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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000017686
Receipt No. R000020499
Scientific Title Study about hyperglycemia inhibiting effect after meal of Agave Syrup.
Date of disclosure of the study information 2015/06/01
Last modified on 2016/05/26

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Basic information
Public title Study about hyperglycemia inhibiting effect after meal of Agave Syrup.
Acronym GI of Agave Syrup
Scientific Title Study about hyperglycemia inhibiting effect after meal of Agave Syrup.
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name AKIYAMA Kumiko
Organization Showa Women's University
Division name Department of Human health and Design
Zip code
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
1st name
Middle name
Last name AKIYAMA Kumiko
Organization Showa Women's University
Division name Department of Human health and Design
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2015 Year 05 Month 25 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000020499

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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