UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of the effect of lactic acid bacteria on glucose metabolism in subjects with borderline diabetes
Title of the study (Brief title)	Evaluation of the effect of lactic acid bacteria on glucose metabolism in subjects with borderline diabetes
Region	Japan

Condition
Condition	Healthy volunteers
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of Pediococcus pentosaceus LP28 on impaired glucose tolerance.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	12-week change in OGTT-2h
Key secondary outcomes	12-week changes in AUC, Cmax and Tmax of blood glucose and insulin in OGTT, insulinogenic index, FBS, HOMA-R, HbA1c, glycoalbumin, visceral fat area, body fat percentage, abdominal circumference

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of granulated powder containing Pediococcus pentosaceus LP28 and dextrin (2 g/day) for 12 weeks.
Interventions/Control_2	Intake of granulated powder of dextrin (2 g/day) for 12 weeks.
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	140<= OGTT-2h <200 mg/dL
Key exclusion criteria	1) HbA1c>=6.5% 2) Taking medicines or receiving health guidance for hypertension, diabetes, and/or hyperlipidemia 3) Taking drugs or functional food that may affect the trial 4) Participation in any clinical trial within 90 days of the commencement of the trial 5) In pregnancy or nursing a child 6) Judged as ineligible by clinical investigators
Target sample size	40

Research contact person
Name of lead principal investigator	Fumiko Higashikawa
Organization	Hiroshima University, Institute of Biomedical & Health Sciences
Division name	Project Research Center for Clinical Trial and Preventive Medicine
Address	Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
TEL	082-257-1533
Email	fumiko@hiroshima-u.ac.jp

Public contact
Name of contact person	Fumiko Higashikawa
Organization	Hiroshima University, Institute of Biomedical & Health Sciences
Division name	Project Research Center for Clinical Trial and Preventive Medicine
Address	Kasumi 1-2-3, Minami-ku, Hiroshima 734-8551, JAPAN
TEL	082-257-1533
Homepage URL
Email	fumiko@hiroshima-u.ac.jp

Sponsor
Institute	Hiroshima University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	広島大学病院（広島県）

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 02 Day
Anticipated trial start date	2017 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 08 Month 09 Day
Last modified on	2019 Year 01 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032736