UMIN-CTR Clinical Trial

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
Institute	HUMA R&D CORP
Institute
Department

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
URL(English)	https://upload.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

Contact us.