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 | 2023/01/12 14:44:26 |
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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
The Head Office for Regional Collaboration and Innovation
Zip code
693-8501
Address
89-1, Enya-Cho, Izumo City, Shimane Prefecture
TEL
0853-20-2916
nkmr0515@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Mayumi |
| Middle name | |
| Last name | Tsubaki |
Organization
Shimane University
Division name
Clinical Research Center
Zip code
693-8501
Address
89-1, Enya-Cho, Izumo City, Shimane Prefecture
TEL
0853-20-2515
Homepage URL
https://rinken.shimane-u-tiken.jp/ec/ecoutline
kenkyu@med.shimane-u.ac.jp
Sponsor or person
Institute
The Head Office for Regional Collaboration and Innovation,
Shimane University
Institute
Department
Personal name
Funding Source
Organization
The Head Office for Regional Collaboration and Innovation,
Shimane University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
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
| 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
| 2023 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056486
