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
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
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
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
