UMIN-CTR Clinical Trial

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
Email	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
Email	ma-itoh@mcube.jp

Sponsor
Institute	Yotsuya Medical Cube
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044661