UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000037449
Receipt No. R000042633
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-
Date of disclosure of the study information 2019/08/02
Last modified on 2020/07/22

* 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 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/ctr_e/ctr_view.cgi?recptno=R000042633

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.