UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004593 |
|---|---|
| Receipt number | R000005486 |
| Scientific Title | The effects of 2 types of lutein supplements on macular pigment and visual functions |
| Date of disclosure of the study information | 2010/11/22 |
| Last modified on | 2021/04/13 12:28:49 |
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Basic information
Public title
The effects of 2 types of lutein supplements on macular pigment and visual functions
Acronym
Macular pigment and visual functions
Scientific Title
The effects of 2 types of lutein supplements on macular pigment and visual functions
Scientific Title:Acronym
Macular pigment and visual functions
Region
| Japan |
Condition
Condition
Macular degeneration
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the equality of 2 types of lutein supplements containing different lutein, Xanmax2002 and FloraGLO, on the increasing effects of macular pigment and plasma lutein concentrations in healthy persons. To investigate whether the increase in macular pigment improves retinal functions in a healthy eye.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Macular pigment optical density
Key secondary outcomes
1.Change in far and near visual acuity
2.Change in contrast sensitivity and glare-recovery testing
3.Change in response of macular electroretinogram
4.Change in plasma lutein concentration
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Xanmax 2002 lutein supplement
Interventions/Control_2
FloraGLO lutein supplement
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
No serious eye diseases
Visual acuity of 0.8 and more
Myopia of less than -6.0 D
No gastrointestinal disorders such as malabsorption syndrome and history of gastrectomy causing absorption deficiency
No diabetes mellitus
No use of lutein and zeaxanthin supplements
Non-smoker or no tobacco smoking within the past 1 year
Providing informed consent with sufficient understanding of the present study
Judged by the investigator to be eligible as a subject on the basis of screening tests
Not allergic to lutein or zeaxanthin
Key exclusion criteria
Presence of cataract of a severity sufficient to affect the measurement of macular pigment
Pupil size less than 6.5 mm
Judged by the investigator to be ineligible for other reasons
Target sample size
36
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 | Masahiro |
| Middle name | |
| Last name | Asano |
Organization
Seirei Hamamatsu General Hospital (Shizuoka Prefecture)
Division name
General Clinical Research Center
Zip code
430-8558
Address
2-12-12 Sumiyoshi, Naka-ku, Hamamatsu City, Shizuoka 430-8558, Japan
TEL
053-474-2222
Homepage URL
asanoma@sis.seirei.or.jp
Sponsor or person
Institute
Seirei Hamamatsu General Hospital (Shizuoka Prefecture)
Institute
Department
Personal name
Funding Source
Organization
Koyo Mercantile Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seirei Hamamatsu General Hospital
Address
Naka-ku
Tel
0534742222
yukogo@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Department of Ophthalmology, Seirei Hamamatsu General Hospital
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 22 | Day |
Related information
URL releasing protocol
10.1371/journal.pone.0139257
Publication of results
Published
Result
URL related to results and publications
10.1371/journal.pone.0139257
Number of participants that the trial has enrolled
36
Results
The mean serum lutein concentrations increased significantly after the first three months, but the mean MPOD levels in either supplement group did not show any statistically significant increase.
Results date posted
| 2021 | Year | 04 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2015 | Year | 10 | Month | 09 | Day |
Baseline Characteristics
Thirty-six healthy volunteers
Participant flow
Two products were used, FloraGLO(Kemin Japan) and XanMax (Katra Phytochem). The lutein particle size and zeaxanthin concentrations differed between the formulations. The subjects consumed one of the two supplements for a duration of up to 6 months.
Adverse events
None
Outcome measures
Macular pigment optical density, Serum lutein concentration, contrast sensitivity, glare sensitivity, visual acuity, focal electroretinogram
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2010 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 06 | Month | 04 | Day |
Date of closure to data entry
| 2012 | Year | 08 | Month | 02 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 10 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 06 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 20 | 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=R000005486
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