UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study about hyperglycemia inhibiting effect after meal of Agave Syrup.
Title of the study (Brief title)	GI of Agave Syrup
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	GI value of agave nectar is said to 21, which is an inspection values in Canada. In the study, the research subject is the Japanese juvenile adult women, again to confirm whether there is a postprandial hyperglycemia inhibitory effect on agave nectar, Japanese cuisine is prepared with a sweetener, which is commonly used in Japan , go also examined the presence of postprandial hyperglycemia suppression effect. Japanese cuisine is characterized of using a lot of sweetener in comparison with the other dishes. Its Japanese The use of agave nectar is low GI for cooking, not only diet for type 2 diabetes, it is considered useful for a wide maintenance and improvement of public health.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	12 days
Key secondary outcomes

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	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Food
Interventions/Control_1	Glucose 50g intake three times Agave nectar intake three times Japanese cuisine eating 3 times Japanese cuisine eating three times where the flavored with agave nectar
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

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	20 years-old <=
Age-upper limit	22 years-old >=
Gender	Female
Key inclusion criteria	BMI30 below
Key exclusion criteria	Impaired glucose tolerance
Target sample size	10

Research contact person
Name of lead principal investigator	AKIYAMA Kumiko
Organization	Showa Women's University
Division name	Department of Human health and Design
Address	1-7-57 Taishido, Setagaya-ku, Tokyo, Japan
TEL	+81(3)3411-6237
Email	akiyama@swu.ac.jp

Public contact
Name of contact person	AKIYAMA Kumiko
Organization	Showa Women's University
Division name	Department of Human health and Design
Address	1-7-57 Taishido, Setagaya-ku, Tokyo, Japan
TEL	+81(3)3411-6237
Homepage URL
Email	akiyama@swu.ac.jp

Sponsor
Institute	Showa Women's 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	Showa Women's University
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	昭和女子大学

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 05 Month 25 Day
Anticipated trial start date	2015 Year 06 Month 15 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 05 Month 26 Day
Last modified on	2016 Year 05 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020499