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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024338
Receipt No. R000028004
Scientific Title Study of Lactic Acid Bacteria for Inhibition of Blood Sugar Elevation after Sucrose Intake in Human
Date of disclosure of the study information 2016/10/08
Last modified on 2017/01/05

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Basic information
Public title Study of Lactic Acid Bacteria for Inhibition of Blood Sugar Elevation after Sucrose Intake in Human
Acronym Study of Lactic Acid Bacteria for Inhibition of Blood Sugar Elevation after Sucrose Intake in Human
Scientific Title Study of Lactic Acid Bacteria for Inhibition of Blood Sugar Elevation after Sucrose Intake in Human
Scientific Title:Acronym 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
1st name
Middle name
Last name Setsuo Hasegawa
Organization Pharmaspur Inc.
Division name -
Zip code
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
1st name
Middle name
Last name Michiko Kainuma
Organization Pharmaspur Inc.
Division name -
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Completed
Date of protocol fixation
2016 Year 09 Month 21 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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