UMIN-ICDS Clinical Trial

Public title

Effects of intake of the test food on eye functions: A randomized double-blind placebo-controlled trial

Acronym

Effects of intake of the test food on eye functions

Scientific Title

Effects of intake of the test food on eye functions: A randomized double-blind placebo-controlled trial

Scientific Title:Acronym

Effects of intake of the test food on eye functions

Region

Japan

Condition

Healthy Japanese subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Effects of intake of the test food on eye functions.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Visual acuity

Key secondary outcomes

Percentage of pupillary response
Functional visual acuity
Visual analogue scale

Study type

Interventional

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. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of study food A for 6 weeks

Interventions/Control_2

Ingestion of control food (placebo) substance for 6 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

Age-lower limit

20

years-old

<=

Age-upper limit

64

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) Subjects of men and women aged 20 to 64
(2) Subjects of Japanese nationality who tend to feel tired eyes who perform VDT work on a daily basis
(3)Subjects with binocular corrected visual acuity of 1.0 or higher
(4) Subjects who do not change contact lenses or glasses used for correction during the test period
(5) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing.

Key exclusion criteria

(1) Subjects with a history of diabetes, liver disease, renal disease, digestive system disease, heart disease, respiratory disease, peripheral angiopathy, and other diseases that may affect the results of this study, or surgical history A subject
(2) Subjects with a disease or surgery history of eye
(3) Subjects undergoing ophthalmic treatment and using ophthalmic medications
(4) Subjects with abnormal liver and renal function tests
(5)Subjects with diseases currently being treated
(6) Subjects with food and drug allergies
(7) Subjects with anemia symptoms
(8) Subjects playing intense sports and on a diet
(9) Subjects with irregular lives
(10) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period
(11) Subjects who are continuously taking medicines (including OTC and prescription medicines)
(12) Subjects who are excessively ingesting alcohol
(13) Subjects who cannot stop drinking from the day before the test to the day of the test
(14) Subjects who are pregnant or plan to become pregnant or breastfeed during the study period
(15) Subjects who are participating in or will participate in other clinical trials at the start of this study, and within 4 weeks after the end of the study.
(16) Other subjects judged by the investigator to be inappropriate

Target sample size

60

Name of lead principal investigator

1st name	Naoki
Middle name
Last name	Miura

Organization

Miura Clinic, Medical Corporation Kanonkai

Division name

Internal Medicine

Zip code

530-0044

Address

Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka

TEL

0661355200

Email

info@miura-cl.jp

Name of contact person

1st name	Makoto
Middle name
Last name	Terashima

Organization

Oneness Support Co., Ltd.

Division name

Clinical Trial Division

Zip code

530-0044

Address

Higashitenma building 4F, 1-7-17, Higashitenma, Kita-ku, Osaka

TEL

0648018917

Homepage URL

Email

mterashima@oneness-sup.co.jp

Institute

Miura Clinic, Medical Corporation Kanonkai

Institute

Department

Personal name

Organization

BGG Japan Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Miura Clinic, Medical Corporation Kanonkai IRB

Address

Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka

Tel

0661355200

Email

mterashima@miura-cl.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人花音会みうらクリニック（大阪府）　Miura Clinic, Medical Corporation Kanonkai（Osaka）

Date of disclosure of the study information

2022

Year

04

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2021

Year

01

Month

07

Day

Date of IRB

2021

Year

01

Month

07

Day

Anticipated trial start date

2021

Year

01

Month

25

Day

Last follow-up date

2021

Year

04

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

01

Month

22

Day

Last modified on

2021

Year

02

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049191