UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The randomized duble blind parallel-group comparison test of the effect for eye function of the Bilberry extract and Lutein
Title of the study (Brief title)	The randomized duble blind parallel-group comparison test of the effect for eye function of the Bilberry extract and Lutein
Region	Japan

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

Objectives
Narrative objectives1	To investigate the efficiency for eye function of the foods including bilberry extract and Lutein
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Near-reflex: intake 0,12 weeks
Key secondary outcomes	Contrast sensitivity: intake 0, 12 weeks MPOD: intake 0, 12 weeks Blood lutein concentration: intake 0, 12 weeks Subjective symptoms: intake 0,12 weeks Safety(blood test, urinary test, history taking):intake 0, 12 weeks

Base
Study type	Interventional

Study design
Basic design	Parallel
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	Bilberry extract 120mg/day, Lutein 6mg/day, 12weeks
Interventions/Control_2	Placebo, 12weeks
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	1, Healthy Japanese male and female 2, Aged=>20 years, <60 years 3, BMI =>25kg/m2 4, Subjects who feel eyestrain 5, Subjects who routinely carries out personal computer (PC) work or driving a car 6, Subjects who have not undergone LASIK. 7, Visual acuity with the naked eyes is 0.1 or more 8, Subjects who do not conscious of presbyopia 9, Subjects who can stop eye drops during the test period
Key exclusion criteria	1, Subjects who have previous medical history of serious diseases (e.g., cancer, cardiac arrest, cardiac infarct). 2, Subjects who have previous medical history and/or current medical history of serious diseases(e.g., arrhythmia, liver disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, other chronic diseases) 3, Subjects who have undergone gastrointestinal tract surgery; except appendectomy. 4, Subjects who take medicines. 5, Subjects who have an eye disease. 6, Subjects who are allergic to medicines or the test material of this trial. 7, Subjects who are or are possibly pregnant, or are lactating. 8, Subjects who participate in other clinical trials in the past 3 months. 9, Subjects who work time is irregular. 10, Smoker 11, Subjects who have been determined ineligible by principal investigator.
Target sample size	40

Research contact person
Name of lead principal investigator	Toru Katsuta
Organization	REFRE Co.,Ltd.
Division name	President
Address	1-7-28, Naka-cho, Ageo-city, Saitama
TEL	048-774-4011
Email	toru-katsuta@hc-refre.co.jp

Public contact
Name of contact person	Marie Kosehira
Organization	Omnica Co.,Ltd
Division name	Research and development Dept.
Address	TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN
TEL	03-5840-9811
Homepage URL
Email	kosehira@omnica.co.jp

Sponsor
Institute	Omnica Co.,Ltd
Institute
Department

Funding Source
Organization	REFRE Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
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	2017 Year 08 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 10 Day
Anticipated trial start date	2017 Year 08 Month 21 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	2017 Year 08 Month 18 Day
Last modified on	2018 Year 08 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032884