UMIN-CTR Clinical Trial

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
Email	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
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038336