UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052934 |
|---|---|
| Receipt number | R000060397 |
| Scientific Title | Effects of Dietary Pattern on Physiological Function |
| Date of disclosure of the study information | 2024/01/05 |
| Last modified on | 2023/11/28 18:13:11 |
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Basic information
Public title
Effects of Dietary Pattern on Physiological Function
Acronym
Physiological Effects of Dietary Pattern
Scientific Title
Effects of Dietary Pattern on Physiological Function
Scientific Title:Acronym
Physiological Effects of Dietary Pattern
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We have been working to propose the necessary dietary methods and the diet itself to slow the rise in blood glucose levels. Based on this knowledge, we will analyze blood glucose control by dietary form.
Basic objectives2
Others
Basic objectives -Others
Building a white rice menu
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood glucose before and from 10 minutes to 120 minutes after the start of a meal
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Sushi
Interventions/Control_2
Sushi(half rice)
Interventions/Control_3
rice
Interventions/Control_4
half rice
Interventions/Control_5
half rice followed sushi topping
Interventions/Control_6
sushi topping followed half rice
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
Key exclusion criteria
Pregnant, lactating, or menstruating women on the same day.
Allergic to shrimp, crab, eggs, squid, salmon roe, salmon, wheat, soy, mackerel, chicken, apple, or any other food tested.
Taking anticoagulants.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Yukako |
| Middle name | |
| Last name | Hayashi |
Organization
Kyoto University
Division name
Graduate School of Agriculture
Zip code
611-0011
Address
Gokasho, Uji, Kyoto
TEL
0774-38-3750
hayashi.yukako.7s@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukako |
| Middle name | |
| Last name | Hayashi |
Organization
Kyoto University
Division name
Graduate School of Agriculture
Zip code
611-0011
Address
Gokasho, Uji , Kyoto
TEL
0774-38-3750
Homepage URL
hayashi.yukako.7s@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Univeristy
Address
Gokasho, Uji, Kyoto
Tel
0774383750
hayashi.yukako.7s@kyoto-u.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
| 2024 | Year | 01 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 28 | Day |
Last modified on
| 2023 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060397
| 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 |
