UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058756 |
|---|---|
| Receipt number | R000067185 |
| Scientific Title | Verification of the effect of VR videos viewing on sensory evaluation during eating - Open-label trial parallel groups - |
| Date of disclosure of the study information | 2025/08/18 |
| Last modified on | 2025/08/11 13:36:54 |
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Basic information
Public title
The effect of watching VR videos on human senses while eating
Acronym
The impact of VR videos while eating
Scientific Title
Verification of the effect of VR videos viewing on sensory evaluation during eating - Open-label trial parallel groups -
Scientific Title:Acronym
Verification of the effect of VR videos viewing on sensory evaluation during eating
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirm what kind of effect watching VR videos has on sensory evaluation.
Basic objectives2
Others
Basic objectives -Others
Confirm changes in mood associated with ice cream consumption and corresponding changes in physiological indicators.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Autonomic nervous system indicators are measured during rest after device attachment, during consumption of the test food, and during subsequent rest.
Using rest before consumption of the test food as a baseline, the differences between rest, VR video viewing, consumption, and post-consumption are calculated, and exploratory comparisons are made between the control group and each VR group.
Key secondary outcomes
None
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food | Other |
Interventions/Control_1
Eat the test food in the sensory evaluation room.
Interventions/Control_2
Eat the test food while watching the VR video (sample A).
Interventions/Control_3
Eat the test food while watching the VR video (sample B).
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Healthy men and women aged 20 years or older.
2)Subjects who don't dislike vanilla ice cream.
3)Subjects who can prohibit themselves from taking alcohol on the day before trial.
4)Subjects who can sleep enough on the day before trial and keep their regular conditions.
5)Subjects who can prohibit the intake of caffeine,stimulants such as spices,and chocolate until the measurement time on the day of the trial.
Key exclusion criteria
Subjects with food allergies (milk and egg).
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Keishirou |
| Middle name | |
| Last name | Yoshida |
Organization
Lotte Co.,Ltd.
Division name
Research and Development Center Future Value R&D Department, Sensory Research Section
Zip code
336-8601
Address
1-1, Numakage 3-chome, Minami-ku, Saitama
TEL
048-837-0241
Yoshida_keishirou@lotte.co.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Sugai |
Organization
Lotte Co.,Ltd.
Division name
Research and Development Center Future Value R&D Department, Sensory Research Section
Zip code
336-8601
Address
1-1, Numakage 3-chome, Minami-ku, Saitama
TEL
048-837-0241
Homepage URL
Sugai_eriko@lotte.co.jp
Sponsor or person
Institute
Lotte Co.,Ltd.
Institute
Department
Personal name
Keishirou Yoshida
Funding Source
Organization
None
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
Ethical Committee of Shiba Palace clinic
Address
DaiwaA Hamamatsucho Building 6F, 1-9-10 Hamamatsucho, Minato-ku, Tokyo JAPAN
Tel
03-5408-1590
jimukyoku@mail.souken-r.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
株式会社ロッテ 中央研究所(埼玉県)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 18 | 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 | 07 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 12 | 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 | 08 | Month | 11 | Day |
Last modified on
| 2025 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067185
