UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063502 |
|---|---|
| Receipt number | R000072679 |
| Scientific Title | Verification study on the salt offset effect of alginate-containing Chinese noodles |
| Date of disclosure of the study information | 2026/11/02 |
| Last modified on | 2026/11/02 17:38:48 |
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Basic information
Public title
Verification study on the salt offset effect of alginate-containing Chinese noodles
Acronym
Verification study on the salt offset effect of alginate-containing Chinese noodles
Scientific Title
Verification study on the salt offset effect of alginate-containing Chinese noodles
Scientific Title:Acronym
Verification study on the salt offset effect of alginate-containing Chinese noodles
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the salt offset effect of alginate-containing Chinese noodles in adult men and women aged 18 to under 65 years after continuous intake for 3 days.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary sodium
Key secondary outcomes
Urinary potassium, urinary sodium-to-potassium ratio, and questionnaire
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
Ingest 120 g test food (alginate-containing Chinese noodles) once a day with ramen soup at lunch for 3 days
Interventions/Control_2
Ingest 120 g control food (alginate-free Chinese noodles, placebo) once a day with ramen soup at lunch for 3 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 and Female
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
2. Japanese men and women aged 18 years old or more and under 65 years old at the time of obtaining consent
Key exclusion criteria
1. Persons who have chronic illness, receiving medication, have a serious disease history
2. Persons who are allergic to the test food
3. Persons who usually take a large amount of alginate-containing foods
4. Persons who usually take medicine (including natriuretics), functional foods for health uses (specified health foods, functional foods, and functional nutrition foods) that have labeled diuretic effects or may have effect to absorption or excretion of salt
5. Persons who have participated in other studies within 1 month before the start of the study, or those who intend to participate in another study after consenting to this study
6. Persons who were judged as inappropriate by the principal investigator
7. Persons who are breastfeeding, pregnant, or planning or hoping to be pregnant during the study period
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuya |
| Middle name | |
| Last name | Hayashi |
Organization
TOYMEDICAL Ltd.
Division name
Research and Development Division
Zip code
861-4151
Address
48-1 Shishimizu, Tomiai-machi, Minami-ku, Kumamoto-shi, Kumamoto, Japan
TEL
096-342-6477
hayashi@toymedical.jp
Public contact
Name of contact person
| 1st name | Genki |
| Middle name | |
| Last name | Yamaguchi |
Organization
TOYMEDICAL Ltd.
Division name
Management Division
Zip code
861-4151
Address
48-1 Shishimizu, Tomiai-machi, Minami-ku, Kumamoto-shi, Kumamoto, Japan
TEL
096-342-6477
Homepage URL
yamaguchi@toymedical.jp
Sponsor or person
Institute
TOYMEDICAL Ltd.
Institute
Department
Personal name
Yuya Hayashi
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 | 23 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 09 | 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=R000072679
