UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050566 |
|---|---|
| Receipt number | R000057597 |
| Scientific Title | Effect of vegetable intake time on urinary sodium excretion after high-salt diet |
| Date of disclosure of the study information | 2023/03/13 |
| Last modified on | 2025/04/23 11:21:21 |
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Basic information
Public title
Effect of vegetable intake time on urinary sodium excretion after high-salt diet
Acronym
Effect of vegetable intake time on urinary sodium excretion after high-salt diet
Scientific Title
Effect of vegetable intake time on urinary sodium excretion after high-salt diet
Scientific Title:Acronym
Effect of vegetable intake time on urinary sodium excretion after high-salt diet
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to investigate the intake time of vegetables (foods with high potassium content: vegetables, fruits, and potatoes) that are effective for natriuresis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary sodium excretion
Key secondary outcomes
Urinary potassium excretion
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake vegetables with breakfast
Interventions/Control_2
Intake vegetables with lunch
Interventions/Control_3
Intake vegetables with supper
Interventions/Control_4
Intake vegetables at 10:00 a.m.
Interventions/Control_5
Intake vegetables at 3:00 p.m.
Interventions/Control_6
Not intake vegetables
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 23 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Healthy female university students
2) Subjects who have received a sufficient explanation of the purpose and content of this study, and agreed to participate by signing
Key exclusion criteria
1) Subjects with abnormal blood pressure and renal function
2) Subjects with diseases that require constant medication
3) Subjects with medical history of severe diseases
4) Subjects who are judged as inappropriate by investigators
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Nishida |
Organization
Nagoya Aoi University
Division name
Faculty of Health Sciences Department of Health and Nutrition
Zip code
467-8610
Address
3-40 Shioji-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL
052-852-9422
nishida@nagoya-aoi.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Nishida |
Organization
Nagoya Aoi University
Division name
Faculty of Health Sciences Department of Health and Nutrition
Zip code
467-8610
Address
3-40 Shioji-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL
052-852-9422
Homepage URL
nishida@nagoya-aoi.ac.jp
Sponsor or person
Institute
Nagoya Aoi University
Institute
Department
Personal name
Funding Source
Organization
Nagoya Women's University
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
Ethics Review Committee for Research on Human Subjects in Nagoya Women's University
Address
3-40 Shioji-cho, Mizuho-ku, Nagoya, Aichi, Japan
Tel
052-852-1111
somu@nagoya-aoi.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2022-22
Org. issuing International ID_1
Ethics Review Committee for Research on Human Subjects in Nagoya Women's University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 13 | 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
6
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 15 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 03 | Month | 13 | Day |
Last modified on
| 2025 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057597
