UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039159 |
|---|---|
| Receipt number | R000044661 |
| Scientific Title | Suppressive effect of the lactic acid bacterium on the postprandial blood glucose level |
| Date of disclosure of the study information | 2020/01/18 |
| Last modified on | 2020/01/15 10:51:44 |
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Basic information
Public title
Suppressive effect of the lactic acid bacterium on the postprandial blood glucose level
Acronym
Suppressive effect of the lactic acid bacterium on the postprandial blood glucose level
Scientific Title
Suppressive effect of the lactic acid bacterium on the postprandial blood glucose level
Scientific Title:Acronym
Suppressive effect of the lactic acid bacterium on the postprandial blood glucose level
Region
| Japan |
Condition
Condition
Diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of lactic acid bacterium heat-sterilized at 80 degree centigrade on postprandial blood glucose elevation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postprandial blood glucose levels
Area under the curve(AUC) of postprandial blood glucose levels
Key secondary outcomes
Postprandial insulin levels
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
A sucrose tolerance test is conducted at intervals of 3 days or more under physiological saline intake(single ingestion 10mL) and lactic acid bacteria #Ef-1 strain intake(heat-sterilized bacteria at 80 degree centigrade, single ingestion 10mL).
Interventions/Control_2
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Subjects who are the age of 20 to less than the age of 60 years old
2) Healthy adult male or female
3) Subjects who are non-diabetic
4) Subjects who can make self-judgment and are voluntarily giving written informed consent
Key exclusion criteria
1) Subjects using medical products due to any illness
2) Subjects with a current or past medical history that may affect the test results
3) Subjects who could cause allergic symptoms related to the test products
4) Subjects who regularly use health foods or supplements that may affect glucose metabolism
5) Subjects who have used any drugs within one week prior to the current clinical trial
6) Subjects who have participated in other clinical trials within the last four weeks prior to the current clinical trial
7) Subjects who are judged by the investigator to be inappropriate for participation in this study
Target sample size
2
Research contact person
Name of lead principal investigator
| 1st name | Masayoshi |
| Middle name | |
| Last name | Ito |
Organization
Yotsuya Medical Cube
Division name
Gastroenterology
Zip code
102-0084
Address
7-7 Nibancho, Chiyoda-ku,Tokyo
TEL
0332610401
ma-itoh@mcube.jp
Public contact
Name of contact person
| 1st name | Masayoshi |
| Middle name | |
| Last name | Ito |
Organization
Yotsuya Medical Cube
Division name
Gastroenterology
Zip code
102-0084
Address
7-7 Nibancho, Chiyoda-ku,Tokyo
TEL
0332610401
Homepage URL
ma-itoh@mcube.jp
Sponsor or person
Institute
Yotsuya Medical Cube
Institute
Department
Personal name
Funding Source
Organization
Genome Pharmaceuticals Institute Co.,Ltd.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Pharmaspur Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yotsuya Medical Cube
Address
7-7 Nibancho, Chiyoda-ku,Tokyo
Tel
0332610401
ma-itoh@mcube.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
| 2020 | Year | 01 | Month | 18 | 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 | 12 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 01 | Month | 15 | Day |
Last modified on
| 2020 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044661
| Research Plan | |
|---|---|
| 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 |
