UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046553 |
|---|---|
| Receipt number | R000053113 |
| Scientific Title | Effect of low-carbohydrate menu on physiological effects |
| Date of disclosure of the study information | 2022/02/01 |
| Last modified on | 2024/07/08 09:05:25 |
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Basic information
Public title
Effect of low-carbohydrate menu on physiological effects
Acronym
Effect of low-carbohydrate menu on physiological effects
Scientific Title
Effect of low-carbohydrate menu on physiological effects
Scientific Title:Acronym
Effect of low-carbohydrate menu on physiological effects
Region
| Japan |
Condition
Condition
healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
As a measure against blood glucose spikes, control of carbohydrate intake and methods of intake have been proposed. The purpose of this study is to propose the necessary dietary method and meal itself to moderate the increase in blood glucose level, and to investigate the increase in blood glucose level in eating out and prepared meal menus. The results of this study can be disseminated to society regarding methods for controlling blood glucose levels by eating out to limit carbohydrates, and are considered to be significant.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjects have within 10 minutes while chewing about 30 times, and measure the blood glucose level before meals and 15, 30, 45, 60, 90, 120 minutes after the start of meals.
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Eating Out Low Carbohydrate Meals
Once
Interventions/Control_2
Ready-to-eat low carbohydrate meal
Once
Interventions/Control_3
Ready-to-eat normal meal
Once
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
healthy
Key exclusion criteria
Pregnant, lactating and menstruating women.
Impaired glucose tolerance on examination for the past year.
Take drugs such as antihypertensive drugs.
Fasting blood glucose is 100 mg / dl or more.
Allergic to wheat, soybeans, pork, beef, etc.
belonging to a research team.
Target sample size
20
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
TEL
0774383750
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
TEL
0774383750
Homepage URL
hayashi.yukako.7s@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Zensho holdings
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
Kyoto University
Address
Gokasho Uji
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
| 2022 | Year | 02 | 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
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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2022 | Year | 01 | Month | 05 | Day |
Last modified on
| 2024 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053113
