UMIN-CTR Clinical Trial

Basic information
Public title	Examination of the efficacy of the high gamma PGA natto on the suppression of postprandial glucose elevation by single-dose test.
Acronym	The single-dose test of the high gamma PGA natto.
Scientific Title	Examination of the efficacy of the high gamma PGA natto on the suppression of postprandial glucose elevation by single-dose test.
Scientific Title:Acronym	The single-dose test of the high gamma PGA natto.
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To examine the efficacy of the high gamma PGA natto on the suppression of postprandial glucose elevation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Incremental area under the curve of plasma glucose (0-120 min)
Key secondary outcomes	1.Plasma glucose level(0-120 min) 2.Plasma insulin level(0-120 min) 3.Organoleptic evaluation(eating quality of test meal)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Low gamma PGA natto
Interventions/Control_2	High gamma PGA natto
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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	1.BMI not less than 18.5 kg/m2, under 25.0 kg/m2. 2.FPG less than 126 mg/dL and HbA1c less than 6.5% and 2-hour post-75 g oral glucose tolerance test plasma glucose levels less than 200 mg/dL. 3.Capable of giving informed consent.
Key exclusion criteria	1. Subjects who are treated for diabetes. 2. Subjects who are taking medications for dislipidemia, hypertention, and anemia. 3. Subjects who are taking warfarin. 4. Subjects who are habitually taking medication and/or supplement (including "food for specified health use", and "foods with function claims") that affect glucose metabolism. 5.Subjects who are diagnosed for anemia or have treatment history for anemia. 6. Subjects who are enrollment in another interventional study 7. Subjects who were recognized unsuitable for this study by the Investigator.
Target sample size	20

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Koichi Hashimoto
Organization	University of Tsukuba, Faculty of Medicene
Division name	Course of clinical research and regional innovation donated by the Japan Agriculture Ibaraki Public Welfare Federation
Zip code
Address	1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL	029-853-3064
Email	koichi.hashimoto@md.tsukuba.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Koichi Hashimoto
Organization	University of Tsukuba, Faculty of Medicene
Division name	Course of clinical research and regional innovation donated by the Japan Agriculture Ibaraki Public
Zip code
Address	1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL	029-853-3064
Homepage URL
Email	koichi.hashimoto@md.tsukuba.ac.jp

Sponsor
Institute	Course of clinical research and regional innovation donated by the Japan Agriculture Ibaraki Public Welfare Federation Fuculty of Medicine University of Tsukuba
Institute
Department

Funding Source
Organization	Course of clinical research and regional innovation donated by the Japan Agriculture Ibaraki Public Welfare Federation Fuculty of Medicine University of Tsukuba
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	1.Takanofoods Co., Ltd. 2.Industrial technology insutitute of Ibaraki prefecture 3.National agriculture and food research organization, food research institute
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	筑波大学附属病院（茨城県）

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 30 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	2017 Year 11 Month 30 Day
Date of IRB	2017 Year 12 Month 04 Day
Anticipated trial start date	2017 Year 12 Month 11 Day
Last follow-up date	2018 Year 04 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 11 Month 30 Day
Last modified on	2019 Year 05 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034477