UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033619 |
|---|---|
| Receipt number | R000038336 |
| Scientific Title | A study for the effect of intake of food derived from microorganism on eye strain |
| Date of disclosure of the study information | 2020/05/31 |
| Last modified on | 2020/06/29 19:53:44 |
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Basic information
Public title
A study for the effect of intake of food derived from microorganism on eye strain
Acronym
A study for the effect of intake of food derived from microorganism on eye strain
Scientific Title
A study for the effect of intake of food derived from microorganism on eye strain
Scientific Title:Acronym
A study for the effect of intake of food derived from microorganism on eye strain
Region
| Japan |
Condition
Condition
None (Healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of intake of food derived from microorganism on eye strain
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tests for eye strain
Key secondary outcomes
Questionnaires
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
Capsule containing food derived from microorganism, once a day for 8 weeks
Interventions/Control_2
Capsule not containing food 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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy Japanese men and women aged from 35 to less than 50 years old
(2) Subjects with subjective eye strain
(3) Subjects who are judged as suitable for this study by the investigator
Key exclusion criteria
(1) Subjects who are under treatment of or have history of cancer, heart failure and myocardial infarction
(2) Subjects who are under treatment of or have history of chronic diseases
(3) Subjects who are diagnosed with or aware of presbyopia
(4) Subjects who have eye disease
(5) Subjects who are diagnosed with asthenopia
(6) Subjects who use eye drops for eye disease
(7) Subjects who have an uncorrected serious refractive error
(8) Subjects who had LASIK surgery
(9) Subjects who have serious astigmatism
(10) Subjects who have amblyopia or strabismus
(11) Subjects whose best-corrected visual acuity is < 1.0
(12) Subjects who are diagnosed with eye strain caused by anything except for neurogenic or adjust function
(13) Subjects who work in a company developing functional foods
(14) Subjects with excessive alcohol-drinking
(15) Subjects who can't stop drinking alcohol for 2 days until the check days
(16) Subjects who usually take or will take drugs or health foods for eye
(17) Subjects who can't stop take drugs or health foods for regulation of immune functions
(18) Subjects who can't stop eating foods similar to the test foods and/or can't stop taking drugs or health foods including lactic acid bacteria or Bifidobacterium
(19) Subjects who have tendency to get diarrhea by eating dairy products
(20) Subjects who have risk to develop allergy caused by foods or drugs
(21) Subjects who have drug dependence or allergy dependence
(22) Subjects who are diagnosed with hay fever
(23) Subjects who can't complete workload for eye strain
(24) Subjects who are not suitable for this study by results of lifestyle questionnaire
(25) Subjects who are or are planning to be pregnant or breastfeeding during this study
(26) Subjects who participated in other clinical trial within 3 months prior to obtaining informed consent, or are planning to participate other clinical trial
(27) Subjects who are judged as unsuitable for participating this study by the investigator
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Morita |
Organization
Kirin Company, Limited
Division name
Research Laboratories for Health Science & Food Technologies, Research & Development Division
Zip code
Address
1-13-5, Fukuura Kanazawa-ku, Yokohama, Kanagawa Japan
TEL
045-788-7200
Yuji_Morita@kirin.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoko Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
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
アリオ西新井クリニック眼科（東京）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | 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
| 2018 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 03 | Day |
Last modified on
| 2020 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038336
