UMIN-CTR Clinical Trial

Public title

A study for the effects of ingestion of food containing plant extract and lutein on visual function.:A randomized, double-blind, placebo controlled trial

Acronym

A study for the effects of ingestion of food containing plant extract and lutein on visual function.

Scientific Title

A study for the effects of ingestion of food containing plant extract and lutein on visual function.:A randomized, double-blind, placebo controlled trial

Scientific Title:Acronym

A study for the effects of ingestion of food containing plant extract and lutein on visual function.

Region

Japan

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effects of ingestion of food containing plant extract and lutein on visual function

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Near point of accommodation (NPA)
Evaluate at points of 4-week, 8-week and 12-week.

Key secondary outcomes

Refractive power , best-corrected visual acuity, questionnaire

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

Food containing plant hishi extract and lutein, once a day for 12 weeks

Interventions/Control_2

Placebo without plant hishi extract and lutein, once a day for 12 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

40

years-old

<=

Age-upper limit

55

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) Men and women aged from 40 to 55.
(2) Subjects with subjective eye fatigue.
(3) A higher NPA at screening examination

Key exclusion criteria

(1) Subjects who have amblyopia or strabismus.
(2) Subjects who are judged as presbyopia (the control width is less than 2.5 D for dominant eye).
(3) Subjects who have an uncorrected serious refractive error for dominant eye.
(4) Subjects who have undergone ophthalmic surgery for dominant eye.
(5) Subjects who have a serious eye disease or history of eye disease.
(6) Subjects who have a disease (e.g., pollinosis) which may influence the outcome of the study
(7) Subjects who have been taking health foods containing plant hishi extract, lutein, vitamin E for 3 months or expected to use during study.
(8) Subjects who have been taking health foods or medicines which may have effects to the amplitude of accommodation (including eye fatigue) for 3 months or expected to use during study
(9) Subjects who have been taking health foods or medicines which may have effects to the stiffness of shoulder and neck for 3 months or expected to use during study
(10) Subjects who cannot execute a display work load test
(11) Subjects who may have allergy to the test foods
(12) Subjects who have under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease)
(13) Subjects who have under treatment of drug addiction and/or alcoholism
(14) Subjects who are participating other clinical studies or went back from an agreement acquisition day and participated in other clinical studies within 3 months or who are planning to participate other clinical studies during this study
(15) Subjects who are pregnant, breastfeeding, or planning to be pregnant or breastfeeding during study
(16) Subjects who are judged as unsuitable by doctor for laboratory value, anthropometric measurements, or physical examination value
(17) Subjects who are judged as unsuitable for lifestyle questionnaire
(18) Subjects who are judged as unsuitable by doctor for other reasons.

Target sample size

110

Name of lead principal investigator

1st name
Middle name
Last name	Futoshi Sakata

Organization

SANTEN PHARMACEUTICAL CO., LTD.

Division name

Sales & Marketing Division - OTC Products

Zip code

Address

1-13-7, Nihonbashi Muromachi, Chuo-ku, Tokyo

TEL

03-5299-8809

Email

Futoshi.sakata@santen.co.jp

Name of contact person

1st name
Middle name
Last name	Hiroyasu Shimada

Organization

TTC Co.,Ltd.

Division name

Clinical Research Planning Department

Zip code

Address

1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL

Email

h.shimada@ttc-tokyo.co.jp

Institute

TTC Co.,Ltd.

Institute

Department

Personal name

Organization

SANTEN PHARMACEUTICAL CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

2017

Year

03

Month

01

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

2016

Year

09

Month

15

Day

Date of IRB

Anticipated trial start date

2016

Year

10

Month

08

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

10

Month

07

Day

Last modified on

2017

Year

10

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028022