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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Healthy subjects | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 16 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Results Delayed | |||||||
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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 | ||||||
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Other | |
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Management information | |||||||
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Last modified on |
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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 |