UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060237 |
|---|---|
| Receipt number | R000068896 |
| Scientific Title | Exploratory study on the acceptability and sodium excretion effect of alginate-containing bread |
| Date of disclosure of the study information | 2025/12/30 |
| Last modified on | 2025/12/30 14:11:17 |
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Basic information
Public title
Investigation of the taste and sodium excretion effect of alginate-containing bread
Acronym
Alginate Bread Study
Scientific Title
Exploratory study on the acceptability and sodium excretion effect of alginate-containing bread
Scientific Title:Acronym
Alginate Bread Study
Region
| Japan |
Condition
Condition
Healthy adults, prevention of lifestyle-related diseases (prevention of hypertension)
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the usefulness of alginate-containing bread in terms of "taste acceptability" and "physiological effects." The first trial evaluates taste, and the second trial exploratorily evaluates the effect on urinary sodium excretion after 5 days of continuous intake.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Taste acceptability (proportion of "delicious" responses or average score on a 5-point scale)
2. Change in urinary salt (sodium) score (Day 5 value - Day 0 value)
Key secondary outcomes
Subjective evaluation of texture, aroma, and appearance; change in moisture score; safety evaluation (presence of gastrointestinal symptoms); and changes in physical sensation (edema, bowel movements, etc.) via questionnaire.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Continuous intake of alginate-containing bread (one piece) once a day for 5 days.
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 and Female
Key inclusion criteria
1. Employees working at the collaborating institution or the institution providing the research field
2. Individuals who understood the purpose of the study and expressed consent to participate by signing
Key exclusion criteria
Individuals with allergies to ingredients (wheat, milk, egg, seaweed, etc.)
Individuals undergoing treatment for kidney disease or receiving potassium restriction guidance from a physician
Pregnant or breastfeeding individuals
Others judged inappropriate by the principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Genki |
| Middle name | |
| Last name | Yamaguchi |
Organization
Toy Medical Co., Ltd.
Division name
Product Division
Zip code
861-4163
Address
48-1 Shishimizu, Tomiai-machi, Minami-ku, Kumamoto-shi, Kumamoto
TEL
096-342-6477
yamaguchi@toymedical.jp
Public contact
Name of contact person
| 1st name | Genki |
| Middle name | |
| Last name | Yamaguchi |
Organization
Toy Medical Co., Ltd.
Division name
Product Division
Zip code
861-4163
Address
48-1 Shishimizu, Tomiai-machi, Minami-ku, Kumamoto-shi, Kumamoto
TEL
096-342-6477
Homepage URL
yamaguchi@toymedical.jp
Sponsor or person
Institute
Toy Medical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kumamoto Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yuurea Inc.
Address
Nagono Campus, 2-14-1 Nagono, Nishi-ku, Nagoya-shi, Aichi
Tel
050-3717-0358
ushijima.takuto@yuurea.co.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
| 2025 | Year | 12 | Month | 30 | 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
| 2025 | Year | 12 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 30 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 19 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 12 | Month | 30 | Day |
Last modified on
| 2025 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068896
