UMIN-CTR Clinical Trial

Basic information
Public title	Effects of consumption of the test food on eye functions
Acronym	Effects of consumption of the test food on eye functions
Scientific Title	Effects of consumption of the test food on eye functions: A randomized double-blind placebo-controlled trial
Scientific Title:Acronym	Effects of consumption of the test food on eye functions
Region	Japan

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

Objectives
Narrative objectives1	To verify the effects of consumption of the test food for 6 weeks on eye functions in healthy Japanese subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Percentage of pupillary response (average of both eyes) *Compare the amount of change between before and after VDT load on between two groups at screening (before consumption) and 6 weeks after consumption
Key secondary outcomes	1. Percentage of pupillary response 1-1. average of both eyes 1-2. dominant eye 1-3. non-dominant eye 2. BUT (tear film break-up time) 2-1. average of both eyes 2-2. dominant eye 2-3. non-dominant eye 3. visual acuity 3-1. average of both eyes 3-2. dominant eye 3-3. non-dominant eye 4. Value of Schirmer's test 4-1. average of both eyes 4-2. dominant eye 4-3. non-dominant eye 5. Macular Pigment Optical Density (MPOD) level 5-1. average of both eyes 5-2. dominant eye 5-3. non-dominant eye 6. Muscle hardness 7. Questionnaire (the Likert scale) *1-1Assess at screening (before consumption) and 6 weeks after consumption, and compare between two groups for the measured values at before and after VDT load. *1-2, 1-3, 3, 6, 7 Assess at screening (before consumption) and 6 weeks after consumption, and compare between two groups for the measured values at before and after VDT load, and the amount of change between before and after VDT load. *2, 4, 5 Compare the measured values on between two groups at screening (before consumption) and 6 weeks after consumption.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 6 weeks Test food: Active capsule Administration: Take two capsules per day after breakfast with water. * If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2	Duration: 6 weeks Test food: Placebo Administration: Take two capsules per day after breakfast with water. * If you forget to take the test food, take it as soon as you remember within the day.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Healthy Japanese adult subjects 2. Subjects who are experiencing eye fatigue when they work on Visual Display Terminals (VDT) operation 3. Subjects who have corrected vision of both eyes with 1.0 or more and who do not use contact lenses, or who can switch to using eye glasses during the test period 4. Subjects who are judged as eligible to participate in the study by the physician 5. Subjects whose percentage of pupil constriction (average of both eyes) dropped at a relatively larger rate before and after VDT load at screening and examination before ingestion
Key exclusion criteria	1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who were diagnosed as presbyopia or are aware of presbyopia 5. Subjects who have eye diseases, entropion or trichiasis 6. Subjects who use eye drops for treatment of eye diseases 7. Subjects who have ametropia and do not be treated orthoptics properly 8. Subjects who were treated with LASIK 9. Subjects who are strong astigmatism 10. Subjects who are experiencing eye fatigue causing by nerve function and others (except accommodative function) 11. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 12. Currently taking medicines (include herbal medicines) and supplements 13. Subjects who are allergic to medicines and/or the test food related products 14. Subjects who are pregnant, breast-feeding, and planning to become pregnant 15. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 16. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	1st name Naoko Middle name Last name SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Zip code	112-0002
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	BGG Japan Co., Ltd. DHC Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Ario Nishiarai Eye Clinic Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address	9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel	03-5793-3623
Email	info@takara-clinic.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	アリオ西新井クリニック眼科 (東京都) Ario Nishiarai Eye Clinic (Tokyo, Japan) 医療法人社団盛心会 タカラクリニック (東京都) Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2020 Year 12 Month 06 Day

Related information
URL releasing protocol	Unpublished
Publication of results	Published

Result
URL related to results and publications	https://www.jstage.jst.go.jp/article/jcbn/advpub/0/advpub_20-149/_article/-char/ja
Number of participants that the trial has enrolled	44
Results	Kizawa Y, Sekikawa T, Kageyama M, Tomobe H, Kobayashi R, Yamada T. Effects of anthocyanin, astaxanthin, and lutein on eye functions: a randomized, double-blind, placebo-controlled study. Journal of Clinical Biochemistry and Nutrition. 2021; 20-149
Results date posted	2021 Year 05 Month 27 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2021 Year 02 Month 05 Day
Baseline Characteristics	Refer to the paper
Participant flow	Refer to the paper
Adverse events	Refer to the paper
Outcome measures	Refer to the paper
Plan to share IPD	Undecided
IPD sharing Plan description	To require consultation among related companies

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 05 Month 27 Day
Date of IRB	2019 Year 05 Month 27 Day
Anticipated trial start date	2019 Year 06 Month 08 Day
Last follow-up date	2019 Year 12 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 06 Month 07 Day
Last modified on	2021 Year 05 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042139