UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study involving human subjects on an influence of continuous intake of a test food product for four weeks on visual fatigue among healthy adults
Title of the study (Brief title)	A study involving human subjects on an influence of continuous intake of a test food product for four weeks on visual fatigue among healthy adults
Region	Japan

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

Objectives
Narrative objectives1	To verify the improvement effects for eye fatigue through ingestion of the test food
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) Tonic accommodation test (HFC) 2) Accommodation capability test 3) Flicker test
Key secondary outcomes	VAS survey

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	4-week intake of the test food
Interventions/Control_2	4-week intake of the placebo food
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	49 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Age: 20 and over, below 50 2) Sex: Males and females with Japanese nationality 3) Subjective symptoms of visual fatigue 4) Daily use of home video game, a personal computer, and/or a smart phone, engaged in VDT work for at least 6 hours a day (*VDT work: work using a visual display terminal (VDT) with a display, a keyboard, etc., generally indicate work using a computer) 5) Those who can keep daily lifestyle during the study (no significant lifestyle change in the study period. Overseas travel and business travel are not permitted.) 6) Those who can continuously drink cocoa for four weeks 7) Those who can keep a journal everyday in the study period
Key exclusion criteria	1) Currently in treatment for any disease, particularly for an immune disease (such as Sjogren's syndrome) or presence of another severe disease 2) Previous history of a malignant disease such as a malignant tumor, cardiac failure, or cardiac infarction, or currently in treatment for a chronic disease 3) Currently in treatment with medication (including eye drops) or current intake of Chinese herbal medicine 4) Presence or previous history of allergic reaction to medication or a food product 5) Contact lens user 6) Those who have undergone eye surgery such as LASIK 7) Presence of pollinosis 8) Regular intake of a food product (specific examples: blueberry, bilberry, cassis, red wine, etc.), supplement, or medication (including eye drops and vitamin supplements) that has an affect on the study and possibly has a positive effect on eyes 9) Drinking cocoa on a daily basis 10) Participation in any other clinical study involving human subjects within 3 months or current participation in any other clinical study involving human subjects 11) Working on night shift or with alternative work schedule 12) Currently in treatment for drug addiction or drug abuse or previous history of drug addiction or drug abuse 13) Nursing or pregnant, or a possibility of becoming pregnant during the study 14) Clinical findings of presbyopia 15) Eyelash extensions
Target sample size	42

Research contact person
Name of lead principal investigator	Ochitani Daisuke
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Address	Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	81-3-3431-1260
Email	ochitani@huma-c.co.jp

Public contact
Name of contact person	Ochitani Daisuke
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Address	Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	81-3-3431-1260
Homepage URL
Email	ochitani@huma-c.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	Morinaga & 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	2019 Year 03 Month 31 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 08 Day
Anticipated trial start date	2017 Year 10 Month 12 Day
Last follow-up date	2017 Year 11 Month 26 Day
Date of closure to data entry	2017 Year 11 Month 30 Day
Date trial data considered complete	2017 Year 12 Month 01 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 10 Month 05 Day
Last modified on	2018 Year 04 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033628