UMIN-CTR Clinical Trial

Basic information
Public title	Study on the improvement of ocular function by continuous ingestion of food
Acronym	Study on the improvement of ocular function by continuous ingestion of food
Scientific Title	Study on the improvement of ocular function by continuous ingestion of food
Scientific Title:Acronym	Study on the improvement of ocular function by continuous ingestion of food
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 investigate the effect of the test food on the improvement of ocular function in men and women aged 20 years or older, 69 years or younger, who have received the test food continuously for 16 weeks.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Macular pigment optical density
Key secondary outcomes	Accommodative power

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	16-week intake of the test food
Interventions/Control_2	16-week intake of the placebo food
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)Japanese males and females aged 20 to 69 years old or younger at the time of obtaining informed consent 2)Patients who have a BMI 25 kilogram/m2 or less 3) Subjects with uncorrected or corrected visual acuity of 0.7 or higher for both eyes 4)Persons who have not undergone LASIK surgery(myopia correction surgery) 5)Persons who are regularly aware of eye fatigue 6)Those who can stop eye drops for astigmatism improvement during the test period 7)Persons who can be contacted by personal computers or smartphones 8)Those who were fully informed of the purpose and content of the study, were able to give consent, voluntarily volunteered to participate in the study, and agreed to participate in the study in writing.
Key exclusion criteria	1)Patients who are currently receiving any medication or outpatient treatment 2)Subjects currently undergoing exercise or diet therapy under the supervision of a physician. 3)Persons who are likely to develop allergies from test foods 4)People with pollinosis 5)Patients with current or past history of drug dependence or alcohol dependence 6)Patients who have been attending the hospital with psychiatric disorders (depression, etc.) or sleep disorders, or who have a history of psychiatric disorders in the past 7)Night or shift workers 8)Person who is extremely irregular in lifestyle such as eating and sleeping 9)Persons engaging in extreme prey 10)Patients with a current or past history of serious diseases such as diabetes mellitus, liver disease (hepatitis), renal disease, heart disease, etc., thyroid disease, adrenal disease, or other metabolic diseases. 11)Patients with ocular diseases other than refractive errors (hyperopia, myopia, astigmatism) 12)Persons with eyelashes extension 13)Persons who use health foods, supplements, and drugs that affect eye function. 14)Those who participated in another clinical study (study) within 3 months after the date of informed consent, or who are planned to participate in another clinical study (study) during the study period. 15)A blood sample exceeding 200 ml within 3 months or 400 ml within 3 months after the date of obtaining informed consent or a component blood donation. 16)Subjects who are currently pregnant or breast-feeding, or who may be pregnant or breastfeeding during the study period. 17)Current smokers or those who smoked within the past year 18)Persons who have difficulty complying with the records of various surveys 19)Subjects who are determined to be ineligible based on laboratory values and measurements at the time of SCR. 20)Other persons for whom the principal investigator judges to be inappropriate as subjects of the study.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Zip code	108-0014
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Email	ochitani@huma-rd.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	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Homepage URL
Email	ochitani@huma-rd.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	Limited company mycare
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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	2019 Year 02 Month 18 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	60
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	2019 Year 01 Month 11 Day
Date of IRB	2019 Year 01 Month 15 Day
Anticipated trial start date	2019 Year 02 Month 12 Day
Last follow-up date	2019 Year 06 Month 14 Day
Date of closure to data entry	2019 Year 06 Month 21 Day
Date trial data considered complete	2019 Year 07 Month 10 Day
Date analysis concluded	2019 Year 09 Month 25 Day

Other
Other related information

Management information
Registered date	2019 Year 02 Month 18 Day
Last modified on	2019 Year 10 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040872