UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Glycemic response study of beverages containing barley syrup with beta-glucan-randomaised, placebo-controled double blind design
Title of the study (Brief title)	Glycemic response study of beverages containing barley syrup with beta-glucan
Region	Japan

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

Objectives
Narrative objectives1	Measurement of glycemic response of beverages containing barley syrup with beta-glucan.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Postprandial blood glucose level Measurement of blood glucose level on a day when test foods were eaten. Incremental blood glucose area under the curve Postprandial blood glucose level after boiled rice were eaten Incremental blood glucose area under the curve after boiled rice were eaten
Key secondary outcomes	Postprandial blood glucose level, Postprandial maximum blood glucose level, and Insulin level Postprandial 120 minutes blood glucose level, and Insulin level Hemoglobin A1c

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved 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	Glucose solution as reference (75g/225ml) - wash out period (at least 1 week) - beverages containing barley syrup with beta glucan- wash out period (at least 1 week) - beverages containing barley syrup
Interventions/Control_2	Glucose solution as reference (75g/225ml) - wash out period (at least 1 week) - beverages containing barley syrup - wash out period (at least 1 week) - beverages containing barley syrup with beta glucan
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	18 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Subjects who don't has abnormal glucose tolerance and don't take diabetes drug. 2) Subjects who is between 18 and 65 years old. 3) Subjects who wrote informed consent. 4) Subjects who don't join other human studies within one month. 5) Subjects who are judged as suitable for the study by the invesigator. 6) Subjects whose plasma glucose blood level or OGTT glucose blood level is wihtin 2SD by a statistical analysis.
Key exclusion criteria	1) Subjects who has abnormal glucose tolerance or take diabetes drug. 2) Subjects who is under 18 or over 65 years old. 3) Subjects who don't write informed consent. 4) Subjects who join other human studies within one month. 5) Subjects who are judged as unsuitable for the study by the invesigator. 6) Subjects whose plasma glucose blood level or OGTT glucose blood level is beyond 2SD by a statistical analysis.
Target sample size	15

Research contact person
Name of lead principal investigator	Seiichiro Aoe
Organization	Otsuma Women's University
Division name	Faculty of Home Economics
Address	12 Sanban-cho, Chiyoda-ku, Tokyo 102-8357, Japan
TEL	03-5275-6048
Email	s-aoe@otsuma.ac.jp

Public contact
Name of contact person	Naoshi Kamata
Organization	GUN EI Chemical Industry CO., LTD.
Division name	Foodstuffs Group
Address	700 Shukuorui-machi, Takasaki-shi, Gunma 370-0032, Japan
TEL	027-353-1847
Homepage URL
Email	n-kamata@gunei-chemical.co.jp

Sponsor
Institute	GUN EI Chemical Industry CO., LTD.
Institute
Department

Funding Source
Organization	GUN EI Chemical Industry 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	医療法人樹心会　角田病院（群馬県）

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 20 Day
Anticipated trial start date	2016 Year 02 Month 22 Day
Last follow-up date	2016 Year 03 Month 25 Day
Date of closure to data entry	2016 Year 04 Month 11 Day
Date trial data considered complete	2016 Year 04 Month 20 Day
Date analysis concluded	2016 Year 04 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 04 Day
Last modified on	2016 Year 09 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024060