UMIN-CTR Clinical Trial

Basic information
Public title	The effect of the supplementary capsule containing lutein on visual function in college student athletes
Acronym	The effect of lutein on visual function
Scientific Title	The effect of the supplementary capsule containing lutein on visual function in college student athletes
Scientific Title:Acronym	The effect of lutein on visual function
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of the daily supplementary capsule intake containing lutein on the visual function in college student athletes
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Kinetic Visual Acuity
Key secondary outcomes	Depth Perception Static Visual Acuity Questionnaire

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	The test food will be eaten for 35 days, and the visual function tests will be conducted before and after the ingestion.
Interventions/Control_2	The placebo food will be eaten for 35 days, and the visual function tests will be conducted before and after the ingestion.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male
Key inclusion criteria	A subject who is a male college student and belongs to the sports club of the college. A subject who is healthy and has not a food allergy and/or a drug allergy. A subject who does not plan to change his/her vision correction method. A subject who does/has not take/taken a drug and/or functional food which affects the test result during the current study period. A subject who has not been participating or is planning to participate in the other study at the start of the current study.
Key exclusion criteria	A subject who cannot observe the precautions regarding the intake of other supplement, the diet and the lifestyle, etc.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Keisuke Middle name Last name SAWAKI
Organization	Juntendo University
Division name	Faculty of Health and Sports Science
Zip code	270-1695
Address	1-1 Hiraka-gakuendai, Inzai
TEL	0476-98-1001
Email	ksawaki@juntendo.ac.jp

Public contact
Name of contact person	1st name Yoshimitsu Middle name Last name Kohmura
Organization	Juntendo University
Division name	Faculty of Health and Sports Science
Zip code	270-1695
Address	1-1 Hiraka-gakuendai, Inzai
TEL	0476-98-1001
Homepage URL
Email	ykoumura@juntendo.ac.jp

Sponsor
Institute	Juntendo University School of Health and Sports Science
Institute
Department

Funding Source
Organization	MARGAJAPAN Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	APO PLUS STATION CO., LTD.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the Ethics Committee of Juntendo University Faculty of Health and Sports Science
Address	1-1 Hiraka-gakuendai, Inzai
Tel	0476-98-1001
Email	sc-gradkyomu@juntendo.ac.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	2021 Year 11 Month 01 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	2021 Year 10 Month 29 Day
Date of IRB	2021 Year 10 Month 29 Day
Anticipated trial start date	2021 Year 11 Month 01 Day
Last follow-up date	2021 Year 12 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 10 Month 30 Day
Last modified on	2022 Year 04 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052434