UMIN-CTR Clinical Trial

Basic information
Public title	Effect of the supplement on accommodation of the eye in middle- and old-aged adults: A randomized, double blinded, placebo controlled, and parallel group comparison study.
Acronym	Effect of the supplement on accommodation of the eye in middle- and old-aged adults
Scientific Title	Effect of the supplement on accommodation of the eye in middle- and old-aged adults: A randomized, double blinded, placebo controlled, and parallel group comparison study.
Scientific Title:Acronym	Effect of the supplement on accommodation of the eye in middle- and old-aged adults
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of the supplement on accommodation of the eye in middle- and old-aged adults after administration of the supplement for 4 weeks.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Accommodation of the eye
Key secondary outcomes

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	Ingestion of the test food for 4 weeks
Interventions/Control_2	Ingestion of the placebo for 4 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

Eligibility
Age-lower limit	35 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Japanese male and female aged 35 to 65 years old at the time of the informed consent. 2. Subject who has no eye diseases other than refractive error (dysregulation). 3. Subject whose naked vision for each eye is more than 0.2. 4. Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
Key exclusion criteria	1. Subject who is taking medication or under medical treatment. 2. Subject who is under exercise therapy or dietetic therapy. 3. Subject who has an allergy for test food. 4. Subject who has or had a history of either medicine or alcohol dependence syndrome. 5. Subject who has or had a history of mental illness (depression) or sleep disturbance. 6. Subject who is on a night-shift or is a shift worker. 7. Subject whose lifestyle is extremely irregular. 8. Subject who has an unbalanced diet. 9. Subject who has or had a history of disease in liver, kidney, cardiovascular system, gastrointestinal, lung, blood or metabolic function. 10. Subject who has or had a history of eye disease (Not include minor eye diseases). 11. Subject who can stop taking any kind of health food, supplement or medicine other than the test foods during the current study. 12. Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study. 13. Subject who has blood drawn 200mL within the past 1 months or 400mL within the past 3 months from the day of the consent acquisition. 14. Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating. 15. Subject who can't keep the daily records. 16. Subject who is judged as an inappropriate candidate according to the screening data. 17. Subject who is considered as an inappropriate candidate by the doctor in charge.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kei Yui
Organization	FANCL Corporation
Division name	Research Institute, Health science research center
Zip code
Address	12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL	045-820-3755
Email	ke-yui@fancl.co.jp

Public contact
Name of contact person	1st name Middle name Last name Masao Matsuoka
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Zip code
Address	Round Cross Tamachi. 10th Fl., 5-31-19 Shiba,Minato-ku,108-0014,Japan
TEL	03-3431-1260
Homepage URL
Email	matsuoka@huma-rd.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	FANCL Corporation
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
Address
Tel
Email

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	医療社団法人　幸野メディカルクリニック

Other administrative information
Date of disclosure of the study information	2019 Year 02 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
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 02 Month 01 Day
Date of IRB	2019 Year 02 Month 01 Day
Anticipated trial start date	2019 Year 02 Month 04 Day
Last follow-up date	2019 Year 04 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 02 Month 04 Day
Last modified on	2020 Year 02 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040717