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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038490
Receipt No. 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 2019/11/05

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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
Email 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
Email doi_teppei@lotte.co.jp

Sponsor
Institute LOTTE CO.,LTD
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2019 Year 09 Month 11 Day
Date of IRB
Anticipated trial start date
2019 Year 11 Month 05 Day
Last follow-up date
2020 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Eating the functional foods

Management information
Registered date
2019 Year 11 Month 04 Day
Last modified on
2019 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043860

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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