UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014854 |
|---|---|
| Receipt number | R000017209 |
| Scientific Title | Effects of supplementation of blueberry, lutein and propolis on eye fatigue |
| Date of disclosure of the study information | 2014/09/01 |
| Last modified on | 2014/08/13 15:45:38 |
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Basic information
Public title
Effects of supplementation of blueberry, lutein and propolis on eye fatigue
Acronym
Effects of supplementation of blueberry, lutein and propolis on eye fatigue
Scientific Title
Effects of supplementation of blueberry, lutein and propolis on eye fatigue
Scientific Title:Acronym
Effects of supplementation of blueberry, lutein and propolis on eye fatigue
Region
| Japan |
Condition
Condition
Eye fatigue
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of 2-week intake of dietary supplements containing bilberry, lutein, propolis on eye fatigue
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Working performance, eye fatigue sensation in visual analogue scale(VAS) and the Jikaku-sho shirabe under VDT operation
Key secondary outcomes
Tear volume measurement(Schirmer's test), autonomic nervous system function(spectrum analysis a-a interval of accelerated plethysmography) under VDT operation
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Effectiveness of 2-week intake of test food compared with placebo control
Interventions/Control_2
Effectiveness of 2-week intake of test food compared with baseline
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Healthy males and females aged from 30 to 59 years (bounds included)
2)Subject who has eye fatigue feeling under VDT operation
3)Subject having a briefing of the content of the present study, fully understanding and agreeing to its objective and being able to personally sign a written informed consent
Key exclusion criteria
1)Subject who has organic eye disease (cataract, glaucoma, etc.)
2)Subject receiving a medical treatment for serious renal, hepatic, cardio-vascular, respiratory, endocrine or metabolic disorders or having a medical history of these disorders
3)Subject regularly taking medicine, quasi drugs or health food which has some effect on eye fatigue
4)Subject having some food allergies
5)Subject having cedar or cypress pollen allergy
6)For female subjects: pregnancy or possibility of pregnancy, or intending to become pregnant during the study
7)Subject who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study
8)Subject deemed unsuitable by the investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osami Kajimoto |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Medical Science on Fatigue
Zip code
Address
1-4-3 Asahimachi, Abeno-ku, Osaka
TEL
06-6645-6171
kajimoto@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiro Sugino |
Organization
Soiken Inc.
Division name
R&D Division
Zip code
Address
Senri Life Science Center 13F, 1-4-2,Shinsenri-higashimachi,Toyonaka,Osaka
TEL
06-6871-8888
Homepage URL
sugino@soiken.com
Sponsor or person
Institute
Soiken Inc.
Institute
Department
Personal name
Funding Source
Organization
Yamada Bee Company, Inc.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2014 | Year | 09 | Month | 01 | 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
| 2014 | Year | 02 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
| 2014 | Year | 05 | Month | 19 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 13 | Day |
Last modified on
| 2014 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017209
