UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062023 |
|---|---|
| Receipt number | R000070962 |
| Scientific Title | Exploration of food components and nutrients that affect preferences and sensitivity to saltiness |
| Date of disclosure of the study information | 2026/09/25 |
| Last modified on | 2026/06/23 12:24:16 |
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Basic information
Public title
Sensory Evaluation of the Taste Quality of Food Ingredients
Acronym
Food Components Taste Study
Scientific Title
Exploration of food components and nutrients that affect preferences and sensitivity to saltiness
Scientific Title:Acronym
Food Components Taste Study
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether food components or nutrients alter salt preference and sensitivity in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Preference for and sensitivity to saltiness following ingestion of the target substance
Key secondary outcomes
Individual evaluations and free-form comments regarding overall flavor intensity, sweetness, saltiness, sourness, bitterness, umami, astringency, spiciness, pungency, aftertaste, and other flavor qualities
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The intervention period is 1 day
The number and frequency of interventions are 2-5 samples per day, with approximately 7 interventions during the test period
The amount of food components to use depends on the recommended or typical usage instructions for the product purchased
Allocation is randomized or balanced
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
| 40 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Gender: Male/Female
Age:20-40
Key exclusion criteria
1) Individuals with allergies, hypersensitivity, or intolerance to the test food or any of its ingredients.
2) Individuals with taste disorders, smell disorders, severe oral diseases, oral mucosal diseases, or oral pain.
3) Individuals experiencing cold symptoms, fever, nasal congestion, cough, or general malaise on the day of the test.
4) Individuals taking medications that may affect taste or saliva secretion.
5) Individuals who are pregnant or breastfeeding.
6) Individuals who have eaten, drunk, smoked, used fragrances, brushed their teeth, or used mouthwash within the specified time period (within 2 hours) prior to the trial. However, drinking water is permitted.
7) Individuals whom the principal investigator deems unsuitable for participation in this trial.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Taiki |
| Middle name | |
| Last name | Fushimi |
Organization
Tokushima University
Division name
Graduate School of Biomedical Sciences
Zip code
770-8503
Address
3-18-15, Kuramoto-cho, Tokushima-city, Tokushima, Japan
TEL
088-633-7089
fushimi.taiki@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Taiki |
| Middle name | |
| Last name | Fushimi |
Organization
Tokushima University
Division name
Graduate School of Biomedical Sciences
Zip code
770-8503
Address
3-18-15, Kuramoto-cho, Tokushima-city, Tokushima, Japan
TEL
088-633-7089
Homepage URL
fushimi.taiki@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University
Institute
Department
Personal name
Taiki Fushimi
Funding Source
Organization
Tokushima University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Tokushima University Hospital
Address
2-50-1, Kuramoto-cho, Tokushima-city, Tokushima, Japan
Tel
088-633-9294
awachiken@tokushima-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 | 09 | Month | 25 | 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 | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 25 | Day |
Last follow-up date
| 2028 | 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 | 06 | Month | 23 | Day |
Last modified on
| 2026 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070962
