UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022586 |
|---|---|
| Receipt number | R000026036 |
| Scientific Title | A study for the effects of ingestion of food constituents derived from microorganism on visual function. : A double-blind, randomized, placebo controlled trial |
| Date of disclosure of the study information | 2018/01/31 |
| Last modified on | 2018/06/04 18:41:24 |
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Basic information
Public title
A study for the effects of ingestion of food constituents derived from microorganism on visual function. : A double-blind, randomized, placebo controlled trial
Acronym
A study for the effects of ingestion of food constituents derived from microorganism on visual function.
Scientific Title
A study for the effects of ingestion of food constituents derived from microorganism on visual function. : A double-blind, randomized, placebo controlled trial
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Masamaru Inaba |
Organization
Inaba Eye Clinic
Division name
Director
Zip code
Address
1F Osakaekimaedaiichi building, 1-3-1 ,Umeda, Kita-ku, Osaka, Japan
TEL
06-6343-2174
inaba@ganka.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chiharu Goto |
Organization
TTC Co.,Ltd.
Division name
Clinical Research Planning Department
Zip code
Address
1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL
03-5459-5329
Homepage URL
c.goto@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co.,Ltd.
Institute
Department
Personal name
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)
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
| 2018 | Year | 01 | 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
| 2016 | Year | 05 | Month | 13 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026036
