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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name