UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028124 |
|---|---|
| Receipt number | R000032192 |
| Scientific Title | Optimization test of lowering effects on blood glucose level of alginate-containing noodles |
| Date of disclosure of the study information | 2017/07/07 |
| Last modified on | 2017/11/06 12:15:39 |
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Basic information
Public title
Optimization test of lowering effects on blood glucose level of alginate-containing noodles
Acronym
Effects on blood glucose level of alginate-containing noodles
Scientific Title
Optimization test of lowering effects on blood glucose level of alginate-containing noodles
Scientific Title:Acronym
Effects on blood glucose level of alginate-containing noodles
Region
| Japan |
Condition
Condition
Hyperglycemia
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation for the effect on blood glucose level of alginate-containing noodles.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effect on blood glucose level
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Tested group 1(concentration 1)
For 3 or 4 weeks
Once a week
Interventions/Control_2
Tested group 2(concentration 2)
For 3 or 4 weeks
Once a week
Interventions/Control_3
Placebo group
For 3 or 4 weeks
Once a week
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy male and female volunteer over the age of 18
Key exclusion criteria
Person that
1. feels this study is inconvenient to everyday life.
2. takes medications such as hypoglycemic drugs. (Person undergoing treatment for diabetes)
3. has been diagnosed by a doctor that abnormally blood glucose level.
4. has some diseases and under medication treatments.
5. may cause allergic symptoms with regard to test noodles (wheat flour etc.).
6. is liable to cause allergic symptoms with alcohol.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuo Ogihara |
Organization
Takasaki University of Health and Welfare
Division name
Graduate School of Pharmaceutical Sciences
Zip code
Address
60 Nakaorui-machi, Takasaki-shi, Gunma, Japan
TEL
027-352-1180
togihara@takasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takako Kato |
Organization
Takasaki University of Health and Welfare
Division name
Faculty of Pharmacy
Zip code
Address
60 Nakaorui-machi, Takasaki-shi, Gunma, Japan
TEL
027-352-1180
Homepage URL
katou-t@takasaki-u.ac.jp
Sponsor or person
Institute
Takasaki University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Kendai Translational Research Center
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
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
| 2017 | Year | 07 | Month | 07 | 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
| 2017 | Year | 06 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 22 | 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
| 2017 | Year | 07 | Month | 07 | Day |
Last modified on
| 2017 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032192
| 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 |
