UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031870
Receipt No. R000036392
Scientific Title The effect of supplement containing lutein on macular pigment optical density and visual performance
Date of disclosure of the study information 2018/03/23
Last modified on 2021/04/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Contact us.