UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000036989
Receipt number	R000042139
Scientific Title	Effects of consumption of the test food on eye functions: A randomized double-blind placebo-controlled trial
Date of disclosure of the study information	2020/12/06
Last modified on	2021/05/27 11:10:08

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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

Healthy Japanese subjects

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

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

Institution consideration

Institution is not considered as adjustment factor.

Blocking

Concealment

Central registration

Intervention

No. of arms

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

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 or person

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042139