UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057679 |
|---|---|
| Receipt number | R000065909 |
| Scientific Title | Effectiveness of Digital Tool-Based Feedback on Urinary Sodium-to-Potassium Ratio and Vegetable/Fruit Intake for Hypertension Prevention in Young Adults: A Two-Arm Parallel-Group Randomized Controlled Pilot Trial |
| Date of disclosure of the study information | 2025/04/23 |
| Last modified on | 2025/10/22 10:34:40 |
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Basic information
Public title
Effectiveness of Digital Tool-Based Feedback on Urinary Sodium-to-Potassium Ratio and Vegetable/Fruit Intake for Hypertension Prevention in Young Adults
Acronym
NaK-Care Study
Scientific Title
Effectiveness of Digital Tool-Based Feedback on Urinary Sodium-to-Potassium Ratio and Vegetable/Fruit Intake for Hypertension Prevention in Young Adults: A Two-Arm Parallel-Group Randomized Controlled Pilot Trial
Scientific Title:Acronym
NaK-Care Trial
Region
| Japan |
Condition
Condition
Healthy young adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Pilot study on the effectiveness of immediate digital feedback on urinary sodium-to-potassium ratio and vegetable/fruit intake for hypertension prevention in young adults
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary sodium-to-potassium ratio assessed by 24-hour urine collection
Key secondary outcomes
Vegetable and fruit intake
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants assigned to the intervention group will utilize a portable device to measure their urinary sodium-to-potassium ratio over a four-week period. Additionally, they will receive immediate feedback on their estimated vegetable intake every two weeks. This feedback, delivered through a digital application, aims to support improvements in dietary and lifestyle habits by promoting behavioral changes.
Interventions/Control_2
Participants assigned to the control group will continue their usual lifestyle during the four-week study period without receiving any specific interventions or feedback. After the study concludes, they will be provided with feedback on their measurement data.
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
| 18 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Male and female participants aged between 18 and 30 years.
Individuals not currently diagnosed with hypertension by a physician.
Willingness to participate in the study and comply with study instructions.
Key exclusion criteria
Individuals currently undergoing treatment for hypertension, including antihypertensive medications.
Individuals with severe heart disease, kidney disease, or other chronic illnesses.
Pregnant or breastfeeding women.
Individuals participating in other clinical trials during the study period.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kenichiro |
| Middle name | |
| Last name | Yasutake |
Organization
Nakamura Gakuen University
Division name
Department of Nutritional Sciences
Zip code
814-0198
Address
5-7-1 Befu, Jonan-ku, Fukuoka 814-0198, Japan
TEL
0928515389
yasutake@nakamura-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenichiro |
| Middle name | |
| Last name | Yasutake |
Organization
Nakamura Gakuen University
Division name
Department of Nutritional Sciences
Zip code
814-0198
Address
5-7-1 Befu, Jonan-ku, Fukuoka 814-0198, Japan
TEL
0928512531
Homepage URL
yasutake@nakamura-u.ac.jp
Sponsor or person
Institute
Nakamura Gakuen University
Institute
Department
Personal name
Kenichiro Yasutake
Funding Source
Organization
Nakamura Gakuen University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nakamura Gakuen University
Address
5-7-1 Befu, Jonan-ku, Fukuoka 814-0198, Japan
Tel
0928512531
kks@nakamura-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
| 2025 | Year | 04 | Month | 23 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 23 | Day |
Last follow-up date
| 2030 | Year | 02 | Month | 28 | 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 | 04 | Month | 22 | Day |
Last modified on
| 2025 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065909
