UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026495 |
|---|---|
| Receipt number | R000030431 |
| Scientific Title | The effect of low salt diet with tomato on urinary sodium/potassium balance. |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2018/07/12 09:20:57 |
* 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
The effect of low salt diet with tomato on urinary sodium/potassium balance.
Acronym
The effect of low salt diet with tomato on urinary sodium/potassium balance.
Scientific Title
The effect of low salt diet with tomato on urinary sodium/potassium balance.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Satoshi Sunabori |
Organization
Kagome Co.Ltd.
Division name
Innovation division, Nature&Wellness research department
Zip code
Address
Nishitomiyama 17, Nasushiobara city, Tochigi prefecture
TEL
0287-36-2935
Satoshi_sunabori@kagome.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Hayashi |
Organization
Kagome Co.Ltd.
Division name
Innovation division, Nature&Wellness research department
Zip code
Address
Nishitomiyama 17, Nasushiobara city, Tochigi prefecture
TEL
0287-36-2935
Homepage URL
Hiroki_hayashi@kagome.co.jp
Sponsor or person
Institute
Kagome Co.Ltd.
Institute
Department
Personal name
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)
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
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 |
Related information
URL releasing protocol
Publication of results
Published
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
| 2017 | Year | 03 | Month | 08 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030431
