UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the glucose metabolism-improving effect of the 12-week intake of beverages containing lactic acid bacteria
Title of the study (Brief title)	Study of the glucose metabolism-improving effect of the 12-week intake of beverages containing lactic acid bacteria
Region	Japan

Condition
Condition	Hyperglycemia
Classification by specialty	Medicine in general Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of reducing blood glucose levels by the intake of lactic acid bacteria
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase II

Assessment
Primary outcomes	Fasted blood glucose level Glycoalbumin Insulin resistance index
Key secondary outcomes	Blood fat level Body fat percentage Blood inflammatory cytokines

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	12-week intake of the test food
Interventions/Control_2	12-week intake of the placebo food
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	35 years-old <=
Age-upper limit	74 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Subjects giving written informed consent 2. Healthy men and women of 35 to 74 years age and whose fasted blood glucose levels were 110 mg/dl to 126 mg/dl at the screening period
Key exclusion criteria	1. Subjects in the drug therapy or in the hospital care 2. Sever systemic diseases affecting the results of this study 3. Subjects with an immunodeficiency 4. Subjects with a previous history or merger of malignant tumors 5. Subjects in pregnancy or in nursing 6. Subjects with a habit of intake more than twice in a week of fermented milk or lactic fermenting beverage in three months before screening test 7. Constant use of oral medication or supplements affecting glucese or lipid matabolism in three months before screening test 8. Subjects with food allergy or medicine allergy 9. Subjects who drink a lot of alcohol 10. Subjects who participated in other clinical trials within one month before the agreement of participants in this study 11. Subjects who are judged as unsuitable for the study by the investigator for other reasons
Target sample size	130

Research contact person
Name of lead principal investigator	Masao Matsuoka
Organization	HUMA R&D CORP
Division name	Clinical Depelopment Division
Address	9F RBM Hamamatsucho Build. 1-27-12 Hamamatsucho Minato-ku, Tokyo 105-0013 Japan
TEL	81-3-3431-1260
Email	matsuoka@huma-c.co.jp

Public contact
Name of contact person	Masao Matsuoka
Organization	HUMA R&D CORP
Division name	Clinical Depelopment Division
Address	9F RBM Hamamatsucho Build. 1-27-12 Hamamatsucho Minato-ku, Tokyo 105-0013 Japan
TEL	81-3-3431-1260
Homepage URL
Email	matsuoka@huma-c.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	Food Microbiology Research Laboratories, Meiji Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

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

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 20 Day
Anticipated trial start date	2016 Year 08 Month 18 Day
Last follow-up date	2017 Year 12 Month 31 Day
Date of closure to data entry	2018 Year 02 Month 20 Day
Date trial data considered complete	2018 Year 02 Month 20 Day
Date analysis concluded	2018 Year 03 Month 30 Day

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

Management information
Registered date	2016 Year 08 Month 03 Day
Last modified on	2018 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027038