UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060818 |
|---|---|
| Receipt number | R000068829 |
| Scientific Title | Effects on lowering blood pressure and improving eating behavior for salt reduction by reduced-sodium seasonings |
| Date of disclosure of the study information | 2026/03/07 |
| Last modified on | 2026/03/04 15:43:53 |
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Basic information
Public title
Do reduced-sodium seasonings lower blood pressure in middle-aged population?
Acronym
Do reduced-sodium seasonings lower blood pressure in middle-aged population?
Scientific Title
Effects on lowering blood pressure and improving eating behavior for salt reduction by reduced-sodium seasonings
Scientific Title:Acronym
Effects on lowering blood pressure and improving eating behavior for salt reduction by reduced-sodium seasonings
Region
| Japan |
Condition
Condition
Healthy middle-aged individuals
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of salt substitution on lowering blood pressure by using reduced-sodium seasonings
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood pressure
Key secondary outcomes
Urine sodium concentration (24 hour); Salt intake; Salt concentration in dishes; Health habit
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Intervention: During two months, the participants will substitute normal seasonings with reduced-sodium seasonings, self-monitor blood pressure daily, measure sodium concentration in home-cooked soups and stews.
Interventions/Control_2
Control: The participant will self-monitor their blood pressure daily.
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
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Residents in the survey area
Aged 40-74 years
Japanese
Community-dwelling people without receiving daily cares
Ability to communicate with Japanese language
Key exclusion criteria
Kidney disfunction with potassium regulation
Taking potassium-sparing diuretics or antihypertensive drugs
Daily use of low-sodium seasoning
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Yasuharu |
| Middle name | |
| Last name | Tabara |
Organization
Shizuoka Graduate University of Public Health
Division name
Graduate School of Public Health
Zip code
420-0881
Address
4-27-2, Kita Ando, Aoi-ku, Shizuoka 420-0881, Japan
TEL
054-295-5400
tabara@s-sph.ac.jp
Public contact
Name of contact person
| 1st name | Sayaka |
| Middle name | |
| Last name | Nagao-Sato |
Organization
Shizuoka Graduate University of Public Health
Division name
Graduate School of Public Health
Zip code
420-0881
Address
4-27-2, Kita Ando, Aoi-ku, Shizuoka 420-0881, Japan
TEL
054-295-5400
Homepage URL
sysato@s-sph.ac.jp
Sponsor or person
Institute
Shizuoka Graduate University of Public Health
Institute
Department
Personal name
Funding Source
Organization
Shizuoka Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of the Shizuoka Graduate University of Public Health
Address
4-27-2, Kita Ando, Aoi-ku, Shizuoka 420-0881, Japan
Tel
054-295-5400
kenkyu@s-sph.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 | 03 | Month | 07 | 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
| 2026 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | 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 | 04 | Day |
Last modified on
| 2026 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068829
