UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of the effect of test food ingestion on eyesight
Acronym	Evaluation of the effect of test food ingestion on eyesight
Scientific Title	Evaluation of the effect of test food ingestion on eyesight
Scientific Title:Acronym	Evaluation of the effect of test food ingestion on eyesight
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to assess the effect of continuous intake of test food on depth perception and dynamic vision by comparison with control food
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Depth perception and dynamic vision before and after the intervention of eye abuse task
Key secondary outcomes	Near vision acuity and distance vision acuity before and after the intervention of eye abuse task, and visual malaise questionnaire Eye condition questionnaire

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	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of test food for 4 weeks
Interventions/Control_2	Ingestion of placebo for 4 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	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1) Male and female adult aged 20 or more and less than 65 years old 2) Subject with bilateral distant vision (unaided eye) of 0.6 or higher 3) Subject who can use electronic diary application (e-DCA) 4) Subject who received sufficient explanation about the purpose and content of the trial, had the ability to consent, volunteered to participate after understanding it well, and agreed to participate in the trial in writing.
Key exclusion criteria	1) Subject who has serious disorders on brain, hepatic, kidney, cardiac, lung, digestive organs, blood, endocrine system, and metabolic system 2) Subject who is under medication on a steady basis or history of medication for serious disorders 3) Subject currently undergoing treatment or with digestive diseases that affect the study or have a surgical history of digestive system(except appendicectomy) 4) Subject who has ophthalmic disease, has an ophthalmic surgical history, or regularly use eye drops for treatment or prevention 5) Subject who has history of sensitivity to the ingredients of test food 6) Subject who takes medications and supplements on a daily basis *Except subject who can cancel an intake of health foods and supplements during this trial 7) Subject who is pregnant, lactating mother, or who is willing to become pregnant during this trial 8) Any candidates considered to be ineligible for enrollment due to the results of health condition questionnaire*1 9) Subject who took part in the other clinical/monitoring trial within a month before giving informed consent to take part in this trial. 10) Any candidates considered to be unsuitable for enrollment in the opinion of the principal investigator *1:Those who smoke an average of 21 or more cigarettes in a day, drink an average of more than 20g of pure alcohol in a day more than 4 days a week, often skip two or more meals a day, work shifts at night etc.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Kouji Middle name Last name Furunishi
Organization	Kensou factory Co., Ltd.
Division name	-
Zip code	263-0021
Address	5-3-28 Todoroki-cho, Inage-ku, Chiba-shi, Chiba,Japan
TEL	080-9820-7352
Email	okada.kf@gmail.com

Public contact
Name of contact person	1st name Shigeru Middle name Last name Imai
Organization	Leverage Brain Inc.
Division name	Clinical Trial Department
Zip code	105-0004
Address	Shinbashi2-16-1 Minato-ku, Tokyo, Japan
TEL	080-7290-0404
Homepage URL
Email	imai@levbrain.com

Sponsor
Institute	Leverage Brain Inc.
Institute
Department

Funding Source
Organization	Maruga Japan 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	Japan Conference of Clinical Research
Address	1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
Tel	03-6868-7022
Email	jccr-info@cts-smo.com

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	2021 Year 11 Month 13 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	Terminated
Date of protocol fixation	2021 Year 10 Month 05 Day
Date of IRB	2021 Year 10 Month 21 Day
Anticipated trial start date	2021 Year 12 Month 10 Day
Last follow-up date	2022 Year 03 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 11 Month 01 Day
Last modified on	2022 Year 10 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052157