UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053092 |
|---|---|
| Receipt number | R000060586 |
| Scientific Title | Development of a vegetable intake method useful for blood glucose control -Verification of the vegetable juices consumption immediately before a meal on postprandial blood glucose levels- |
| Date of disclosure of the study information | 2023/12/15 |
| Last modified on | 2023/12/13 17:37:26 |
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Basic information
Public title
Development of a vegetable intake method useful for blood glucose control
-Verification of the vegetable juices consumption immediately before a meal on postprandial blood glucose levels-
Acronym
Development of a vegetable intake method useful for blood glucose control
-Verification of the vegetable juices consumption immediately before a meal on postprandial blood glucose levels-
Scientific Title
Development of a vegetable intake method useful for blood glucose control
-Verification of the vegetable juices consumption immediately before a meal on postprandial blood glucose levels-
Scientific Title:Acronym
Development of a vegetable intake method useful for blood glucose control
-Verification of the vegetable juices consumption immediately before a meal on postprandial blood glucose levels-
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of consumption of vegetable juices on postprandial blood glucose levels.
Basic objectives2
Others
Basic objectives -Others
The endpoint will be the usefulness of vegetable juices intake in controlling blood glucose.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The peak blood glucose values after ingestion of test food minus values before ingestion and the incremental area under the curve calculated from the changes of blood glucose levels
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
1.test meal A, 2.test meal B, 3.test meal C, 4.test meal A, 5.test meal B, 6.test meal C.
Interventions/Control_2
1.test meal B, 2.test meal C, 3.test meal A, 4.test meal B, 5.test meal C, 6.test meal A.
Interventions/Control_3
1.test meal C, 2.test meal A, 3.test meal B, 4.test meal C, 5.test meal A, 6.test meal B.
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
Male and female over 20 years old
Key exclusion criteria
1) Persons undergoing treatment for diabetes or equivalent medical treatment (medication for blood glucose control, insulin injections, etc.).
2) Persons with food allergies to the test food.
3) Persons with implanted medical devices such as pacemakers.
4) Those who are scheduled to undergo X-rays, MRI, CT scans, etc. during the study period.
5) Any other person who is deemed inappropriate by the principal investigator.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Ushida |
Organization
KAGOME CO., LTD.
Division name
Diet & Well-being Research Institute
Zip code
3292762
Address
17, Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287362935
yusuke_ushida@kagome.co.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Ushida |
Organization
KAGOME Co., LTD
Division name
Diet & Well-being Research Institute
Zip code
3292762
Address
17, Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287362935
Homepage URL
yusuke_ushida@kagome.co.jp
Sponsor or person
Institute
KAGOME Co., LTD
Institute
Department
Personal name
Funding Source
Organization
KAGOME Co., LTD
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagome Co.,LTD. Research Ethics Review Committee
Address
3-21-1 Nihonbashihamacho. chuo-ku, Tokyo
Tel
0356238501
Takuji_Hayakawai@kagome.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2023-R21
Org. issuing International ID_1
Kagome Co.,LTD. Research Ethics Review Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
カゴメ株式会社総合研究所(栃木県)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 15 | 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 | 10 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 30 | 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 | 12 | Month | 13 | Day |
Last modified on
| 2023 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060586
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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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