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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000031400
Receipt No. R000035843
Scientific Title Verification of eye fatigue suppression effect by ingesting test foods. A placebo-controlled, Simple Randomization, open, cross over trial.
Date of disclosure of the study information 2018/02/21
Last modified on 2018/02/20

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Basic information
Public title Verification of eye fatigue suppression effect by ingesting test foods.
A placebo-controlled, Simple Randomization, open, cross over trial.
Acronym Verification of eye fatigue suppression effect by ingesting test foods.
Scientific Title Verification of eye fatigue suppression effect by ingesting test foods.
A placebo-controlled, Simple Randomization, open, cross over trial.
Scientific Title:Acronym 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
1st name
Middle name
Last name Kenji Oosawa
Organization Lotte Co., Ltd.
Division name Central Laboratory
Zip code
Address 1-1, Numakage-3chome, Minami-ku, Saitama
TEL 048-837-0275
Email Oosawa_Kenji@lotte.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Susumu Kanno
Organization Lotte Co., Ltd.
Division name Central Laboratory
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2018 Year 01 Month 06 Day
Date of IRB
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

Other
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

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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