UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053451 |
|---|---|
| Receipt number | R000060972 |
| Scientific Title | Effects of the salt reduction program on sodium intake-related indicators for healthy adult men and women |
| Date of disclosure of the study information | 2024/01/31 |
| Last modified on | 2024/01/25 20:46:53 |
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Basic information
Public title
Effects of the salt reduction program on sodium intake-related indicators for healthy adult men and women
Acronym
Effects of the salt reduction program on sodium intake-related indicators for healthy adult men and women
Scientific Title
Effects of the salt reduction program on sodium intake-related indicators for healthy adult men and women
Scientific Title:Acronym
Effects of the salt reduction program on sodium intake-related indicators for healthy adult men and women
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the effectiveness of a salt reduction program developed to support spontaneous salt reduction actions by consumers, we evaluate the impact on urinary indicators related to salt intake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Estimated salt intake and urinary Na/K ratio at 2 and 4 weeks after the start of intervention.
Key secondary outcomes
Blood pressure
Estimated potassium intake
Body weight
Body fat percentage
Questionnaire (Image of salt reduction, food consciousness, eating habits, etc.)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
The intervention group will implement the salt reduction program for 4 weeks.
Interventions/Control_2
The control group will not implement the salt reduction program.
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
1) Men and women who are adults at the time of consent acquisition
2) Those who are not currently practicing salt reduction, but are interested in it
3) Those who are the cook themselves, or those who live with the cook
4) Those who can submit urine samples during the trial period
5) Those who have fully understood the study participation and have obtained written consent by their own free will
Key exclusion criteria
1) Those who are taking antihypertensive drugs for hypertension, or who have been recommended by a doctor to take them
2) Those who have kidney disease
3) Those who have other chronic diseases (such as diabetes, dyslipidemia, etc.) and are undergoing treatment
4) Those who, aside from the above, the study leader/physician in charge deems inappropriate as subjects of this study
Target sample size
124
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Okabe |
Organization
AJINOMOTO CO., INC.
Division name
Institute of Food Sciences and Technologies
Zip code
210-8681
Address
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Japan
TEL
07040179653
yuki.okabe.z4s@asv.ajinomoto.com
Public contact
Name of contact person
| 1st name | Ippei |
| Middle name | |
| Last name | Kawanishi |
Organization
AJINOMOTO CO., INC.
Division name
Institute of Food Sciences and Technologies
Zip code
210-8681
Address
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Japan
TEL
08077388333
Homepage URL
ippei.kawanishi.nd8@asv.ajinomoto.com
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
AJINOMOTO CO., INC.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
AJINOMOTO CO., INC. Committee for the Examination of Trials Involving Humans
Address
1-15-1, Kyobashi, Chuo-ku, Tokyo, Japan
Tel
03-5250-8111
ajinomoto_irb@ajinomoto.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
| 2024 | Year | 01 | Month | 31 | 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
124
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2024 | 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
| 2024 | Year | 01 | Month | 26 | Day |
Last modified on
| 2024 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060972
