UMIN-CTR Clinical Trial

Public title

Effects of consumption of the test food on eye functions in healthy Japanese subjects

Acronym

Effects of consumption of the test food on eye functions in healthy Japanese subjects

Scientific Title

Effects of consumption of the test food on eye functions in healthy Japanese subjects: A randomized double-blind placebo-controlled trial

Scientific Title:Acronym

Effects of consumption of the test food on eye functions in healthy Japanese subjects

Region

Japan

Condition

Healthy Japanese subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the effects of consumption of the test food 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

Primary outcomes

The amount of change of percentage of pupillary response (average of both eyes) before and after VDT load between at examination before the start of test-food consumption (screening) and after four-week test-food consumption (4w).

Key secondary outcomes

1. The measured value of percentage of pupillary response (average of both eyes) before VDT load and after VDT load at examination after 4w

2-1. The measured value of percentage of pupillary response (average of both eyes, dominant eye, non-dominant eye) before VDT load and after VDT load at examination after 4w
2-2. The amount of change of percentage of pupillary response (average of both eyes) before VDT load and after VDT load between at screening and after 4w

3-1. The measured value of flicker value (average of both eyes, dominant eye, non-dominant eye) before VDT load, after VDT load, and before and after VTD load at examination after 4w
3-2. The amount of change of flicker value (average of both eyes, dominant eye, non-dominant eye) before VDT load, after VDT load, and before and after VTD load between at screening and after 4w

4-1. The measured value of "blood flow velocity", "visibility of vessels", "density of vessels", "diameter of vessels", "distance between vessels", "length of vessels" and "shape of vessels" before VDT load, after VDT load, and before and after VTD load at examination after 4w
4-2. The amount of change of "blood flow velocity", "visibility of vessels", "density of vessels", "diameter of vessels", "distance between vessels", "length of vessels" and "shape of vessels" before VDT load, after VDT load, and before and after VTD load between at screening and after 4w

5. The ratio of number of subjects of each shape of blood vessel after 4w

6-1. The measured value of subjective symptoms before VDT load, after VDT load, and before and after VTD load at examination after 4w
6-2. The amount of change of subjective symptoms before VDT load, after VDT load, and before and after VTD load between at screening and after 4w

7. The ratio of number of subjects of improving subjective symptoms before and after VTD load after 4w

Study type

Interventional

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

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Duration: Four weeks
Test food: Pintokurukashisu
Administration: Take three tablets once per day at any time between lunch and dinner with water without chewing.

* If you forget to take the test food, take it as soon as you remember within the day.

Interventions/Control_2

Duration: Four weeks
Test food: Placebo
Administration: Take three tablets once per day at any time between lunch and dinner with water without chewing.

* 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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Healthy Japanese 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, hemorrhagic disorder, intestinal disorder, 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 regularly take or may take antihypertensives, antiplatelet drug or anticoagulants

14. Subjects who may use anesthetics during the test period, such as surgery

15. Subjects who are allergic to medicines and/or the test food related products

16. Subjects who are pregnant, breast-feeding, and planning to become pregnant

17. 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

18 Subjects who are judged as ineligible to participate in the study by the physician

Target sample size

60

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

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

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

YASOUKOUSO.CO., Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Ario Nishiarai Eye Clinic

Medical Corporation Seishinkai, Takara Clinic

Name of secondary funder(s)

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

NO

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)

Date of disclosure of the study information

2020

Year

02

Month

03

Day

URL releasing protocol

Unpublished

Publication of results

Published

URL related to results and publications

http://www.newfoodindustry.com/cn7/2101.html

Number of participants that the trial has enrolled

66

Results

Kanai T, Takahashi Y, Takara T. Effects of the consumption of "Pintokuru-cassis" foods containing cassis extract on eye functions in healthy Japanese subjects: A randomized, placebo-controlled, double-blind, parallel-group comparison study. New Food Indust. 2021; 63(1): 3-21

Results date posted

2021

Year

04

Month

14

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2021

Year

01

Month

01

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

Recruitment status

Completed

Date of protocol fixation

2020

Year

01

Month

24

Day

Date of IRB

2020

Year

01

Month

24

Day

Anticipated trial start date

2020

Year

01

Month

30

Day

Last follow-up date

2020

Year

06

Month

05

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

02

Month

03

Day

Last modified on

2021

Year

05

Month

31

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044894