UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040014 |
|---|---|
| Receipt number | R000045618 |
| Scientific Title | Nutritional survey of Na/K urinary ratio and body water content: dietary intervention of tomato |
| Date of disclosure of the study information | 2020/03/31 |
| Last modified on | 2021/05/11 10:35:06 |
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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
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
htoubou@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Life Science, Shokei University, Kumamoto, Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045618
