyo
TEL	03-3918-6181
Homepage URL
Email	kamachi@eiyo.ac.jp

Sponsor
Institute	Kagawa Nutriton University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	National Agriculture and Food Research Organization
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	2014 Year 09 Month 25 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2013 Year 11 Month 19 Day
Anticipated trial start date	2014 Year 04 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
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	2014 Year 09 Month 25 Day
Last modified on	2016 Year 06 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017727