UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038670 |
|---|---|
| Receipt number | R000044074 |
| Scientific Title | Exploratory single center standard diet comparison open-label Randomized Crossover trial for the effects of Mochi-Rice for endocrine after meals. |
| Date of disclosure of the study information | 2020/01/01 |
| Last modified on | 2022/01/31 16:25:13 |
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Basic information
Public title
The effects of Mochi-Rice for endocrine after meals.
Acronym
The effects of Mochi-Rice for endocrine after meals.
Scientific Title
Exploratory single center standard diet comparison open-label Randomized Crossover trial for the effects of Mochi-Rice for endocrine after meals.
Scientific Title:Acronym
Exploratory single center standard diet comparison open-label Randomized Crossover trial for the effects of Mochi-Rice for endocrine after meals.
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of Mochi-Rice for endocrine after meals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose, CPR, glucagon, GIP, GLP-1
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
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
To eat standard diet
Interventions/Control_2
To eat Mochi rice diet.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy volunteer
Key exclusion criteria
None
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Michiaki |
| Middle name | |
| Last name | Fukui |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Endocrinology and Metabolism
Zip code
6028566
Address
465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku
TEL
+81-75-251-5505
michiaki@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Masahide |
| Middle name | |
| Last name | Hamaguchi |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Endocrinology and Metabolism
Zip code
6028566
Address
465, Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku
TEL
+81-75-251-5505
Homepage URL
mhama@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
4 universities cooperation study support projects (public offering type)
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Kyoto Prefectural University of Medicine
Address
Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, 602-8566
Tel
075-251-5337
rinri@koto.kpu-m.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 01 | 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
10
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
| 2019 | Year | 12 | Month | 31 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 24 | Day |
Last modified on
| 2022 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044074
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/11/02 | 研究計画書モチ米v9.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
