UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Measurement study on Glycemic index of amazake made from rice malt
Title of the study (Brief title)	Measurement study on Glycemic index of amazake made from rice malt
Region	Japan

Condition
Condition	Healthy Adults
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Measurement of glycemic index (GI) of amazake made from rice malt
Basic objectives2	Efficacy
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	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	TRELAN-G50, blood samples drawn at 15, 30, 45, 60, 90, 120 min after consumption - wash out period (more than 1 day), rice-malt amazake 300ml, blood samples drawn at 15, 30, 45, 60, 90, 120 min after consumption - wash out period (more than 1 day) - rice-malt amazake 300ml, blood samples drawn at 15, 30, 45, 60, 90, 120 min after consumption
Interventions/Control_2
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	20 years-old <=
Age-upper limit	50 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Persons whose fasting plasma glucose 70-110mg/dl 2.Persons whose body mass weight is 30 or less. 3.Persons who do not have impaired glucose tolerance in the past one year examination. 4.Persons who are not taking drugs such as antihypertensive agents. 5.Persons who received sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, agreed to participate with a written document.
Key exclusion criteria	1.Persons who have diabetes. 2.Persons who are pregnant or breastfeeding. 3.Persons who are allergic to the test food. 4.Persons who are judged as inappropriate for subjects by chief investigator.
Target sample size	10

Research contact person
Name of lead principal investigator	Mariko Uehara
Organization	Tokyo University of Agriculture
Division name	Faculty of Applied Bioscience
Address	1-1-1, Sakuragaoka, Setagaya-city, Tokyo
TEL	03-5477-2252
Email	mari@nodai.ac.jp

Public contact
Name of contact person	Nobuyuki Takahashi
Organization	Tokyo University of Agriculture
Division name	Faculty of Applied Bioscience
Address	1-1-1, Sakuragaoka, Setagaya-city, Tokyo
TEL	03-5477-2584
Homepage URL
Email	nt204885@nodai.ac.jp

Sponsor
Institute	Tokyo University of Agriculture Faculty of Applied Bioscience
Institute
Department

Funding Source
Organization	Marukome Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Marukome Co.,Ltd.
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	2019 Year 06 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 05 Month 01 Day
Anticipated trial start date	2018 Year 07 Month 01 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	2018 Year 06 Month 07 Day
Last modified on	2018 Year 07 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037515