UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031870 |
|---|---|
| Receipt number | 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 17:19:46 |
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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
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
m-kimata@sis.seirei.or.jp
Sponsor or person
Institute
Deaprtment of Ophthalmology, Seirei Hamamatsu General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036392
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