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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000017773
Receipt No. 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

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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
Email 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
Email salt-resalt@gmail.com

Sponsor
Institute Sagami Womens University
Institute
Department

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
Email

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
URL(English) https://upload.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


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