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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044168
Receipt No. R000050437
Scientific Title Nutritional survey of Na/K urinary ratio and body water content: dietary intervention of tomato (Investigation of the effect of long-term intake)
Date of disclosure of the study information 2021/05/12
Last modified on 2021/05/11

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Basic information
Public title Nutritional survey of Na/K urinary ratio and body water content: dietary intervention of tomato (Investigation of the effect of long-term intake)
Acronym Nutritional survey of Na/K urinary ratio and body water content: dietary intervention of tomato (Investigation of the effect of long-term intake)
Scientific Title Nutritional survey of Na/K urinary ratio and body water content: dietary intervention of tomato (Investigation of the effect of long-term intake)
Scientific Title:Acronym Nutritional survey of Na/K urinary ratio and body water content: dietary intervention of tomato (Investigation of the effect of long-term intake)
Region
Japan

Condition
Condition None
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose is to verify that tomato affect Na/K urinary ratio and body water content, we compared between tomato recommended population on dietary intervention and non-intervening population as part of the nutritional survey of Na/K urinary ratio and body water content
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes body composition measurement
the measurement of Na/K urinary ratio in 24-hour urine collection
Key secondary outcomes Dietary record
Food Frequency Questionnaire
Blood pressure measurement

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 The subject who are assigned to the dietary intervention group is received national registered dietitian's dietary intervention, then they include tomatoes in their diet for 10 days before urine collection
Interventions/Control_2 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
18 years-old <=
Age-upper limit
65 years-old >=
Gender Female
Key inclusion criteria (1)Women aged between 20 to 65 years old
(2)Relatively healthy person, especially, no heart disease
(3)Subject who can collect urine for 24 hours
(4)Subjects who received a sufficient explanation of the purpose and contents of this examination, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document.
Key exclusion criteria (1)Subject who could not record diet
(2)Subject who could not collect urine properly
(3)Subjects who are judged as unsuitable for the study by the investigator for other reasons.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Mariko
Middle name
Last name Morita
Organization Shokei University
Division name Department of Life Science
Zip code 862-8678
Address 2-6-78 Kuhonji, Chuo-ku, Kumamoto
TEL 096-362-2011
Email m_morita@syokei-gakuen.ac.jp

Public contact
Name of contact person
1st name Hirokazu
Middle name
Last name Toubou
Organization Shinshu university
Division name school of medicine
Zip code 390-8621
Address 3-1-1 Asahi, Matsumoto, Nagano
TEL 0263-37-2622
Homepage URL
Email htoubou@shinshu-u.ac.jp

Sponsor
Institute Department of Life Science, Shokei University, Kumamoto, Japan
Institute
Department

Funding Source
Organization Department of Life Science, Shokei University, Kumamoto, Japan
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Shokei University
Address 2-6-78 Kuhonji, Chuo-ku, Kumamoto
Tel 096-362-2011
Email sakata@shokei-u.ac.jp

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
2021 Year 05 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 Preinitiation
Date of protocol fixation
2021 Year 03 Month 01 Day
Date of IRB
2021 Year 04 Month 20 Day
Anticipated trial start date
2021 Year 05 Month 12 Day
Last follow-up date
2021 Year 10 Month 01 Day
Date of closure to data entry
2021 Year 12 Month 31 Day
Date trial data considered complete
2022 Year 03 Month 31 Day
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2021 Year 05 Month 11 Day
Last modified on
2021 Year 05 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050437

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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