UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033854
Receipt number R000038572
Scientific Title A randomized, placebo-controlled, double-blind, parallel-group trial of the improvement in ocular function with continued lutein intake
Date of disclosure of the study information 2018/09/04
Last modified on 2019/05/13 17:54:37

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Basic information

Public title

A randomized, placebo-controlled, double-blind, parallel-group trial of the improvement in ocular function with continued lutein intake

Acronym

A randomized, placebo-controlled, double-blind, parallel-group trial of the improvement in ocular function with continued lutein intake

Scientific Title

A randomized, placebo-controlled, double-blind, parallel-group trial of the improvement in ocular function with continued lutein intake

Scientific Title:Acronym

A randomized, placebo-controlled, double-blind, parallel-group trial of the improvement in ocular function with continued lutein intake

Region

Japan


Condition

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is to evaluate the effect of the study food containing lutein on ocular function in healthy Japanese men and women aged 20 years or older and 69 years or younger who continue to consume the food for 16 weeks.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Macular pigment optical density

Key secondary outcomes

Serum lutein concentration, contrast sensitivity


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

16-week intake of the containing lutein food of 2 capsules a day

Interventions/Control_2

16-week intake of the placebo food of 2 capsules a day

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

69 years-old >=

Gender

Male and Female

Key inclusion criteria

1)Healthy Japanese men and women aged 20 to 69 years at the time of informed consent
2)Persons with a BMI 25 kg of less than or equal to m2
3)Patients who have not undergone LASIK surgery (myopia correction surgery)
4)Patients with 0.7 or more corrected visual acuity in both eyes
5)Persons who can be contacted by personal computer or smartphone
6)Patients who can discontinue ophthalmic solutions during the study period.
7)A person who has received sufficient explanation on the purpose and content of the research, who has the ability to give consent, who voluntarily volunteers to participate in the research with a good understanding, and who has given written consent to participate in the research.

Key exclusion criteria

1)A person who is currently receiving any drug treatment or ambulatory treatment.
2)A person who is currently exercising or taking diet under the supervision of a physician.
3)Patients with a history of, present disease, or complication of liver disease or serious renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease.
4)Patients with chronic diseases (arrhythmias, hepatic disorders, renal disorders, cerebrovascular disorders, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or other chronic diseases) who are being treated or have a history
5)Patients who have undergone gastrointestinal surgery (appendicitis is acceptable)
6)Patients with eye diseases other than refractive error (hyperopia, myopia, astigmatism)
7)Persons with a history of drug or food allergy
8)People who wish to do so during pregnancy, lactation, or the duration of the study
9)Persons who have received blood donations or immunizations within the last 3 months or who plan to receive them during the study period.
10)Persons who routinely consume health foods, supplements, and pharmaceuticals that may affect ocular function.
11)Persons with psychiatric disorders (depression, etc.) or sleep disorders who are attending hospital or who have a history of psychiatric illness in the past
12)Alcoholics, addicts, or abusers with or without a history of treatment
13)Persons who work on a shift basis, such as those who work at night
14)Persons with extremely irregular lifestyle habits such as diet and sleep
15)Current smokers
16)Currently participating in other clinical trials or participating in other clinical trials within the last 3 months of the date of informed consent
17)Persons with difficulties in observing records on various questionnaires
18)Other persons who are judged by the investigator to be inappropriate for the study.

Target sample size

62


Research contact person

Name of lead principal investigator

1st name Kosehira
Middle name
Last name Marie

Organization

Omnica Co.,Ltd

Division name

Research and development Dept.

Zip code

112-0002

Address

TN Koishikawa BLDG. 5F, 1-15-17 Koishikawa, Bunkyo-ku, Tokyo, JAPAN

TEL

03-5840-9815

Email

kosehira@omnica.co.jp


Public contact

Name of contact person

1st name Daisuke
Middle name
Last name Ochitani

Organization

HUMA R&D CORP

Division name

Clinical Development Division

Zip code

108-0014

Address

Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan

TEL

81-3-3431-1260

Homepage URL


Email

ochitani@huma-rd.co.jp


Sponsor or person

Institute

HUMA R&D CORP

Institute

Department

Personal name



Funding Source

Organization

Omnica Co.,Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committees of Nihonbashi Egawa Clinic

Address

2F Kotobuki Build. 1-27-12 Yaesu Chuo-ku, Tokyo 103-0028 Japan

Tel

03-5204-0311

Email

jim@medipharma.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 09 Month 04 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

62

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 08 Month 10 Day

Date of IRB

2018 Year 08 Month 13 Day

Anticipated trial start date

2018 Year 09 Month 05 Day

Last follow-up date

2019 Year 01 Month 19 Day

Date of closure to data entry

2019 Year 01 Month 21 Day

Date trial data considered complete

2019 Year 02 Month 06 Day

Date analysis concluded

2019 Year 05 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 08 Month 22 Day

Last modified on

2019 Year 05 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038572


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name