UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of Lactic Acid Bacteria for Inhibition of Blood Sugar Elevation after Sucrose Intake in Human
Title of the study (Brief title)	Study of Lactic Acid Bacteria for Inhibition of Blood Sugar Elevation after Sucrose Intake in Human
Region	Japan

Condition
Condition	Healthy adults Borderline diabetes Type 2 diabetes
Classification by specialty	Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Verify suppressive effect of postprandial glucose level elevation by lactic acid bacteria (viable and killed bacteria)
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood glucose level after the sucrose tolerance test Area under the curve for blood glucose level
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	Conduct sucrose tolerance test for both cases of intake and non-intake of lactic acid bacterium solution by 50ml (killed and viable bacteria) by taking an interval of about a week. Lactic acid bacterium intake ten minutes later
Interventions/Control_2	Conduct sucrose tolerance test for both cases of intake and non-intake of lactic acid bacterium solution by 50ml (killed and viable bacteria) by taking an interval of about a week. Lactic acid bacterium intake one day later
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
Key inclusion criteria	1) Japanese healthy (including borderline diabetes) male 2) Fasting blood sugar: Lower than 125 mg/dL 3) Subjects who is not a diabetes
Key exclusion criteria	1) HbA1c are more than 7.0% 2) Subjects using medical products 3) Subjects who could start having allergic symptom in relation to test products 4) Subjects who use health food and supplements affecting blood glucose 5) Heavy drinker of alcohol 6) Subjects who participated in other clinical trials within the last four weeks prior to the current clinical trial 7) Subjects who have participated in a testregarding to the said lactic acid bacteriain the past. 8) Subjects judged inappropriate for the study by the investigator.
Target sample size	30

Research contact person
Name of lead principal investigator	Setsuo Hasegawa
Organization	Pharmaspur Inc.
Division name	-
Address	Toyo Building, 1-2-10 Nihonbashi, Chuo-ku, Tokyo
TEL	03-6214-2670
Email	setsuo_hasegawa@pharmaspur.com

Public contact
Name of contact person	Michiko Kainuma
Organization	Pharmaspur Inc.
Division name	-
Address	Toyo Building, 1-2-10 Nihonbashi, Chuo-ku, Tokyo
TEL	03-6214-2670
Homepage URL
Email	michiko_kainuma@pharmaspur.com

Sponsor
Institute	Pharmaspur Inc.
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
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	医療法人社団　冠心会　大崎病院　東京ハートセンター　臨床薬理研究所

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 08 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 21 Day
Anticipated trial start date	2016 Year 11 Month 11 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	2016 Year 10 Month 07 Day
Last modified on	2017 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028004