UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061064 |
|---|---|
| Receipt number | R000069874 |
| Scientific Title | Effect of a lower-sodium, potassium-enriched salt substitute on the urinary Na/K ratio in healthy young adults |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/03/26 13:24:31 |
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Basic information
Public title
Does a salt substitute seasoning reduce the urinary Na/K ratio in healthy young adults ?
Acronym
Does a salt substitute reduce the urinary Na/K ratio?
Scientific Title
Effect of a lower-sodium, potassium-enriched salt substitute on the urinary Na/K ratio in healthy young adults
Scientific Title:Acronym
Effect of a salt substitute (NaCl/KCl) on the urinary Na/K ratio
Region
| Japan |
Condition
Condition
Excess sodium intake and low potassium intake (risk factors for hypertension and cardiovascular diseases)
Classification by specialty
| Medicine in general | Cardiology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility and effect of a potassium-enriched salt substitute seasoning on urinary sodium-to-potassium ratio in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in urinary sodium-to-potassium (Na/K) ratio (mol/mol) between pre-intervention and post-intervention periods, assessed using repeated samples.
Key secondary outcomes
Estimated 24-hour sodium and potassium excretion (Kawasaki Method)
Acceptability and palatability of the seasoning (questionnaire)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Participants will consume a potassium-enriched salt substitute (NaCl/KCl) furikake seasoning (2.0 g per dose, twice daily, total 4 g/day) for 10 consecutive days. The salt substitute contains approximately 50% potassium chloride and 50% sodium chloride.
Participants will be instructed to use the seasoning with meals (e.g., with rice or side dishes) .
The second urine before and during the intervention were collected (3-5 times), and analyzed for urinary Na/K ratio.
Interventions/Control_2
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
| 25 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy students of Aichi Gakuin University aged from 18 to 25 years
Key exclusion criteria
History of kidney disease
Current treatment for heart failure or hypertension
Allergy to any components of the seasoning (e.g., sesame, spices)
Use of medications or supplements affecting sodium or potassium balance (e.g., diuretics, potassium supplements)
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Wakako |
| Middle name | |
| Last name | Maruyama |
Organization
Aichi Gakuin University
Division name
Department of Health and Nutritional Sciences, Faculty of Health Sciences
Zip code
470-0195
Address
12 Araike, Iwasaki-cho, Nisshin-shi, Aichi
TEL
81-561-73-1111
maruyama@dpc.agu.ac.jp
Public contact
Name of contact person
| 1st name | Wakako |
| Middle name | |
| Last name | Maruyama |
Organization
Aichi Gakuin University
Division name
Department of Health and Nutritional Sciences, Faculty of Health Sciences
Zip code
470-0195
Address
12 Araike, Iwasaki-cho, Nisshin-shi, Aichi
TEL
81-561-73-1111
Homepage URL
maruyama@dpc.agu.ac.jp
Sponsor or person
Institute
Aichi Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Aichi Gakuin University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Gakuin University
Address
12 Araike, Iwasaki-cho, Nisshin-shi, Aichi
Tel
81-561-73-1111
m-ccc@dpc.agu.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
| 2026 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 26 | Day |
Last modified on
| 2026 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069874
