UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024338
Receipt number 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 14:39:20

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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 or person

Institute

Pharmaspur Inc.

Institute

Department

Personal name



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

Value
https://center6.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