UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037449 |
|---|---|
| Receipt number | 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 09:25:20 |
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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
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
koichi.hashimoto@md.tsukuba.ac.jp
Sponsor or person
Institute
Clinical and translatnal methodology,
Fuculty of Medicine,
University of Tsukuba
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042633
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
