UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033478 |
|---|---|
| Receipt number | R000038004 |
| Scientific Title | Study on postprandial blood glucose response after koji amazake intake in healthy subjects. |
| Date of disclosure of the study information | 2018/07/27 |
| Last modified on | 2021/12/13 14:33:58 |
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Basic information
Public title
Study on postprandial blood glucose response after koji amazake intake in healthy subjects.
Acronym
Study on postprandial blood glucose response after koji amazake intake in healthy subjects.
Scientific Title
Study on postprandial blood glucose response after koji amazake intake in healthy subjects.
Scientific Title:Acronym
Study on postprandial blood glucose response after koji amazake intake in healthy subjects.
Region
| Japan |
Condition
Condition
Healty volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of recommended intake patterns for koji amazake by clarification of the blood glucose response after the intake.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood glucose levels , insulin levels.
Key secondary outcomes
IAUCg , IAUCi
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test meal - 1 : Intake koji amazake (108mL) and water (150mL) > Washout period : one week > Test meal - 2 : Intake koji amazake (36mL) > Washout period : one week > Plasebo food : Intake glycated liquid of steamed rice (108mL) and water (150mL) .
Interventions/Control_2
Test meal - 2 : Intake koji amazake (36mL) and water(150mL) > Washout period : one week > Placebo food : Intake glycated liquid of steamed rice (108mL) and water(150mL) > Washout period : one week > Test meal - 1 : Intake koji amazake (108mL) and water (150mL) .
Interventions/Control_3
Placebo food : Intake glycated liquid of steamed rice (108mL) and water (150mL) > Washout period : one week > Test meal - 1 : Intake koji amazake (108mL) and water (150mL) > Washout period : one week > Test meal - 2 : Intake koji amazake (36mL) and water (150mL) .
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Fasting plasma glucose = < 126mg / dL.
2.Volunteer having screening test result and questionnaire result judged to be appropriate for this study by investigator.
Key exclusion criteria
1.Diabetes under medical treatment.
2.Volunteers having diseases (e.g. liver , kidney , heart , blood diseases , and infections requiring the notification.)
3.Volunteers received gastrectomy , enterectomy , and gastro-intestinal diseases , judged to be inappropriate for this study.
4.Pregnant , women having the possibility , and lactating women.
5.Paticipants in other clinical trial.
6.Volunteers rejected participating in this study by chief investigator.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Watanabe |
Organization
Niigata Bio-Research Park, Inc
Division name
Advisor
Zip code
956-0841
Address
316-2 Higashijima, Akiha-ku, Niigata, 956-0841, Japan
TEL
0250-25-1196
wataken@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Goto |
Organization
Niigata Bio-Research Park, Inc
Division name
Business promotion division
Zip code
956-0841
Address
316-2 Higashijima, Akiha-ku, Niigata, 956-0841, Japan
TEL
0250-25-1196
Homepage URL
goto@nbrp.co.jp
Sponsor or person
Institute
Niigata Bio-Research Park, Inc
Institute
Department
Personal name
Funding Source
Organization
Hakkaisan Brewery Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata Bio-Research Park, Inc
Address
316-2 Higashijima, Akiha-ku, Niigata, 956-0841, Japan
Tel
0250-25-1196
nbrp-food-navi@nbrp.co.jp
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
| 2018 | Year | 07 | Month | 27 | 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
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 27 | 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 | 07 | Month | 23 | Day |
Last modified on
| 2021 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038004
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
