UMIN-CTR Clinical Trial

Public title

Effect of Test Food Consumption on Visual Function.

Acronym

Effect of Test Food Consumption on Visual Function.

Scientific Title

Effect of Test Food Consumption on Visual Function.

Scientific Title:Acronym

Effect of Test Food Consumption on Visual Function.

Region

Japan

Condition

No

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to examine effect of test food consumption on visual function and its safety.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Schirmer's test (1)
(1): Screening , Observation Period I , Observation Period II .

Key secondary outcomes

*Secondary indexes
[1] Visual Analogue Scale (1)
[2] Tear film break-up time (2)

*Safety
[1] Blood pressure, pulsation (2)
[2] Weight, body fat percentage, BMI (2)
[3] Doctor's questions (2)
[4] Subject's diary (3)

*Other index
[1] Baseline characteristics (4)
[2] Height measurement (4)
[3] Hematologic test (4)
[4] Blood biochemical test (4)
[5] Urine analysis (4)
[6] General ophthalmologic examination (visual acuity, intraocular pressure measurement, fundus examination, slit-lamp microscopy, dominant eye judgement, refraction test) (4)

(1): Observation Period I, Observation Period II.
(2): Screening, Observation Period I, Observation Period II.
(3): Everyday from the starting day of Test Period I to the last day of the study.
(4): Screening.

Study type

Interventional

Basic design

Cross-over

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

Treatment

Type of intervention

Food

Interventions/Control_1

[1] Oral ingestion of a test food (1 tablet in a day; 2 weeks).
[2] Observation.
[3] Washout (2 weeks)
[4] Oral ingestion of a placebo food (1 tablet in a day; 2 weeks).
[5] Observation.

Interventions/Control_2

[1] Oral ingestion of a placebo food (1 tablet in a day; 2 weeks).
[2] Observation.
[3] Washout (2 weeks)
[4] Oral ingestion of a test food (1 tablet in a day; 2 weeks).
[5] Observation.

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

65

years-old

>

Gender

Male and Female

Key inclusion criteria

[1] Males and females aged 20-64 years.
[2] Individuals who are healthy and have no chronic physical disease.
[3] Individuals who are aware of eye fatigue due to daily VDT work or / and eye strain from driving a car.
[4] Individuals who engage in VDT work in their everyday life for 20 hours or more per week and 5 days per week (including time spent playing video games and operating computers and cell phones).
[5] Individuals who have binocular vision of 1.0 or better with naked eye or corrected vision, and who do not wear contact lenses, or are able to change to glasses during the examination period. [6] Individuals whose written informed consent has been obtained.
[7] Individuals who can come to the designated venue for this study and be inspected.
[8] Individuals judged appropriate for the study by the principal.

Key exclusion criteria

[1] Individuals using medical products.
[2] Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[3] Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease.
[4] Individuals who are a patient or have a history of or endocrine disease.
[5] Individuals who used a drug to treat a disease in the past 1 month.
[6] Individuals who use artificial tears more than 6 times a day in everyday life.
[7] Individuals who have been diagnosed with presbyopia or are aware of presbyopia.
[8] Individuals with eye diseases, entropion, or trichiasis.
[9] Individuals with a confirmed diagnosis of dry eye.
[10] Individuals who are using eye drops for the treatment of ocular diseases.
[11] Individuals who have refractive errors and have not been properly corrected.
[12] Individuals who have undergone LASIK vision restoration surgery.
[13] Individuals with high intensity astigmatism.
[14] Individuals whose eye fatigue is thought to be caused by a neurological disorder or other regulatory dysfunction.
[15] Individuals whose BMI is over 30kg/m2
[16] Individuals with drug and food allergies.
[17] Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements which claim to improve eye-related functions or contain active ingredients that are expected to have an effect on the eyes in the past 3 months or will ingest those foods during the test period.
[18] Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day).
[19] Individuals who may change their lifestyle during the examination period.
[20] Individuals who engage in a night work.
[21] Individuals who are or are possibly pregnant, or are lactating.
[22] Individuals who participated in other clinical studies in the past 3 months.
[23] Individuals judged inappropriate for the study by the principal.

Target sample size

20

Name of lead principal investigator

1st name	Atsushi
Middle name
Last name	Nakajima

Organization

Ueno-Asagao Clinic

Division name

Head

Zip code

110-0015

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

TEL

+81-3-6240-1162

Email

info@ueno-asagao.clinc

Name of contact person

1st name	Ryoma
Middle name
Last name	Shimizu

Organization

TES Holdings Co., Ltd.

Division name

Administrative Department of Clinical Trials

Zip code

110-0015

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

TEL

+81-3-6801-8480

Homepage URL

Email

r.shimizu@tes-h.co.jp

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name

Organization

Omnica Co.,Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ueno-Asagao Clinic Ethical Review Committee

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

Tel

+81528382485

Email

i.takahashi@tes-h.co.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

09

Month

10

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

Completed

Date of protocol fixation

2022

Year

08

Month

15

Day

Date of IRB

2022

Year

08

Month

17

Day

Anticipated trial start date

2022

Year

09

Month

23

Day

Last follow-up date

2022

Year

11

Month

13

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

09

Month

09

Day

Last modified on

2023

Year

08

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055614