UMIN-CTR Clinical Trial

Basic information
Public title	The effect of supplement containing lutein on macular pigment optical density and visual performance
Acronym	The effect of lutein supplement
Scientific Title	The effect of supplement containing lutein on macular pigment optical density and visual performance
Scientific Title:Acronym	The effect of lutein supplement
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the efficiency of supplement containing lutein on the macular pigment optical density and visual functions
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Macular pigment optical density (at 4,8,12,16 weeks after administration)
Key secondary outcomes	visual acuity contrast sensitivity glare sensitivity skin carotenoid levels skin AGEs levels

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	ngestion of supplementary drug containing lutein (16 weeks).
Interventions/Control_2
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	30 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	1.Healthy subjects aged 30 to 60 years-old 2. Macular pigment optical density of 0.64 or less in the measurement with Macular Metrics (Macular Metrics Inc.) at 0.5 eccentricity
Key exclusion criteria	1) Subjects with serious eye diseases 2) Visual acuity of less than 0.8 3) Myopia of -6.0 D and more 4) Subjects who have a gastrointestinal disorders such as malabsorption syndrome and history of gastrectomy causing absorption deficiency 5) Subjects who have under treatment of diabetes mellitus 6) Presence of cataract of a severity sufficient to affect the measurement of macular pigment 7) Pupil size less than 6.5 mm 8) Use of lutein and zeaxanthin supplements 9) Subjects who have an allergic to lutein, zeaxanthin or test food 10) Subjects who are in pregnancy, or lactation, or who planning to become pregnant or lactating during 11) Any candidates considered to be unsuitable for enrollment in the opinion of physician-in-charge
Target sample size	16

Research contact person
Name of lead principal investigator	1st name Akira Middle name Last name Obana
Organization	Seirei Hamamatsu General Hospital
Division name	Department of Ophthalmology
Zip code	430-8558
Address	2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, Shizuoka 430-8558, Japan
TEL	053-474-2222
Email	obana@sis.seirei.or.jp

Public contact
Name of contact person	1st name MItuo Middle name Last name Kimata
Organization	Seirei Hamamatsu General Hospital
Division name	Clinical research management center
Zip code	430-8558
Address	2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, Shizuoka 430-8558, Japan
TEL	053-474-1264
Homepage URL
Email	m-kimata@sis.seirei.or.jp

Sponsor
Institute	Deaprtment of Ophthalmology, Seirei Hamamatsu General Hospital
Institute
Department

Funding Source
Organization	WAKAMOTO PHARMACEUTICAL Co,,Ltd.
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	Seirei Hamamatsu General Hospital
Address	2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, Shizuoka 430-8558, Japan
Tel	053-474-2222
Email	hmchiken@sis.seirei.or.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	聖隷浜松病院眼科（静岡県）　Department of Ophthalmology, Seirei Hamamatsu General Hospital

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 23 Day

Related information
URL releasing protocol	DOI: 10.1038/s41598-020-66962-2
Publication of results	Published

Result
URL related to results and publications	DOI: 10.1038/s41598-020-66962-2
Number of participants that the trial has enrolled	16
Results	Total volume of macular pigment optical density (MPOD) within 9 degrees eccentricity significantly increased by week 8 and continued to increase until week 16 (p < 0.0001, two-way factorial ANOVA). Skin carotenoid levels increased significantly by week 4 and continued to increase until week 16 (p < 0.0001, two-way factorial ANOVA). All subjects completed the study without any serious adverse events.
Results date posted	2021 Year 04 Month 13 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Subjects were 16 Japanese, age 26-57 years.
Participant flow	Subjects took a supplement containing 20 mg/day of lutein, 4 mg/day of zeaxanthin, and other antioxidants (vitamin C, vitamin E, zinc, copper) for 16 weeks.
Adverse events	None
Outcome measures	Macular pigment optical density, Skin carotenoid optical density
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 03 Month 14 Day
Date of IRB	2018 Year 03 Month 22 Day
Anticipated trial start date	2018 Year 03 Month 26 Day
Last follow-up date	2018 Year 12 Month 20 Day
Date of closure to data entry	2019 Year 07 Month 10 Day
Date trial data considered complete	2019 Year 07 Month 19 Day
Date analysis concluded	2019 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date	2018 Year 03 Month 23 Day
Last modified on	2021 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036392

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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