UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055569 |
|---|---|
| Receipt number | R000063501 |
| Scientific Title | Effects of dietary environment on stress conditions and taste sensitivity. |
| Date of disclosure of the study information | 2024/09/30 |
| Last modified on | 2025/04/17 16:50:13 |
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Basic information
Public title
Effects of dietary environment on stress conditions and taste sensitivity.
Acronym
Effects of dietary environment on stress and taste sensitivity.
Scientific Title
Effects of dietary environment on stress conditions and taste sensitivity.
Scientific Title:Acronym
Effects of dietary environment on stress and taste sensitivity.
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To know whether alteration of stress conditions in different dietary environment affects taste sensitivity.
Basic objectives2
Others
Basic objectives -Others
Physiological response
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Taste sensitivity
Key secondary outcomes
Blood pressure, pulse rate, and salivary amylase activity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants are asked to spend 5 minutes in each of three different environments (normal, relaxed, and tense).
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
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults who are expected to be able to distinguish five fundamental tastes.
Key exclusion criteria
Persons who are suspected to have taste disorders.
Persons who are allergic to test foods.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Kamiyama |
Organization
Faculty of Human Life Studies, University of Niigata Prefecture
Division name
Department of Health and Nutrition
Zip code
950-8680
Address
471 Ebigase, Higashi-ku, Niigata City, Niigata Prefecture, Japan
TEL
025-368-8269
kammy@unii.ac.jp
Public contact
Name of contact person
| 1st name | Shin |
| Middle name | |
| Last name | Kamiyama |
Organization
Faculty of Human Life Studies, University of Niigata Prefecture
Division name
Department of Health and Nutrition
Zip code
950-8680
Address
471 Ebigase, Higashi-ku, Niigata City, Niigata Prefecture, Japan
TEL
025-368-8269
Homepage URL
kammy@unii.ac.jp
Sponsor or person
Institute
University of Niigata Prefecture
Institute
Department
Personal name
Funding Source
Organization
University of Niigata Prefecture
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Niigata Prefecture
Address
471 Ebigase, Higashi-ku, Niigata City, Niigata Prefecture, Japan
Tel
025-270-1300
unp@unii.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
| 2024 | Year | 09 | 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
13
Results
This study showed that taste perception varied depending on the eating environment. However, although there was a correlation between stress ratings by bio-indicators and taste perception, there was no correlation between stress ratings as a sensation by VAS and taste perception, indicating that changes in taste perception are not related to stress.
Results date posted
| 2025 | Year | 04 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
13 female students (aged 20-22) at University of Niigata Prefecture were participated with consent.
Participant flow
All participants with consent were subjected for analysis.
Adverse events
No adverse events were observed.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2024 | Year | 08 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 01 | 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
| 2024 | Year | 09 | Month | 20 | Day |
Last modified on
| 2025 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063501
