UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054540 |
|---|---|
| Receipt number | R000062246 |
| Scientific Title | Study on the change of Na excretion by different time of urine collection and the effect of salt intake on blood pressure while sleeping |
| Date of disclosure of the study information | 2024/06/01 |
| Last modified on | 2025/06/04 08:59:23 |
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Basic information
Public title
Study on the change of Na excretion by different time of urine collection and the effect of salt intake on blood pressure while sleeping
Acronym
Study on the change of Na excretion by different time of urine collection and the effect of salt intake on blood pressure while sleeping
Scientific Title
Study on the change of Na excretion by different time of urine collection and the effect of salt intake on blood pressure while sleeping
Scientific Title:Acronym
Study on the change of Na excretion by different time of urine collection and the effect of salt intake on blood pressure while sleeping
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will investigate the difference in Na excretion according to the time of urine collection after eating and further examine whether there is a relationship with blood pressure while sleeping.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Spot urine sodium (Na) excretion, potassium (K) excretion and creatinine (Cre) excretion. 24-hour urine Na excretion, K excretion and Cre excretion. Preprandial and nocturnal blood pressure.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Low salt diet - breakfast high salt diet
Interventions/Control_2
Breakfast high-salt diet - low-salt diet
Interventions/Control_3
Low salt diet - high salt diet for dinner
Interventions/Control_4
Dinner High-salt diet - Low-salt diet
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
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The subjects will be those who do not have a history of serious liver or renal disease, autoimmune disease, diabetes, dyslipidemia, metabolic syndrome, thyroid disease, or other diseases requiring medical treatment in their medical history and current medical condition, who are not taking dietary supplements, who can understand the study description, and who are able to make a decision.
Key exclusion criteria
No serious liver disease, renal disease, autoimmune disease, diabetes, dyslipidemia, metabolic syndrome, thyroid disease, or other diseases requiring medical treatment in the past or present medical history, and no dietary supplements.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Nakagawa |
| Middle name | |
| Last name | Wao |
Organization
Kobe Gakuin University
Division name
Division of Clinical Nutrition
Zip code
651-2180
Address
518, Arise, Ikawadani-cho, Nishiku, Kobe
TEL
078-974-1551
tsutsuiwao@nutr.kobegakuin.ac.jp
Public contact
Name of contact person
| 1st name | Nakagawa |
| Middle name | |
| Last name | Wao |
Organization
Kobe Gakuin University
Division name
Division of Clinical Nutrition
Zip code
651-2180
Address
518, Arise, Ikawadani-cho, Nishiku, Kobe
TEL
078-974-1551
Homepage URL
tsutsuiwao@nutr.kobegakuin.ac.jp
Sponsor or person
Institute
Kobe Gakuin University
Institute
Department
Personal name
Funding Source
Organization
Kobe Gakuin 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
Kobe Gakuin University
Address
518, Arise, Ikawadani-cho, Nishiku, Kobe
Tel
0789741551
kenkyu@j.kobegakuin.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
| 2024 | Year | 06 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 06 | Month | 01 | Day |
Last modified on
| 2025 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062246
