UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029432 |
|---|---|
| Receipt number | 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 16:41:44 |
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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
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
ochitani@huma-c.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033628
