UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000805 |
|---|---|
| Receipt number | R000000938 |
| Scientific Title | Investigation the possible anti-diabetic effect of water-solubule dietary fiber in human. |
| Date of disclosure of the study information | 2007/08/23 |
| Last modified on | 2008/09/02 15:16:19 |
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Basic information
Public title
Investigation the possible anti-diabetic effect of water-solubule dietary fiber in human.
Acronym
Possible anti-diabetic effect of dietary fiber.
Scientific Title
Investigation the possible anti-diabetic effect of water-solubule dietary fiber in human.
Scientific Title:Acronym
Possible anti-diabetic effect of dietary fiber.
Region
| Japan |
Condition
Condition
Diabetes Mellitus
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of new biomarkers
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum concentrations of new biomarkers
Glucose tolerance
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
water-solubule dietary fiber
Interventions/Control_2
placebo
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
| 65 | years-old | > |
Gender
Male
Key inclusion criteria
BMI 23-30
Waist size 85-110cm
Key exclusion criteria
diabetes
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshikazu Yoshikawa |
Organization
Kyoto Prefectural University of Medicine
Division name
Immunology and Internal Medicine
Zip code
Address
465 Kajii-cho Kawaramachi-Hirokoji Kamigyo-ku,Kyoto
TEL
075-251-5505
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Sato |
Organization
Biomarker Science Co., Ltd.
Division name
Business Office
Zip code
Address
TEL
06-6943-1011
Homepage URL
satoh@biomarker.co.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding 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
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 08 | Month | 23 | 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
| 2007 | Year | 08 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2008 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2008 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 04 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2007 | Year | 08 | Month | 23 | Day |
Last modified on
| 2008 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000938
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
