UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017686 |
|---|---|
| Receipt number | 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 18:33:36 |
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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
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
akiyama@swu.ac.jp
Sponsor or person
Institute
Showa Women's University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020499
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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