UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038490 |
|---|---|
| Receipt number | R000043860 |
| Scientific Title | The study for reduction discomfort by having functional food during 3D video watching |
| Date of disclosure of the study information | 2019/11/04 |
| Last modified on | 2020/11/09 15:01:16 |
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Basic information
Public title
The study for reduction discomfort by having functional food during 3D video watching
Acronym
reduction discomfort test for 3D video watching
Scientific Title
The study for reduction discomfort by having functional food during 3D video watching
Scientific Title:Acronym
reduction discomfort test for 3D video watching
Region
| Japan |
Condition
Condition
motion sickness
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
reduction discomfort test for 3D video watching
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Score of Disorientation on SSQ(Simulation Sickness Questionnaire).
Key secondary outcomes
Scores of Nausea and Oculomotor on SSQ(Simulation Sickness Questionnaire).
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
10
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Eating the functional foods
Interventions/Control_2
Eating the functional foods
Interventions/Control_3
Eating the functional foods
Interventions/Control_4
Eating the functional foods
Interventions/Control_5
Eating the functional foods
Interventions/Control_6
Eating the functional foods
Interventions/Control_7
Eating the functional foods
Interventions/Control_8
Eating the functional foods
Interventions/Control_9
Eating the functional foods
Interventions/Control_10
Eating the functional foods
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Those who feel wandering when watching VR video for testing (SSQ score of 40 or more).
2. Those who can ban alcoholic beverages the day before the test
3. Those who have enough sleep on the day before the test and can manage the condition
Key exclusion criteria
1. Those who are pregnant or breastfeeding.
2. Those who have food allergies.
3. Those who have had severe symptoms in the past due to motion sickness
4. Those who never feel motion sickness
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Satoko |
| Middle name | |
| Last name | Okuyama |
Organization
LOTTE CO.,LTD
Division name
Health Science Section
Zip code
336-8601
Address
1-1, Numakage 3-chome, Minami-ku, Saitama
TEL
048-837-0170
okuyama_satoko@lotte.co.jp
Public contact
Name of contact person
| 1st name | Teppei |
| Middle name | |
| Last name | Doi |
Organization
LOTTE CO.,LTD
Division name
Health Science Section
Zip code
336-8601
Address
1-1, Numakage 3-chome, Minami-ku, Saitama
TEL
048-837-0170
Homepage URL
doi_teppei@lotte.co.jp
Sponsor or person
Institute
LOTTE CO.,LTD
Institute
Department
Personal name
Funding Source
Organization
LOTTE CO.,LTD
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
Shiba Palace Clinic institutional review board
Address
6F DaiwaA Hamamatsucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
Tel
03-5408-1599
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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 04 | 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
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 27 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 27 | Day |
Date trial data considered complete
| 2020 | Year | 01 | Month | 10 | Day |
Date analysis concluded
| 2020 | Year | 01 | Month | 17 | Day |
Other
Other related information
Eating the functional foods
Management information
Registered date
| 2019 | Year | 11 | Month | 04 | Day |
Last modified on
| 2020 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043860
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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