UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verification of eye fatigue suppression effect by ingesting test foods. A placebo-controlled, Simple Randomization, open, cross over trial.
Title of the study (Brief title)	Verification of eye fatigue suppression effect by ingesting test foods.
Region	Japan

Condition
Condition	healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Verify the eye fatigue suppression effect by ingesting test foods while working on a personal computer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Subject's assessment of eye fatigue before and after PC work (VAS method)
Key secondary outcomes	Subject's spherical equivalent, accommodative power and and self-evaluation of eyes (VAS method) before and after PC work

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	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of 4 test foods during 60 minutes of PC work (1 day) ->Ingestion of 4 control foods during 60 minutes of PC work (1 day)
Interventions/Control_2	Ingestion of 4 control foods during 60 minutes of PC work (1 day) ->Ingestion of 4 test foods during 60 minutes of PC work (1 day)
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	20 years-old <=
Age-upper limit	50 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Healthy males and females from 20 to 49 years of age (2) Subjects have no eye diseases other than myopia / astigmatism (in the case of astigmatism, the cylinder power is up to -1.50 D and it is possible to correct) (3) Subjects who can test without wearing glasses (4) Subjects have more than 40/40 vision for both eyes by naked eye or contact lens wearing (5) Subjects giving written informed consent
Key exclusion criteria	(1) Individuals who have symptoms that affect test food intake (2) Currently, individuals are receiving treatment some diseases. Or individuals are using supplements or health foods for eye (3) Individuals presenting known food allergy in connection with the exam (4) Individuals who are pregnant (5) Individuals with excessive presbyopia (6) Individuals who feel that it is difficult to keep eating test foods during test time (7) Individuals who are judged as unsuitable for the study by the investigator
Target sample size	10

Research contact person
Name of lead principal investigator	Kenji Oosawa
Organization	Lotte Co., Ltd.
Division name	Central Laboratory
Address	1-1, Numakage-3chome, Minami-ku, Saitama
TEL	048-837-0275
Email	Oosawa_Kenji@lotte.co.jp

Public contact
Name of contact person	Susumu Kanno
Organization	Lotte Co., Ltd.
Division name	Central Laboratory
Address	1-1, Numakage-3chome, Minami-ku, Saitama
TEL	048-837-0187
Homepage URL
Email	Kanno_susumu@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)

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	2018 Year 02 Month 21 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 01 Month 06 Day
Anticipated trial start date	2018 Year 02 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 02 Month 21 Day
Last modified on	2018 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035843