UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011343
Receipt number R000013293
Scientific Title Increased inhibitory effect confirmation of postprandial glucose level by powder was wheat fermented with Bacillus.
Date of disclosure of the study information 2013/08/01
Last modified on 2014/09/11 22:40:48

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Basic information

Public title

Increased inhibitory effect confirmation of postprandial glucose level by powder was wheat fermented with Bacillus.

Acronym

Increased inhibitory effect confirmation of postprandial glucose level by powder was wheat fermented with Bacillus.

Scientific Title

Increased inhibitory effect confirmation of postprandial glucose level by powder was wheat fermented with Bacillus.

Scientific Title:Acronym

Increased inhibitory effect confirmation of postprandial glucose level by powder was wheat fermented with Bacillus.

Region

Japan


Condition

Condition

impaired glucose tolerance

Classification by specialty

Medicine in general Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Compare the postprandial glucose level and placebo.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison between groups of variation of 30, 60, 120 minutes after a meal.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit


Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Administered the Test article(wheat fermented with Bacillus.) .

Interventions/Control_2

Administered the Placebo(wheat fermented with Bacillus miyagino-natto.).

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


 Not applicable

Gender

Male and Female

Key inclusion criteria

Person of Impaired glucose tolerance.

Key exclusion criteria

1)Allergy symptoms have not been confirmed(wheat allergy in particular).
2)A person who is suffering from connective tissue disease or rheumatic condition.
3)Those who need an antihypertensive therapy emergency.
4)Patient with symptoms of cerebrovascular disease.
5)A person with a history of cardiac infarction and heart failure patients.
6)Those with kidney damage or liver failure.
7)Anemic patient.
8)Those who may be pregnant or possible pregnant.
9)The person who is unsuitable for the entry judged by a doctor.

Target sample size

13


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masakatsu Nishikawa, M.D.,Ph.D.

Organization

Mie University, Graduate School of Medicine

Division name

Institute of Human Research Promotion and Drug Development

Zip code


Address

2-174 Edobashi, Tsu, Mie 514-8507, Japan

TEL

0592321111

Email

nisikawa@clin.medic.mie-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Koji Umeda,Ph.D.

Organization

KSK Laboratories,Inc.

Division name

representative

Zip code


Address

t.c.p 4F,7-15 Daimon, Tsu, Mie 514-0027, Japan

TEL

0592538091

Homepage URL


Email

umeda@ksk-lab.co.jp


Sponsor or person

Institute

Mie University, Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

KSK Laboratories,Inc.

Organization

Division

Category of Funding Organization

Profit organization

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

三重大学医学部附属病院・三重大学総合研究棟２


Other administrative information

Date of disclosure of the study information

2013 Year 08 Month 01 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

2013 Year 08 Month 02 Day

Date of IRB


Anticipated trial start date

2013 Year 10 Month 05 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

2013 Year 08 Month 01 Day

Last modified on

2014 Year 09 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013293


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name