UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048812 |
|---|---|
| Receipt number | R000055622 |
| Scientific Title | Investigation of cross-modal phenomenon of vision and taste by latent association test (IAT) - Relationship between vessel shape and taste |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2024/03/29 14:01:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation by latent association test for the influence of vision on taste
Acronym
Evaluation by latent association test for the influence of vision on taste
Scientific Title
Investigation of cross-modal phenomenon of vision and taste by latent association test (IAT) - Relationship between vessel shape and taste
Scientific Title:Acronym
Investigation of cross-modal phenomenon of vision and taste by latent association test (IAT) - Relationship between vessel shape and taste
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify that the cross-modal phenomenon of visual and gustatory perception is due to latent rather than manifest attitudes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Evaluate validity using IAT d-scores
Key secondary outcomes
Visual Analogue Scale (VAS)
Assumption of selling price
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
IAT -> eat jellies in containers with square rims -> (1 minute break) -> eat jellies in containers with round rims
Interventions/Control_2
IAT -> eat jellies in containers with rounded rims -> (1 minute break) -> eat jellies in containers with square rims
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
| 22 | years-old | >= |
Gender
Female
Key inclusion criteria
We recruited female students in the first through third years of the Department of Health and Nutrition at Niigata University of Health and Welfare, and selected healthy female university students who agreed with the study content and decided to participate of their own free will.
Key exclusion criteria
If there is a complaint of malfunction at the time of the experiment
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Haruki |
| Middle name | |
| Last name | Ishikawa |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Nutrition
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku niigata-shi, Niigata, JAPAN
TEL
0252574413
harumaki.busi@gmail.com
Public contact
Name of contact person
| 1st name | Haruki |
| Middle name | |
| Last name | Ishikawa |
Organization
Niigata University of Health and Welfare
Division name
Department of Health and Nutrition
Zip code
9503198
Address
#F202b 1398 Shimami-cho, Kita-ku niigata-shi, Niigata, JAPAN
TEL
0252574413
Homepage URL
whm22002@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Ethics Review Committee, Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku niigata-shi, Niigata, JAPAN
Tel
0252574455
rinri@nuhw.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
新潟医療福祉大学（新潟県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
27
Results
No cross-modal phenomena were identified in manifest attitudes, and no correlation with d-scores was found. No significant difference in WTP was observed between the round and square packages. The evaluation of latent attitudes revealed that subjects commonly made the intuitive association that round = sweet and square = sour.
Results date posted
| 2024 | Year | 03 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This experiment was conducted in compliance with the Declaration of Helsinki (World Medical Association) and the Ethical Guidelines for Medical Research Involving Human Subjects (MEXT, MHLW, METI) .
Subjects were 27 healthy female students in the first through fourth grades of the Department of Health and Nutrition at Niigata University of Health and Welfare who consented to participate in the study. Subjects were informed in writing and orally about the purpose, methods, uses of results, benefits and disadvantages, protection of personal information, and voluntary nature of research cooperation and freedom of withdrawal, and their written consent was obtained in advance.
Since it was necessary to conceal the original purpose of this study from the subjects, a cover story was used to request their cooperation in product development and as a survey of their preferences.
Participant flow
Subjects were asked to come to the room in a fasting state for 2 hours. Initially, subjects were asked to answer a basic survey about their hunger and physical condition using a questionnaire.
A preference survey was conducted by offering 60 g of lemon jelly in a round or square package, and subjects were asked to respond to the sweetness, acidity, liking, and whether they would like to eat it again using the 100 mm VAS method. The participants were then asked to indicate how much they would be willing to pay for a 120 g package of the jellies, assuming that they were sold in supermarkets. This process was repeated with a different package. The choice of which package was offered first was random.
The number of stimuli and the number of trials in this study followed the study by Fiszman et al. Subjects were instructed to keep their eyes on the center of the screen and to respond to the target stimulus as quickly and accurately as possible. In each block of trials, two stimuli (either one image and one word) were assigned to the left or right response key, and the other two stimuli were assigned to the other response key. Subjects responded by pressing one of two (E or I ) keys on the computer keyboard. Visual stimuli were displayed for 20 seconds or until a response was recorded. At the end of each trial, the system was set up to give feedback "X" if the subject's response was incorrect. If the response was incorrect, the subject was told in advance to press the correct key immediately. 5 repetitions occurred per image or word, for a total of 80 trials to obtain a d-score. In addition, 20 trials of one repetition were performed immediately before the beginning to help subjects memorize the flow of the IAT.
After answering the basic survey, which of the IAT and VAS methods was administered first was randomized to prevent bias. These experimental procedures were performed on the same day without any interval.
Adverse events
Free will is respected when explaining the study and obtaining consent; IAT involves continuous and monotonous movements, which may cause mental and physical strain. There is also a risk of COVID-19 infection due to the feeding. The duration of the restraint is approximately 20 minutes.
Outcome measures
d Score
100 mmVAS (sweet and sour, liking, would you eat it again)
Willingness to Pay
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 01 | Day |
Last modified on
| 2024 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055622
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
