UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063367 |
|---|---|
| Receipt number | R000072535 |
| Scientific Title | Effects of dietary salt content and meal timing on postprandial urinary sodium excretion and glucose fluctuations |
| Date of disclosure of the study information | 2026/10/21 |
| Last modified on | 2026/10/21 16:51:13 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of dietary salt content and meal timing on postprandial urinary sodium excretion and glucose fluctuations
Acronym
Effects of dietary salt content and meal timing on postprandial urinary sodium excretion and glucose fluctuations
Scientific Title
Effects of dietary salt content and meal timing on postprandial urinary sodium excretion and glucose fluctuations
Scientific Title:Acronym
Effects of dietary salt content and meal timing on postprandial urinary sodium excretion and glucose fluctuations
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of dietary salt content and meal timing on postprandial urinary sodium excretion and changes in interstitial glucose levels.
Basic objectives2
Others
Basic objectives -Others
Evaluation of the effects of dietary salt content and meal timing
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Postprandial urinary sodium excretion (time course)
Key secondary outcomes
Time-course changes in urinary potassium, creatinine, chloride, aldosterone and cortisol concentrations, and interstitial glucose levels
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
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
High-salt diet: a high-salt diet is consumed at breakfast, lunch and dinner.
Interventions/Control_2
Low-salt diet: a low-salt diet is consumed at breakfast, lunch and dinner.
Interventions/Control_3
Reduced-salt diet: meals using a salt-reduction product (salt replaced with KCl) are consumed at breakfast, lunch and dinner.
Interventions/Control_4
High-salt, high-fiber diet: a high-salt diet supplemented with dietary fiber is consumed at breakfast, lunch and dinner.
Interventions/Control_5
Interventions/Control_6
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
8
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 Aoi 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
Nagoya Aoi University
Address
3-40 Shioji-cho, Mizuho-ku, Nagoya, Aichi, Japan
Tel
052-852-1111
somu@nagoya-aoi.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
| 2026 | Year | 10 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
15
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
| 2025 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 07 | 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
| 2026 | Year | 10 | Month | 21 | Day |
Last modified on
| 2026 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072535
