UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060281 |
|---|---|
| Receipt number | R000068957 |
| Scientific Title | Sensory evaluation of the test sample |
| Date of disclosure of the study information | 2026/01/07 |
| Last modified on | 2026/01/07 14:46:49 |
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Basic information
Public title
Flavor check test
Acronym
FCT
Scientific Title
Sensory evaluation of the test sample
Scientific Title:Acronym
SE-TS
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the sensory characteristics of test samples containing organically synthesized saltiness replacers A and B.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To verify the effectiveness of the saltiness-enhancing effect.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
When the subjects visit the study site, they will consume a single dose of the test product containing Salt Substitute Substance A or B. They will then verbally report their impressions of taste, texture, and other sensory attributes (sensory evaluation), which will be recorded by the study staff.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Male and female subjects aged >=20 years and <80 years at the time of obtaining informed consent.
Subjects who have received a sufficient explanation of the purpose and procedures of this study, have the capacity to provide consent, voluntarily agree to participate after fully understanding the study, and are able to provide written informed consent for participation in this study.
Key exclusion criteria
1) Subjects with a known allergy to the investigational product ingredients (wheat, soybeans, or beef).
2) Pregnant or breastfeeding subjects.
3) Subjects who have difficulty consuming the investigational product due to oral/dental disorders, gastrointestinal disorders, or other reasons.
4) Subjects with a history of, or current, serious disease(s) of the liver, kidney, heart, lung, blood, or other organ/system.
5) Subjects with serious concomitant gastrointestinal disease(s) and/or a history of serious gastrointestinal disease.
6) Subjects with a body mass index (BMI) >= 35 kg/m2.
7) Subjects whose habitual alcohol consumption exceeds 60 g/day in terms of pure alcohol equivalent.
8) Subjects who are continuously taking medications that may affect this study.
9) Subjects who are currently receiving medical treatment for a disease and whose treatment is judged to potentially affect the study results or safety.
10) Subjects deemed inappropriate for participation in this study by the principal investigator for any other reason.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Mitsuru |
| Middle name | |
| Last name | Tanaka |
Organization
Nissin Foods Holdings Co., Ltd.
Division name
Global Food Safety Institute
Zip code
1920001
Address
2100 Tobuki-cho, Hachioji-shi, Tokyo, Japan
TEL
0426967833
takahiro.matsuda@nissin.com
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Matsuda |
Organization
Nissin Foods Holdings Co., Ltd.
Division name
Global Food Safety Institute
Zip code
1920001
Address
2100 Tobuki-cho, Hachioji-shi, Tokyo, Japan
TEL
0426967833
Homepage URL
takahiro.matsuda@nissin.com
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Other
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
Nissin Foods Holdings Co., Ltd.
Address
2100 Tobuki-cho, Hachioji-shi, Tokyo, Japan
Tel
0426967833
takahiro.matsuda@nissin.com
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 | 07 | 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 | 11 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 11 | Month | 19 | 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 | 07 | Day |
Last modified on
| 2026 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068957
