UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057994 |
|---|---|
| Receipt number | R000066283 |
| Scientific Title | A study to evaluate the effects of food ingredients on taste sensitivity |
| Date of disclosure of the study information | 2025/05/29 |
| Last modified on | 2025/12/09 16:56:30 |
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Basic information
Public title
A study to evaluate the effects of food ingredients on taste sensitivity
Acronym
A study to evaluate the effects of food ingredients on taste sensitivity
Scientific Title
A study to evaluate the effects of food ingredients on taste sensitivity
Scientific Title:Acronym
A study to evaluate the effects of food ingredients on taste sensitivity
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effects of food ingredients on taste sensitivity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Taste evaluation after 4 weeks of intervention
Key secondary outcomes
Taste evaluation using VAS (Visual Analog Scale)
Amount of tongue coating
Salivary secretion volume during masticatory stimulation
Blood pressure
Questionnaire on taste and oral condition
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Hold a solution containing food ingredients in the mouth twice a day, for 3 minutes each time, every day for 4 weeks.
Interventions/Control_2
Hold a placebo solution in the mouth twice a day, for 3 minutes each time, every day for 4 weeks.
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
| 25 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Males and females aged 25 to 64 years old
2.People who cannot recognize any of the second lowest concentrations in the taste test
3.People who have given informed consent to participate in the study of their own free will
Key exclusion criteria
1.People diagnosed with or having a history of taste disorders
2.People who regularly use medications that can cause taste disorders or have taken them from two weeks before the test until the start of the test
3.People who regularly take medicines, supplements, or foods containing zinc that may improve taste, or have taken them from two weeks before the test until the start of the test
4.People who are currently smoking
5.People diagnosed with Sjogren's syndrome or dry mouth
6.People diagnosed with or having a history of Sjogren's syndrome or dry mouth
7.People with cerebral infarction, chronic ear infections, chronic runny nose, sinusitis, history of stomach surgery, chronic kidney disease, diabetes, or cancer
8.People receiving radiation therapy
9.People who are pregnant or might be pregnant
10.People with tongue problems or chronic tongue pain
11.People who cannot consume sucrose (sweet), sodium chloride (salty), citric acid (sour), or quinine (bitter) at all
12.People allergic to the test food ingredients or who get itchy or rashes from products with these ingredients
13.People allergic to quinine or who get itchy or rashes from foods with quinine
14.People who have had allergic reactions (including skin itchiness or rashes) or other issues from using dental products like toothpaste or mouthwash, or cosmetics
15.People who are sensitive or allergic to alcohol (like getting itchy or rashes)
16.People with tooth loss other than wisdom teeth, except when due to past orthodontic treatment or accidental injury
17.People wearing braces or other orthodontic devices
18.People with tongue piercings or tattoos
19.People with strict diets that favor or avoid certain foods (like Halal, vegan)
20.People taking part or planning to take part in other oral health or function studies
21.People considered unsuitable by the main researcher
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Kurita |
Organization
Lion corporation
Division name
Advanced oral health science research laboratories
Zip code
132-0035
Address
7-2-1 Hirai, Edogawa-ku, Tokyo, Japan
TEL
03-3616-3796
kei-k@lion.co.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Kurita |
Organization
Lion corporation
Division name
Advanced oral health science research laboratories
Zip code
132-0035
Address
7-2-1 Hirai, Edogawa-ku, Tokyo, Japan
TEL
03-3616-3796
Homepage URL
kei-k@lion.co.jp
Sponsor or person
Institute
LION corporation
Institute
Department
Personal name
Funding Source
Organization
LION corporation
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
Institutional Review Board of Lion corporation
Address
1-3-28, Kuramae, Taito-ku, Tokyo, Japan
Tel
03-6739-3711
tohki@lion.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 | 05 | Month | 29 | 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
31
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 30 | 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 | 05 | Month | 28 | Day |
Last modified on
| 2025 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066283
