UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017773 |
|---|---|
| Receipt number | R000020589 |
| Scientific Title | Effect of using low sodium seasonings(miso and soy sauce) or monitoring salt concentration of dishes prepared at home on the reduction of sodium intake among healthy adult Japanese : A randomize control trial |
| Date of disclosure of the study information | 2015/06/03 |
| Last modified on | 2017/03/01 14:47:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of using low sodium seasonings(miso and soy sauce) or monitoring salt concentration of dishes prepared at home on the reduction of sodium intake among healthy adult Japanese : A randomize control trial
Acronym
Intervention study for the salt reduction method development for Japanese
Scientific Title
Effect of using low sodium seasonings(miso and soy sauce) or monitoring salt concentration of dishes prepared at home on the reduction of sodium intake among healthy adult Japanese : A randomize control trial
Scientific Title:Acronym
Intervention study for the salt reduction method development for Japanese
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Salt intake of the Japanese people is largely affected by the use of seasoning.
On the other hand it is difficult to objectively grasp the amount of salt intake, it is a difficult behavioral change of diet.
In a pilot study, the possibility of salt reduction effect by monitoring salt concentration of dishes prepared at home has been suggested.
Therefore, a quantitatively verified study of larger selection of the Japanese population to verify the long-term effectiveness of reproducible salt reduction education is being planned.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of change in 24-hour urinary sodium exertion
Key secondary outcomes
Changes in taste preference and salt-related behaviors on the basis of self-reported data.
Change in body weight.
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
Monitoring the salt concentration of dishes prepared at home along with providing a common informational supplement on salt reduction as the intervention versus providing the same common informational supplement only as the control.
Interventions/Control_2
Provision of low sodium seasonings (miso and soy sauce) as the intervention versus the provision of common sodium seasonings as the control.
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
| Not applicable |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy volunteer
Key exclusion criteria
Current use of hypertensive medicine
Presence of soy allergy
Target sample size
198
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junko Ishihara |
Organization
Sagami Womens University
Division name
Nutrition Science
Zip code
Address
2-1-1,Bunkyo,Minami-ku,Sagamihara-city,Kanagawa,Japan
TEL
+81-42-742-1932
j3ishiha@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Misako Nakadate |
Organization
Sagami Womens University
Division name
Nutrition Science
Zip code
Address
2-1-1,Bunkyo,Minami-ku,Sagamihara-city,Kanagawa,Japan
TEL
+81-42-742-1932
Homepage URL
salt-resalt@gmail.com
Sponsor or person
Institute
Sagami Womens University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
藤沢市役所（神奈川県）
町田市役所（東京都）
相模女子大学（神奈川県）
ならコープ（奈良県）
郡山保健所（奈良県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 03 | 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
| 2015 | Year | 05 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 02 | Day |
Last modified on
| 2017 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020589
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
