UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Junko Ishihara
Organization	Sagami Womens University
Division name	Nutrition Science
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	Misako Nakadate
Organization	Sagami Womens University
Division name	Nutrition Science
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2015 Year 05 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000020589