UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049115 |
|---|---|
| Receipt number | R000055951 |
| Scientific Title | A Study evaluating the effect of konnyaku-derived Ninja Paste on glucose tolerance |
| Date of disclosure of the study information | 2022/10/04 |
| Last modified on | 2023/04/05 09:04:46 |
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Basic information
Public title
A Study evaluating the effect of konnyaku-derived Ninja Paste on glucose tolerance
Acronym
A Study evaluating the effect of konnyaku-derived Ninja Paste on glucose tolerance
Scientific Title
A Study evaluating the effect of konnyaku-derived Ninja Paste on glucose tolerance
Scientific Title:Acronym
A Study evaluating the effect of konnyaku-derived Ninja Paste on glucose tolerance
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of konnyaku-derived Ninja Paste on improving glucose metabolism with changes in pre-meal intake time.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area under the curve of blood glucose levels after Oral Glucose Tolerance Test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects take control food 3times, After repeated intake, subjects take Oral Glucose Torerance Test to measure blood glucose levels.
Interventions/Control_2
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 and Female
Key inclusion criteria
1)Healthy male and female subjects whose ages are 20<=years old <65.
2)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
1)Subjects who are pregnant or lactating.
2)Subjects or subjects' families contracting diabetes.
3)Subjects whose fasting blood glucose is equivalent to or higher than 126mg/dL by a figure stick blood test.
4)Subjects with illness who are constantly taking certain drug medicine.
5)Subjects who have a food allergy.
6)Subjects with aichmophobia.
7)Subjects with extreme diarrhea.
8)Subjects who regularly use medicines, foods for specified health uses, and health foods that may affect the study.
9)Subjects who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tomiyo |
| Middle name | |
| Last name | Nakamura |
Organization
Ryukoku University
Division name
Department of Food Science and Human Nutrition
Zip code
520-2194
Address
1-5,Yokotani, Seta Oe-cho, Otsu, Shiga
TEL
077-566-5614
tomiyo@agr.ryukoku.ac.jp
Public contact
Name of contact person
| 1st name | Tomiyo |
| Middle name | |
| Last name | Nakamura |
Organization
Ryukoku University
Division name
Department of Food Science and Human Nutrition
Zip code
520-2194
Address
1-5,Yokotani, Seta Oe-cho, Otsu, Shiga
TEL
077-599-5614
Homepage URL
tomiyo@agr.ryukoku.ac.jp
Sponsor or person
Institute
Department of Food Science and Human Nutrition,Ryukoku University
Institute
Department
Personal name
Funding Source
Organization
Sydecas Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sydecas Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Rytukoku University
Address
1-5,Yokotani, Seta Oe-cho, Otsu, Shiga
Tel
077-543-7742
setaken@ad.ryukoku.ac.jp
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
龍谷大学
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 04 | 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
| 2022 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 04 | Day |
Last modified on
| 2023 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055951
| Research Plan | |
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| 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 |
