UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035171
Receipt number R000040087
Scientific Title A study examining the effects of continuous intake of test food on eye function and QOL
Date of disclosure of the study information 2018/12/09
Last modified on 2021/02/16 19:08:08

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Basic information

Public title

A study examining the effects of continuous intake of test food on eye function and QOL

Acronym

A study examining the effects of continuous intake of test food on eye function and QOL

Scientific Title

A study examining the effects of continuous intake of test food on eye function and QOL

Scientific Title:Acronym

A study examining the effects of continuous intake of test food on eye function and QOL

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine improvements of eye function and QOL in healthy adults with reduced eye function after continuously taking test drink for 12 weeks.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Eye fatigue measurement (high-frequency component-1)

Key secondary outcomes

Macular pigment optical density measurement, Contrast sensitivity measurement , Eye test, Subjective symptoms questionnaire to assess eye symptoms , Bowel habit questionnaire, Blood flow measurement


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Take 20 ml of test drink daily immediately after waking up.

Interventions/Control_2

Take 20 ml of placebo daily immediately after waking up.

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

60 years-old >

Gender

Male and Female

Key inclusion criteria

1.20 to 59 years old (at the time of submission of an informed consent document)
2.Healthy adults (who were judged as healthy individuals by the principal investigator)
3.Men and women
4.Those with subjective symptoms of eye fatigue
5.Non-smokers
6.Smartphone users (who can use electronic diaries)
7.Those who do not change their prescription of eyeglasses or contact lenses during the study period
8.Those who can continue to take test food for 3 months
9.Those who can provide their written informed consent

Key exclusion criteria

1.Those who currently receive some types of drug treatment (except for the drugs that are taken as needed)
2.Those who currently undergo dietary or exercise therapy under the supervision of a physician
3.Those with a history of treatment for malignant tumor, heart failure, or heart attack
4.Those who have undergone gastrointestinal surgery (except for appendectomy)
5.Those with a past medical history of any of the following: hepatic or other major disorders (kidneys, endocrine, cardiovascular, gastrointestine, lungs, blood, and metabolism), or complications of the disorders listed above
6.Those who have undergone laser-assisted in-situ keratomileusis in the past six months
7.Those with eye diseases, except for ametropia (hyperopia, myopia, and astigmatism)
8.Those who currently take health food (such as food products to maintain or restore health and supplements)
9.Those with a past and current medical history of drug or food allergy
10.Those who work irregularly, such as night shifts and irregular shifts
11.Those who have participated in another clinical trial within a month prior to submission of an informed consent document
12.Those who are currently pregnant or breastfeeding and those who desire a pregnancy
13.In the opinion of the principal investigator, those who were determined to be unsuitable for participation in this clinical trial

Target sample size

58


Research contact person

Name of lead principal investigator

1st name Kazuto
Middle name
Last name Terai

Organization

West Waseda eye Clinic

Division name

Director

Zip code

169-0075

Address

1-1-1, Takadanobaba , Shinjyuku, Tokyo, Japan

TEL

03-6380-2466

Email

kterai@wwec.jp


Public contact

Name of contact person

1st name Naomi
Middle name
Last name Yuzawa

Organization

IMEQRD Co., Ltd

Division name

Sales department

Zip code

104-0061

Address

6-2-1 Ginza Chuo-ku Tokyo Japan

TEL

03-6704-5968

Homepage URL


Email

n-yuzawa@imeqrd.co.jp


Sponsor or person

Institute

IMEQRD Co., Ltd

Institute

Department

Personal name



Funding Source

Organization

Kotohogi Co.,Ltd.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Suda Clinic institutional review board

Address

2-8-14,Takadanobaba,Shinjyuku,Tokyo

Tel

03-6704-5968

Email

n-yuzawa@imeqrd.co.jp


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



Other administrative information

Date of disclosure of the study information

2018 Year 12 Month 09 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 11 Month 27 Day

Date of IRB

2018 Year 11 Month 27 Day

Anticipated trial start date

2019 Year 01 Month 07 Day

Last follow-up date

2019 Year 04 Month 18 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 12 Month 07 Day

Last modified on

2021 Year 02 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040087


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name