UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058304 |
|---|---|
| Receipt number | R000066655 |
| Scientific Title | Evaluation of the Effects of Providing Information and Improving the Environment Related to 'NatKali (Sodium-to-Potassium)' on the Urinary Sodium-to-Potassium Ratio and Vegetable Intake |
| Date of disclosure of the study information | 2025/06/27 |
| Last modified on | 2025/06/27 18:34:35 |
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Basic information
Public title
Evaluation of the Effects of Providing Information and Improving the Environment Related to 'NatKali (Sodium-to-Potassium)' on the Urinary Sodium-to-Potassium Ratio and Vegetable Intake
Acronym
Evaluation of the Effects of Providing Information and Improving the Environment Related to 'NatKali (Sodium-to-Potassium)' on the Urinary Sodium-to-Potassium Ratio and Vegetable Intake
Scientific Title
Evaluation of the Effects of Providing Information and Improving the Environment Related to 'NatKali (Sodium-to-Potassium)' on the Urinary Sodium-to-Potassium Ratio and Vegetable Intake
Scientific Title:Acronym
Evaluation of the Effects of Providing Information and Improving the Environment Related to 'NatKali (Sodium-to-Potassium)' on the Urinary Sodium-to-Potassium Ratio and Vegetable Intake
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessing the impact of information provision and dietary environment support related to 'NatKali (Sodium-to-Potassium)' on changes in urinary sodium-to-potassium ratio and vegetable consumption
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary sodium-to-potassium ratio, Estimated level of vegetable intake, Estimated amount of vegetable intake
Key secondary outcomes
Blood pressure, Stage of behavioral change, Estimated amount of food intake, Estimated amount of nutrient intake, Salt intake level, Potassium intake level
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Other |
Interventions/Control_1
Providing information about 'NatKali (Sodium-to-Potassium).'
Interventions/Control_2
Providing information about 'NatKali (Sodium-to-Potassium).'
Providing an environment that facilitates vegetable intake (Distribution of vegetable beverages).
Interventions/Control_3
No intervention
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
Individuals affiliated with JA Group Kumamoto
Key exclusion criteria
Individuals with chronic kidney disease or a history of such conditions.
Individuals taking medication for diabetes or disorders related to glucose metabolism.
Individuals taking medication for blood pressure treatment.
Individuals with food allergies to the test food.
Individuals receiving dietary guidance regarding potassium from a physician, registered dietitian, or similar professional.
Individuals who are pregnant, breastfeeding, or planning to be during the study period.
Individuals deemed unsuitable as study participants based on the results of a medical interview.
Individuals participating in another human study at the start of this trial.
Any other individuals deemed unsuitable by the principal investigator or the study physician.
Target sample size
390
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 | Takuro |
| Middle name | |
| Last name | Inoue |
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
Homepage URL
Takuro_Inoue@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
Profit organization
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 Nihonbashi Hamacho, Chuo-ku, Tokyo Nihonbashi Hamacho F Tower
Tel
03-5623-8501
IRB@kagome.co.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
| 2025 | Year | 06 | Month | 27 | 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
| 2025 | Year | 06 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 06 | 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
| 2025 | Year | 06 | Month | 27 | Day |
Last modified on
| 2025 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066655
