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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029432
Receipt No. R000033628
Scientific 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
Date of disclosure of the study information 2019/03/31
Last modified on 2018/04/03

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Basic information
Public 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
Acronym 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
Scientific 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Ochitani Daisuke
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code
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
1st name
Middle name
Last name Ochitani Daisuke
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code
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)

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
2019 Year 03 Month 31 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
2017 Year 09 Month 08 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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