UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030182
Receipt No. R000034477
Scientific Title Examination of the efficacy of the high gamma PGA natto on the suppression of postprandial glucose elevation by single-dose test.
Date of disclosure of the study information 2017/11/30
Last modified on 2019/05/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.