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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033478
Receipt No. 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 2019/01/21

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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
Middle name
Last name Kenichi Watanabe
Organization Niigata Bio-Research Park, Inc
Division name Advisor
Zip code
Address 316-2 Higashijima, Akiha-ku, Niigata, 956-0841, Japan
TEL 0250-25-1196
Email wataken@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Niigata Bio-Research Park, Inc
Organization Niigata Bio-Research Park, Inc
Division name Business promotion division
Zip code
Address 316-2 Higashijima, Akiha-ku, Niigata, 956-0841, Japan
TEL 0250-25-1196
Homepage URL
Email goto@nbrp.co.jp

Sponsor
Institute Niigata Bio-Research Park, Inc
Institute
Department

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
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

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
2019 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038004

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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