UMIN-CTR Clinical Trial

Basic information
Public title	Nutritional survey of Na/K urinary ratio and body water content: dietary intervention of tomato
Acronym	Nutritional survey of Na/K urinary ratio and body water content: dietary intervention of tomato
Scientific Title	Nutritional survey of Na/K urinary ratio and body water content: dietary intervention of tomato
Scientific Title:Acronym	Nutritional survey of Na/K urinary ratio and body water content: dietary intervention of tomato
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	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	time of assessment: the following day of intake end point: -body composition measurement -the measurement of Na/K urinary ratio in 24-hour urine collection
Key secondary outcomes	time of assessment: the previous day of intake end point: -Dietary record -Food Frequency Questionnaire

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
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 three grape tomatoes in their diet on the day 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	160

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@shokei-gakuen.ac.jp

Public contact
Name of contact person	1st name Hirokazu Middle name Last name Toubou
Organization	Sinshu 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-gakuen.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	2020 Year 03 Month 31 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	156
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	2018 Year 03 Month 31 Day
Date of IRB	2018 Year 06 Month 07 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 03 Month 31 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=R000045618