UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060379 |
|---|---|
| Receipt number | R000069068 |
| Scientific Title | Effects of calcium alginate on blood sodium concentration -A preliminary study in healthy adult males- |
| Date of disclosure of the study information | 2026/01/18 |
| Last modified on | 2026/01/16 15:49:42 |
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Basic information
Public title
Effects of calcium alginate on blood sodium concentration
-A preliminary study in healthy adult males-
Acronym
Effects of calcium alginate on blood sodium concentration
Scientific Title
Effects of calcium alginate on blood sodium concentration
-A preliminary study in healthy adult males-
Scientific Title:Acronym
Effects of calcium alginate on blood sodium concentration
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the inhibitory effect of calcium alginate on blood sodium elevation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area under the curve of postprandial blood sodium levels over time (AUC).
Maximum postprandial blood sodium levels (Cmax).
Blood sodium levels (C) at each measurement point.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Period I: Salt-loading beverage + placebo
Period II: Salt-loading beverage + Test Substance A
Period III: Salt-loading beverage + Test Substance B
Period IV: Salt-loading beverage only
The intervention sequence will follow the order of Period I, Period II, Period III, and Period IV, with each intervention administered as a single dose.
A washout period of at least one week will be implemented between each period.
Interventions/Control_2
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
| Not applicable |
Gender
Male
Key inclusion criteria
- Male participants who are 18 years of age or older at the time of consent.
- Those who have fully understood the purpose and safety of this study as stated in the "Research Cooperation Consent Explanation Form" and have given their consent.
Key exclusion criteria
- Subjects with suspected glucose metabolism disorders or diabetes (including those currently undergoing diabetes treatment, those with fasting blood glucose levels above 125 mg/dL or below 60 mg/dL, those with an HbA1c level of 6.5% or higher, and those taking medications or supplements that affect glucose metabolism)
- Subjects with or a history of serious illnesses such as high blood pressure, kidney disease, diabetes, liver disease, ischemic heart disease, or digestive system disorders
- Subjects whose BMI at the time of provisional registration falls outside the 95% confidence interval (upper or lower limit) of the BMI distribution for all applicants
- Subjects whose HIV antigen/antibody, HBV, HCV, or syphilis tests at the screening test are positive
- Subjects with obvious abnormalities in hematology or biochemistry tests at the screening test
- Subjects who may develop allergic reactions to study-related foods
- Subjects with excessive alcohol or smoking habits (drinking more than 1 go of sake per day, equivalent to 3 or more times per week, or smoking more than 20 cigarettes per day)
- Subjects deemed unsuitable for this study by the investigator
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Satsuki |
| Middle name | |
| Last name | Kimura |
Organization
General Incorporated Association, Kendai Translational Research Center
Division name
Clinical Research Department
Zip code
3700002
Address
450-1-A Hidaka-machi, Takasaki City, Gunma Prefecture
TEL
0273954316
kimura.ktrc@gmail.com
Public contact
Name of contact person
| 1st name | Satsuki |
| Middle name | |
| Last name | Kimura |
Organization
General Incorporated Association, Kendai Translational Research Center
Division name
Clinical Research Department
Zip code
3700002
Address
450-1-A Hidaka-machi, Takasaki City, Gunma Prefecture
TEL
0273954316
Homepage URL
kimura.ktrc@gmail.com
Sponsor or person
Institute
General Incorporated Association, Kendai Translational Research Center
Institute
Department
Personal name
Funding Source
Organization
General Incorporated Association, Kendai Translational Research Center
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
Takasaki University of Health and Welfare Research Ethics Review Committee
Address
37-1 Nakaorui-cho, Takasaki-shi, Gunma, Japan
Tel
0273521290
kuwabara@takasaki-u.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 | 01 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 08 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 12 | 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 | 01 | Month | 16 | Day |
Last modified on
| 2026 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069068
