UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for the effects of ingestion of food containing plant extract and lutein on visual function.:A randomized, double-blind, placebo controlled trial
Title of the study (Brief title)	A study for the effects of ingestion of food containing plant extract and lutein on visual function.
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of ingestion of food containing plant extract and lutein on visual function
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Near point of accommodation (NPA) Evaluate at points of 4-week, 8-week and 12-week.
Key secondary outcomes	Refractive power , best-corrected visual acuity, questionnaire

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	Prevention
Type of intervention	Food
Interventions/Control_1	Food containing plant hishi extract and lutein, once a day for 12 weeks
Interventions/Control_2	Placebo without plant hishi extract and lutein, once a day for 12 weeks
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	40 years-old <=
Age-upper limit	55 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Men and women aged from 40 to 55. (2) Subjects with subjective eye fatigue. (3) A higher NPA at screening examination
Key exclusion criteria	(1) Subjects who have amblyopia or strabismus. (2) Subjects who are judged as presbyopia (the control width is less than 2.5 D for dominant eye). (3) Subjects who have an uncorrected serious refractive error for dominant eye. (4) Subjects who have undergone ophthalmic surgery for dominant eye. (5) Subjects who have a serious eye disease or history of eye disease. (6) Subjects who have a disease (e.g., pollinosis) which may influence the outcome of the study (7) Subjects who have been taking health foods containing plant hishi extract, lutein, vitamin E for 3 months or expected to use during study. (8) Subjects who have been taking health foods or medicines which may have effects to the amplitude of accommodation (including eye fatigue) for 3 months or expected to use during study (9) Subjects who have been taking health foods or medicines which may have effects to the stiffness of shoulder and neck for 3 months or expected to use during study (10) Subjects who cannot execute a display work load test (11) Subjects who may have allergy to the test foods (12) Subjects who have under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease) (13) Subjects who have under treatment of drug addiction and/or alcoholism (14) Subjects who are participating other clinical studies or went back from an agreement acquisition day and participated in other clinical studies within 3 months or who are planning to participate other clinical studies during this study (15) Subjects who are pregnant, breastfeeding, or planning to be pregnant or breastfeeding during study (16) Subjects who are judged as unsuitable by doctor for laboratory value, anthropometric measurements, or physical examination value (17) Subjects who are judged as unsuitable for lifestyle questionnaire (18) Subjects who are judged as unsuitable by doctor for other reasons.
Target sample size	110

Research contact person
Name of lead principal investigator	Futoshi Sakata
Organization	SANTEN PHARMACEUTICAL CO., LTD.
Division name	Sales & Marketing Division - OTC Products
Address	1-13-7, Nihonbashi Muromachi, Chuo-ku, Tokyo
TEL	03-5299-8809
Email	Futoshi.sakata@santen.co.jp

Public contact
Name of contact person	Hiroyasu Shimada
Organization	TTC Co.,Ltd.
Division name	Clinical Research Planning Department
Address	1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	h.shimada@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co.,Ltd.
Institute
Department

Funding Source
Organization	SANTEN PHARMACEUTICAL 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 03 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 15 Day
Anticipated trial start date	2016 Year 10 Month 08 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	2016 Year 10 Month 07 Day
Last modified on	2017 Year 10 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028022