UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012560
Receipt number R000013246
Scientific Title Effect of using low sodium seasonings (miso and soy sauce) or monitoring salt concentration of dishes prepared at home for 12 weeks on the reduction of sodium intake among healthy middle-aged Japanese individuals: A randomized, controlled, crossover trial
Date of disclosure of the study information 2013/12/12
Last modified on 2014/12/12 12:13:40

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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 for 12 weeks on the reduction of sodium intake among healthy middle-aged Japanese individuals: A randomized, controlled, crossover trial

Acronym

Effect of using low sodium seasonings or monitoring salt concentration for 12 weeks on sodium intake reduction: a randomized, controlled, crossover trial

Scientific Title

Effect of using low sodium seasonings (miso and soy sauce) or monitoring salt concentration of dishes prepared at home for 12 weeks on the reduction of sodium intake among healthy middle-aged Japanese individuals: A randomized, controlled, crossover trial

Scientific Title:Acronym

Effect of using low sodium seasonings or monitoring salt concentration for 12 weeks on sodium intake reduction: a randomized, controlled, crossover trial

Region

Japan


Condition

Condition

Healthy middle-aged individuals

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Reducing dietary salt intake remains a challenging issue in the management of chronic disease. Asian populations, including the Japanese, tend to have higher sodium consumption than Western populations. Moreover, the contribution of salty seasonings added during food preparation at home or the table to sodium consumption is relatively high. Thus, dietary sodium reductions can also be achieved by reducing these discretionary components. Therefore, we conducted this trial to examine the feasibility and effect of using low sodium seasonings (miso and soy sauce) and monitoring salt concentration of dishes prepared at home on the reduction of daily sodium intake among middle-aged healthy Japanese individuals.

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 excretion

Key secondary outcomes

Change in taste threshold for saltiness;
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

Cross-over

Randomization

Randomized

Randomization unit


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 information supplement on salt reduction as the intervention versus providing the same common information 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

40 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

Healthy volunteer
* The candidate group included subjects of a prior cross-sectional observational study that was conducted with the purpose of comparing the validity of dietary estimation data using a food frequency questionnaire to that obtained from dietary records.

Key exclusion criteria

Current use of hypertensive medicine and presence of soy allergy

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ribeka TAKACHI

Organization

Niigata University Graduate School of Medical and Dental Sciences

Division name

Division of Social and Environmental Medicine

Zip code


Address

1-757 Asahicho-dori, Chuo-ku, Niigata, 951-8510 Japan.

TEL

+81-25-227-2121

Email

rtakachi@med.niigata-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ribeka TAKACHI

Organization

Niigata University Graduate School of Medical and Dental Sciences

Division name

Division of Social and Environmental Medicine

Zip code


Address

1-757 Asahicho-dori, Chuo-ku, Niigata, 951-8510 Japan.

TEL

+81-25-227-2121

Homepage URL


Email

rtakachi@med.niigata-u.ac.jp


Sponsor or person

Institute

Niigata University Graduate School of Medical and Dental Sciences

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Epidemiology and Prevention Division, Research Center for Cancer Prevention and Screening, National Cancer Center, Tokyo, Japan.

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



Other administrative information

Date of disclosure of the study information

2013 Year 12 Month 12 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

Completed

Date of protocol fixation

2013 Year 12 Month 09 Day

Date of IRB


Anticipated trial start date

2013 Year 12 Month 13 Day

Last follow-up date

2014 Year 08 Month 31 Day

Date of closure to data entry

2014 Year 08 Month 31 Day

Date trial data considered complete

2014 Year 12 Month 31 Day

Date analysis concluded

2015 Year 01 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 12 Month 12 Day

Last modified on

2014 Year 12 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013246


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name