UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063495 |
|---|---|
| Receipt number | R000072672 |
| Scientific Title | Study on the inhibitory effect of salt-offset bread intake on salt absorption |
| Date of disclosure of the study information | 2026/11/02 |
| Last modified on | 2026/11/02 14:13:57 |
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Basic information
Public title
Study on the inhibitory effect of salt-offset bread intake on salt absorption
Acronym
Study on the inhibitory effect of salt-offset bread intake on salt absorption
Scientific Title
Study on the inhibitory effect of salt-offset bread intake on salt absorption
Scientific Title:Acronym
Study on the inhibitory effect of salt-offset bread intake on salt absorption
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the salt absorption inhibitory effect on Japanese adult males (18 to 64 years old) by ingesting alginate-containing bread for 4 consecutive days.
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, urinary creatinine excretion, and urinary sodium-to-potassium ratio.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consume the test food (alginate-containing bread) once a day at lunch for 4 consecutive days (along with prescribed meals for 7 days).
Interventions/Control_2
Consume the placebo food (placebo bread) once a day at lunch for 4 consecutive days (along with prescribed meals for 7 days).
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
Male
Key inclusion criteria
1) Persons who received a sufficient explanation of the purpose and contents of the study, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate in the study.
2) Persons who are Japanese males aged 18 years or older and under 65 years old at the time of obtaining consent.
Key exclusion criteria
1) Persons who have chronic illness, receiving medication, or have a serious disease history
2) Persons who have been diagnosed by a physician with glucose intolerance (type 2 diabetes, impaired glucose tolerance, etc.), dyslipidemia, hypertension, hyperuricemia/gout, coronary artery disease, cerebral infarction/transient ischemic attack, non-alcoholic fatty liver disease, obstructive sleep apnea syndrome/obesity hypoventilation syndrome, locomotor disease (osteoarthritis: knee, hip, finger joints, spondylosis deformans), or obesity-related kidney disease
3) Persons whose BMI is under 20 kg/m2 or 25 kg/m2 or more
4) Persons whose eGFR is under 60 mL/min/1.73m2
5) Persons who are allergic to the test food (bread or alginates) or prescribed diets
6) Persons who usually take a large amount of the test food (alginates)
7) Persons who usually take medicine, functional foods for health uses, etc. that may have an effect on salt absorption or excretion
8) Persons who have participated in other studies within 1 month prior to the start of the study, or who intend to participate in other studies after consenting to this study
9) Persons who are judged as inappropriate for study participants by the study supervising physician and principal investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akiko |
| Middle name | |
| Last name | Okamura |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Park Place Bld. 5F, 5-27-1, Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
okamura@hc-sys.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Okamura |
Organization
Healthcare Systems Co., Ltd.
Division name
Clinical Research Department
Zip code
105-0004
Address
Park Place Bld. 5F, 5-27-1, Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
Homepage URL
okamura@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Akiko Okamura
Funding Source
Organization
TOYMEDICAL Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18, Shirakane, Showa-ku, Nagoya, Aichi, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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 | 11 | Month | 02 | 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 | 10 | Month | 07 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 13 | 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
| 2026 | Year | 11 | Month | 02 | Day |
Last modified on
| 2026 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072672
