UMIN-CTR Clinical Trial

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
Email	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
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	Niigata Bio-Research Park, Inc
Address	316-2 Higashijima, Akiha-ku, Niigata, 956-0841, Japan
Tel	0250-25-1196
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038004