UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for the effects of ingestion of food constituents derived from microorganism on visual function. : A double-blind, randomized, placebo controlled trial
Title of the study (Brief title)	A study for the effects of ingestion of food constituents derived from microorganism on visual function.
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the effects of ingestion of food constituents derived from microorganism on improving visual function.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Contrast sensitivity, Critical flicker frequency, visual analogue scale. Evaluate at points of 4-week and 8-week.
Key secondary outcomes	refract, best-corrected visual acuity, ear point distance (amplitude of accommodation), schirmer's test, DEQS

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 Constituent derived from microorganism, once a day for 8 weeks
Interventions/Control_2	Placebo not containing food Constituent derived from microorganism, once a day for 8 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	35 years-old <=
Age-upper limit	45 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)Men and women aged from 35 to 45. (2)Subjects with subjective eye fatigue. (3)Individuals who do the VDT works more than 6 hours a day for more than 1 year. (4)Individuals giving written informed consents in writing, after receiving enough explanation of the purpose and details of the study, understanding the study well, and deciding to attend the study with their own will. (5)Subjects who are judged suitable for this study by the investigator.
Key exclusion criteria	1 Subjects who have amblyopia or strabismus 2 Subjects who are judged as presbyopia (the control width is less than 2.5D 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 Best-corrected visual acuity<1.0 for dominant eye 6 Subjects who have a serious eye disease or history of eye disease 7 Subjects who are under treatment of some chronic disease and use medicines or medical supplies continuously 8 Subjects who have a history of serious disease (e.g., diabetes, liver disease, kidney disease, and/or heart disease) thyroid gland disease, adrenal gland disease, digestive system disease and/or metabolic disorder 9 Subjects who can't stop food similar to test foods or take drugs, health foods 10 Subjects with excessive alcohol-drinking behaviors 11 Subjects who regularly take drugs or health foods which may have effects to the eyes or expected to use during study 12 Subjects who can't stop take drugs or health foods which may have effects to immune functions 13 Subjects having allergy to food or medicine 14 Subjects who can't stop drinking for 2 days until the pre-check day and check days 15 Subjects who have a history of pollinosis 16 Subjects who have tendency to get diarrhea by eating dairy product 17 Subjects who have under treatment or a history of drug addiction and/or alcoholism 18 Subjects who and whose family work in a company developing or manufacturing functional foods 19 Subjects who can't execute a display work load test 20 Subjects who are participating or willing to participate in other clinical trials or in the last 3 months 21 Subjects who are or plan to be pregnant, breastfeeding during study 22 Subjects who are judged as unsuitable by doctor for anthropometric measurements or physical examination value 23 Subjects who are judged as unsuitable for lifestyle questionnaire 24 Subjects who are judged as unsuitable by doctor
Target sample size	60

Research contact person
Name of lead principal investigator	Masamaru Inaba
Organization	Inaba Eye Clinic
Division name	Director
Address	1F Osakaekimaedaiichi building, 1-3-1 ,Umeda, Kita-ku, Osaka, Japan
TEL	06-6343-2174
Email	inaba@ganka.com

Public contact
Name of contact person	Chiharu Goto
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	c.goto@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co.,Ltd.
Institute
Department

Funding Source
Organization	Kirin Company, Limited
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	2018 Year 01 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 13 Day
Anticipated trial start date	2016 Year 06 Month 03 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 06 Month 02 Day
Last modified on	2018 Year 06 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026036