UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056934 |
|---|---|
| Receipt number | R000065065 |
| Scientific Title | Efficacy of Dietary Intervention Approaches to Prevent Hypertension in Local Residents |
| Date of disclosure of the study information | 2025/02/04 |
| Last modified on | 2025/02/04 22:54:15 |
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Basic information
Public title
Efficacy of Dietary Intervention Approaches to Prevent Hypertension in Local Residents
Acronym
Efficacy of Dietary Intervention Approaches to Prevent Hypertension in Local Residents
Scientific Title
Efficacy of Dietary Intervention Approaches to Prevent Hypertension in Local Residents
Scientific Title:Acronym
Efficacy of Dietary Intervention Approaches to Prevent Hypertension in Local Residents
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify approaches to promote dietary behaviors that lead to the prevention of hypertension in local residents.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary sodium-to-potassium ratio
Key secondary outcomes
Gut Microbiome Industry, Lifestyle, Stress Status and Behavior Change Stage in Health interests.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Optimal Salt Diet 4weeks
Interventions/Control_2
Optimal Salt Diet 4weeks+Nudge+Incentives
Interventions/Control_3
Optimal Salt Diet 4weeks+Disclose Na/K ratio in advance
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The participants will be recruited from employees of the cooperating companies.
Persons who have given their consent to participate in the research.
Key exclusion criteria
Persons who are allergic to the target foods, have severe hepatic or renal dysfunction, have severe diabetes mellitus, or have a tendency toward severe obesity.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Sayuri |
| Middle name | |
| Last name | Goryoda |
Organization
Yamagata University
Division name
Faculty of Agriculture
Zip code
997-0037
Address
1-23 Wakaba-cho, Tsuruoka-shi, Yamagata 997-0037
TEL
0235282859
goryoda@tds1.tr.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | Sayuri |
| Middle name | |
| Last name | Goryoda |
Organization
Yamagata University
Division name
Faculty of Agriculture
Zip code
997-0037
Address
1-23 Wakaba-cho, Tsuruoka-shi, Yamagata 997-0037
TEL
0235282859
Homepage URL
goryoda@tds1.tr.yamagata-u.ac.jp
Sponsor or person
Institute
Yamagata University
Institute
Department
Personal name
Funding Source
Organization
Yamagata 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
The Ethical Review Committee of Yamagata University Faculty of Medicine
Address
2-2-2 Iida-nishi, Yamagata city, Yamagata
Tel
023-628-5047
yu-ikekenkyu@jm.kj.yamagata-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
| 2025 | Year | 02 | Month | 04 | 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
| 2024 | Year | 10 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 04 | 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
| 2025 | Year | 02 | Month | 04 | Day |
Last modified on
| 2025 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065065
