UMIN-CTR Clinical Trial

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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043860