UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050876 |
|---|---|
| Receipt number | R000055021 |
| Scientific Title | "Low Na / K ratio diet + milk" Hypertension prevention study by cafeteria feeding intervention |
| Date of disclosure of the study information | 2023/04/19 |
| Last modified on | 2023/04/18 11:23:30 |
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Basic information
Public title
"Low Na / K ratio diet + milk" Hypertension prevention study by cafeteria feeding intervention
Acronym
intervention study of Na/K ratio
Scientific Title
"Low Na / K ratio diet + milk" Hypertension prevention study by cafeteria feeding intervention
Scientific Title:Acronym
ntervention study of Na/K ratio
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By providing seasonings a low Na / K ratio (25% lower in sodium than conventional products and a considerable amount of K salt added) to users at feeding facilities, users To verify if there is a decrease in blood pressure
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Difference in blood pressure between standard diet period and reduced Na/K diet and milk period
Key secondary outcomes
Difference in u1rinary Na/K ratio
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
First intervention group
Low Na / K diet + milk or yoghurt 4 weeks
Standard meal 4 weeks
Interventions/Control_2
Second intervention group
Standard meal 4 weeks
Low Na / K diet + milk or yoghurt 4 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants will be recruited from men and women employees who regularly use the employee cafeteria.
Key exclusion criteria
Based on the results of the health examination ane the questionnaire, we will identify the employees with decreased renal function (chronic kidney disease stage 3B or higher) or those who are restricted from potassium
intake by the doctor.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Okayama |
Organization
Research Institute of Strategy for Prevention
Division name
Department of Strategy Research
Zip code
103-0006
Address
10-14, Tomizawa-cho, Nihonbashi, Chuo-ku, Tokyo
TEL
+81-50-3823-0100
aokayama@jrisp.com
Public contact
Name of contact person
| 1st name | Minori |
| Middle name | |
| Last name | Hatakeyama |
Organization
Research Institute of Strategy for Prevention
Division name
Department of Strategy Research
Zip code
103-0006
Address
10-14, Tomizawa-cho, Nihonbashi, Chuo-ku, Tokyo
TEL
+81-50-3823-0100
Homepage URL
office.kenkoeiyo@gmail.com
Sponsor or person
Institute
Research Institute of Strategy for Prevention
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Institute of Japan Dairy Association J-milk
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Institute of Strategy for Prevention
Address
10-14, Tomizawa-cho, Nihonbashi, Chuo-ku, Tokyo
Tel
+81-50-3823-0100
aokayama@jrisp.com
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
| 2023 | Year | 04 | Month | 19 | 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
173
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
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 18 | Day |
Last modified on
| 2023 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055021
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
