UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049601 |
|---|---|
| Receipt number | R000056486 |
| Scientific Title | Examination of a new system to facilitate salt restriction |
| Date of disclosure of the study information | 2022/11/28 |
| Last modified on | 2025/11/26 14:37:29 |
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Basic information
Public title
Examination of the continuity and usefulness of a low-salt system that allows free selection of recipes
Acronym
Examination of a new salt reduction system
Scientific Title
Examination of a new system to facilitate salt restriction
Scientific Title:Acronym
Examination of salt restriction system
Region
| Japan |
Condition
Condition
high blood pressure
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Utilizing Shimane University's patented technology, we will examine the continuity and usefulness of the "low-salt system" using a menu app, frozen ingredients, and eleven types low-salt retort sauces.
Basic objectives2
Others
Basic objectives -Others
Usefulness
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Completion rate of this salt reduction system 4 weeks after the start of feeding
Key secondary outcomes
Changes in systolic blood pressure 4 weeks after the start of feeding
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Feeding for 4 weeks
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
| 20 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Hypertensive subjects (systolic blood pressure 130 mmHg or higher) who do not take antihypertensive drugs.
Key exclusion criteria
1) Hypertensive subjects not taking antihypertensive drugs (systolic blood pressure 180 mmHg or higher)
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Morihiko |
| Middle name | |
| Last name | Nakamura |
Organization
Shimane University
Division name
Faculty of Medicine
Zip code
693-8501
Address
89-1, Enya-Cho, Izumo City, Shimane Prefecture
TEL
0853-20-2377
nkmr0515@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Morihiko |
| Middle name | |
| Last name | Nakamura |
Organization
Shimane University
Division name
Faculty of Medicine
Zip code
693-8501
Address
89-1, Enya-Cho, Izumo City, Shimane Prefecture
TEL
0853-20-2377
Homepage URL
nkmr0515@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
Shimane 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
Shimane University
Address
89-1, Enya-Cho, Shimane Prefecture
Tel
0853-20-2515
kenkyu@med.shimane-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
| 2022 | Year | 11 | Month | 28 | Day |
Related information
URL releasing protocol
https://ir.lib.shimane-u.ac.jp/55380
Publication of results
Published
Result
URL related to results and publications
https://ir.lib.shimane-u.ac.jp/55380
Number of participants that the trial has enrolled
10
Results
A 28-day trial involving 10 hypertensive patients not receiving antihypertensive therapy demonstrated high adherence and completion rate. Following the intervention, mean systolic blood pressure decreased, and urinary sodium excretion also declined. This suggests the usefulness of the "Infinite Recipes" system.
Results date posted
| 2025 | Year | 11 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 09 | Month | 15 | Day |
Baseline Characteristics
This study enrolled 10 Izumo City Hall, Shimane, Japan, employees who agreed to participate in the research. The eligibility criteria were as follows:hypertensives (SBP greater than 130 mmHg and less than 180 mmHg) who were not administered with antihypertensive treatment. On the other hand, patients on hemodialysis or peritoneal dialysis with potassium restriction were excluded from the study.
Participant flow
The 10 subjects were not concentrated in a particulardepartment ,but were assigned to different departments.In accordance with the study design, these 10 subjects learned the correct blood pressure measurementmethod via video, took blood pressurereadings at home every morning and evening forthree weeks using the same sphygmomanometer, andentered those blood pressure levels into the application.The subjects measured their blood pressuretwice, entered the measurements into the application,and the average value was automatically recorded.After three weeks (observation period prior to interventionstudy), we observed that there was lessvariation in each of the measurements in all of thesubjects. From this information, the principal investigatorconfirmed that all of them met the eligibilitycriteria (130-180 mmHg). The planned number ofcases for this study was 10, so the study was performed.Height and weight were measured at thebeginning of the study.
Adverse events
None
Outcome measures
Sustainability of Low-Salt Diet (28 Days)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 11 | Month | 24 | Day |
Last modified on
| 2025 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056486
