UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of low salt diet with tomato on urinary sodium/potassium balance.
Title of the study (Brief title)	The effect of low salt diet with tomato on urinary sodium/potassium balance.
Region	Japan

Condition
Condition	Hypertension
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Understand the effect to low salt diet with tomato on urinary sodium/potassium balance.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Urinary sodium concentration, Urinary potassium concentration, Urinary sodium/potassium ratio.
Key secondary outcomes	Systolic blood pressure, Diastolic blood pressure, Urinary creatinine concentration, questionnaire.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Subjects eat test-meal for 2weeks. The test-meal 1week-set repeats 2 times contain 21 menu (3meals/day times 7days). Nutritional property of the meal is designed for 1,800-2,000kcal energy, 8.0-9.0g salt, over 2,000mg potassium/ day. During the test, subjects can eat only test-meal and drink which not contain sugar or sodium (e.g. water or tea), must not eat other foods and drinks .
Interventions/Control_2	Subjects eat test-meal for 2weeks. The test-meal 1week-set repeats 2 times contain 21 menu (3meals/day times 7days). Nutritional property of the meal is designed for 1,800-2,000kcal energy, 6.0-7.0g salt, over 2,000mg potassium/ day. Some menus are modified to low salt, and for minimize the difference of taste, replace a portion of seasoning with tomato, tomato ketchup and tomato sauce. During the test, subjects can eat only test-meal and drink which not contain sugar or sodium (e.g. water or tea), must not eat other foods and drinks.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy adults over 20 years-old
Key exclusion criteria	1.Who takes medicine for hypertension, or medicines contain sodium/potassium. 2.Who has food allergy to test-meal. 3.Who plans pregnancy or breast-feeding. 4.Who joins other human study. 5.Who is judged unsuitable for this study by principal investigator.
Target sample size	40

Research contact person
Name of lead principal investigator	Satoshi Sunabori
Organization	Kagome Co.Ltd.
Division name	Innovation division, Nature&Wellness research department
Address	Nishitomiyama 17, Nasushiobara city, Tochigi prefecture
TEL	0287-36-2935
Email	Satoshi_sunabori@kagome.co.jp

Public contact
Name of contact person	Hiroki Hayashi
Organization	Kagome Co.Ltd.
Division name	Innovation division, Nature&Wellness research department
Address	Nishitomiyama 17, Nasushiobara city, Tochigi prefecture
TEL	0287-36-2935
Homepage URL
Email	Hiroki_hayashi@kagome.co.jp

Sponsor
Institute	Kagome Co.Ltd.
Institute
Department

Funding Source
Organization	Kagome Co.Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Kagawa Nutrition University
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	女子栄養大学（埼玉県）

Other administrative information
Date of disclosure of the study information	2017 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 08 Day
Anticipated trial start date	2017 Year 03 Month 30 Day
Last follow-up date	2017 Year 04 Month 28 Day
Date of closure to data entry	2017 Year 05 Month 13 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 10 Day
Last modified on	2018 Year 07 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030431