UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055764 |
|---|---|
| Receipt number | R000063735 |
| Scientific Title | Verification of the effectiveness of dietary guidance program for promote of salt reduction and increased vegetables |
| Date of disclosure of the study information | 2024/10/08 |
| Last modified on | 2025/08/19 14:08:09 |
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Basic information
Public title
Verification of the effectiveness of dietary guidance program for promote of salt reduction and increased vegetables
Acronym
Verification of the effectiveness of dietary guidance program for promote of salt reduction and increased vegetables
Scientific Title
Verification of the effectiveness of dietary guidance program for promote of salt reduction and increased vegetables
Scientific Title:Acronym
Verification of the effectiveness of dietary guidance program for promote of salt reduction and increased vegetables
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification or the effectiveness of dietary guidance program on dietary status improvement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of change in the biological index A and B, and dietary status by dietary guidance program
Key secondary outcomes
The duration of changes in dietary status resulting from the guidance program
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Other |
Interventions/Control_1
Control group: none
Interventions/Control_2
Intervention group: Dietary guidance and vegetable beverage provision using two biological indicators of 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Intervention group: Employees at TOYOTA MOTOR CORPORATION's at the Teiho plant and Tokyo head office who provide written informed consent to participate in the study.
Control group: Candidate participants not included in the intervention group for whom the study information was publicly disclosed in an explanatory document and who did not express an intention to decline participation (opt-out).
Key exclusion criteria
Control group: None.
Intervention group: 1) Persons with food allergies to the test foods, 2) Persons with potassium intake restrictions, 3) Any other person who is deemed inappropriate by the principal investigator
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Shigenori |
| Middle name | |
| Last name | Suzuki |
Organization
KAGOME CO., LTD.
Division name
Diet & Well-being Research Institute
Zip code
329-2762
Address
17, Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287-36-2935
Shigenori_Suzuki@kagome.co.jp
Public contact
Name of contact person
| 1st name | Haruka |
| Middle name | |
| Last name | Yoshida |
Organization
KAGOME CO., LTD.
Division name
Diet & Well-being Research Institute
Zip code
329-2756
Address
17, Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287-36-2935
Homepage URL
Haruka_Yosdhia@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
Toyota Motor Corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Toyota Motor Corporation Research Ethics Review Committee
Address
1, Toyota-machi, Toyota-shi, Aichi
Tel
090-6394-4362
ethical-guidelines@mega.tec.toyota.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2024-R14
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
トヨタ自動車株式会社 東京本社（東京）、貞宝工場（愛知）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 08 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2025 | Year | 05 | 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
| 2024 | Year | 10 | Month | 07 | Day |
Last modified on
| 2025 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063735
