UMIN-CTR Clinical Trial

Public title

Effect of supplement on contrast sensitivity : a pilot study

Acronym

Effect of test supplement on contrast sensitivity

Scientific Title

Effect of supplement on contrast sensitivity : a pilot study

Scientific Title:Acronym

Effect of test supplement on contrast sensitivity

Region

Japan

Condition

Healthy adults

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aimed to verify the effect of test supplement on contrast sensitivity.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Contrast sensitivity

Key secondary outcomes

Macular pigment optical density, Subjective symptom questionnaire, Visual acuity, Best corrected visual acuity, Serum lutein and zeaxanthin concentration

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of test supplement for 24 consecutive weeks

Interventions/Control_2

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

45

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

(1) Subjects aged from 45 to 65 years old
(2) Subjects with low contrast sensitivity

Key exclusion criteria

(1) Subjects who have eye disease except refractive errors (e.g., Macular disease, optic media with advanced abnormalities)
(2) Subject who are myopia over -6D
(3) Subject who are daily corrected visual acuity less than 0.7 in both eyes
(4) Subjects who are best corrected visual acuity of less than 1.0
(5)Subjects who have under treatment or a history of serious disease (e.g., diabetes, liver disease, kidney disease, or heart disease)
(6)Subjects who have history of surgical resection of the gastrointestinal tract (except for appendectomy)
(7) Subjects who routinely take lutein or zeaxanthin containing supplement within the past year
(8) Subjects who have history of smoking within the past year
(9) Subjects who routinely take medicine (including eye drops) or health foods that may affect the results of this study
(10) Subjects who may have symptoms of hay fever during study period
(11) Subjects having possibilities for emerging allergy related to the study
(12) Subjects who are in long-term treatment (including medication, hospitalization, diet and exercise therapy )or are planning to take treatment during study period
(13) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(14) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on baseline examination
(15) Subjects who intend to become pregnant or lactating
(16) Subjects who have participated in other clinical study
(17) Subjects who are judged as unsuitable by doctor for other reasons

Target sample size

30

Name of lead principal investigator

1st name	Kei
Middle name
Last name	Yui

Organization

FANCL Corporation

Division name

Research Institute, Health science research center

Zip code

244-0806

Address

12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa

TEL

045-820-3755

Email

ke-yui@fancl.co.jp

Name of contact person

1st name	Hiroyasu
Middle name
Last name	Shimada

Organization

TTC Co.,Ltd.

Division name

Clinical Research Planning Department

Zip code

150-0021

Address

1-20-2, Ebisu-nishi, Shibuya-ku, Tokyo, Japan

TEL

03-5459-5329

Homepage URL

Email

h.shimada@ttc-tokyo.co.jp

Institute

TTC Co.,Ltd.

Institute

Department

Personal name

Organization

FANCL Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Aisei Hospital Ueno Clinic Research Ethics Committee

Address

2-18-6, Higashiueno, Taito-ku, Tokyo, Japan

Tel

03-6455-0880

Email

t.saito@ttc-smo.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人健昌会　福島健康管理センター
いきいきクリニック
稲葉眼科

Date of disclosure of the study information

2018

Year

07

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

30

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

2018

Year

06

Month

28

Day

Date of IRB

2018

Year

06

Month

28

Day

Anticipated trial start date

2018

Year

07

Month

17

Day

Last follow-up date

2019

Year

02

Month

03

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

07

Month

10

Day

Last modified on

2019

Year

07

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038022