UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031400 |
|---|---|
| Receipt number | 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 18:25:24 |
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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
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
Kanno_susumu@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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035843
