UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032906 |
|---|---|
| Receipt number | R000037515 |
| Scientific Title | Measurement study on Glycemic index of amazake made from rice malt |
| Date of disclosure of the study information | 2019/06/01 |
| Last modified on | 2018/07/05 12:34:55 |
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Basic information
Public title
Measurement study on Glycemic index of amazake made from rice malt
Acronym
Measurement study on Glycemic index of amazake made from rice malt
Scientific Title
Measurement study on Glycemic index of amazake made from rice malt
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Mariko Uehara |
Organization
Tokyo University of Agriculture
Division name
Faculty of Applied Bioscience
Zip code
Address
1-1-1, Sakuragaoka, Setagaya-city, Tokyo
TEL
03-5477-2252
mari@nodai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Takahashi |
Organization
Tokyo University of Agriculture
Division name
Faculty of Applied Bioscience
Zip code
Address
1-1-1, Sakuragaoka, Setagaya-city, Tokyo
TEL
03-5477-2584
Homepage URL
nt204885@nodai.ac.jp
Sponsor or person
Institute
Tokyo University of Agriculture
Faculty of Applied Bioscience
Institute
Department
Personal name
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)
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
Other administrative information
Date of disclosure of the study information
| 2019 | 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
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037515
