UMIN-CTR Clinical Trial

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

Condition
Condition	Healthy subjects
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

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

Assessment
Primary outcomes	Incremental area under the curve of plasma glucose (0-30 min)
Key secondary outcomes	1.Incremental area under the curve of plasma glucose (0-15, 0-45, 0-60, 0-90, 0-120 min) 2.The level and change from baselaine of plasma glucose (0-15, 0-30, 0-45, 0-60, 0-90, 0-120 min) 3.The level and change from baseline of plasma insulin (0-15, 0-30, 0-45, 0-60, 0-90, 0-120 min) 4.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
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	[At the primary registration] 1. Men and postmenopausal women aged 20-70 years old. 2. BMI not less than 18.5 kg/m2, under 25.0 kg/m2. 3. FPG less than 126 mg/dL and HbA1c less than 6.5%. 4. Subjects who can maintain an everyday lifestyle during study period constantly 5. Capable of giving informed consent. [At the secondary registration] Subjects who meet the following conditions after the meal loading test with 150g of white rice, that performed after primary registration. 1. The levels of casual plasma glucose less than 200 mg/dL. 2. Priority is given to those with a plasma glucose levels more than 140 mg/dL at post-30 min or at any point of time.
Key exclusion criteria	[At the primary registration] 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 difficult to collect blood in health checkup and so on oftenly. 7. Subjects who are enrollment in another interventional study. 8. Subjects who have suspected food allergy to test meal 9. Subjects who were recognized unsuitable for this study by the Investigator. [At the secondary registration] 1. Subjects who are confirmed to be difficult to collect blood during continuous blood collection using indwelling needle 2. Subjects who were recognized unsuitable for this study by the Investigator.
Target sample size	36

Research contact person
Name of lead principal investigator	1st name Koichi Middle name Last name Hashimoto
Organization	University of Tsukuba, Faculty of Medicene
Division name	Clinical and translatnal methodology
Zip code	3050005
Address	1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL	029-853-3064
Email	koichi.hashimoto@md.tsukuba.ac.jp

Public contact
Name of contact person	1st name Koichi Middle name Last name Hashimoto
Organization	University of Tsukuba, Faculty of Medicene
Division name	Clinical and translatnal methodology
Zip code	3050005
Address	1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
TEL	029-853-3064
Homepage URL
Email	koichi.hashimoto@md.tsukuba.ac.jp

Sponsor
Institute	Clinical and translatnal methodology, Fuculty of Medicine, University of Tsukuba
Institute
Department

Funding Source
Organization	Ministry of Agriculture, Forestry and Fisheries
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 innovation center of Ibaraki prefecture. 3. National agriculture and food research organization, food research institute.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Clinical Research Ethics Committee of University of Tsukuba Hospital
Address	1-1-1 Tennodai, Tsukuba, Ibaraki, Japan
Tel	029-853-3914
Email	chiken@un.tsukuba.ac.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	2019 Year 08 Month 02 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	2019 Year 07 Month 17 Day
Date of IRB	2019 Year 07 Month 24 Day
Anticipated trial start date	2019 Year 08 Month 02 Day
Last follow-up date	2019 Year 11 Month 27 Day
Date of closure to data entry	2020 Year 01 Month 10 Day
Date trial data considered complete	2020 Year 01 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 07 Month 22 Day
Last modified on	2020 Year 07 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000042633