- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00909090
Macular Pigment and Glare Disability (MP-GD)
Effects of Lutein and Zeaxanthin Upon MPOD and Its Effects Upon Glare Disability, Photostress Recovery, and Contrast Enhancement in Healthy Subjects: A Randomized, Double-blind Placebo-controlled Study
The purpose of this study is:
I. To measure MP optical density (MPOD) in two groups (experimental and placebo) of 50 subjects each (N = 100), during an Lutein + Zeaxanthin supplementation period of 12 months.
II. To test the hypothesis that increases in MP (via 12 mg daily Lutein + Zeaxanthin supplementation) will result in significantly improved visual performance under disability glare conditions.
III. To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will result in significantly reduced photostress recovery times.
IV. To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will result in improved contrast enhancement.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The following measurements will be taken, before and after supplementation with lutein and zeaxanthin:
Macular pigment optical density (MPOD) Visual performance under glare conditions Photostress recovery times chromatic contrast sensitivity.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
-
Athens, Georgia, United States, 30602
- Vision Sciences Laboratory, UGA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Gender: male or female
- Age: 18 - 40 years
- BMI: 20-30
- No anticipated changes in dieting habits (as relevant to xanthophyll intake).
- No anticipated surgical procedures.
- Assessed as healthy, based on a pre-study examination including medical history, physical examination, and clinical laboratory. The examination will be performed by an MD or a Nurse Practitioner.
- Willingness and ability to give written informed consent and willingness and ability to comply with the study requirements.
- Corrected visual acuity (ETDRS): better than 20/60
Exclusion Criteria:
- BMI <20 or >30
- Age <18 or >40 years
- Smokers
- Current or history of relevant diseases (such as AMD)
- Corrected visual acuity worse than 20/60
- Inability to reliably perform MPOD measurements by heterochromatic flicker photometry or any of the other ophthalmic tests of the study.
- Any condition likely to interfere with normal gastro-intestinal absorption of xanthophylls.
- Current use of xanthophyll containing supplements
- Use of xanthophyll containing supplements in the past 6 months
- Participation in any other study during last 1 month.
- Blood donation during the last 3 months.
- Known hypersensitivity or allergy to xanthophylls.
- Regular intake of medications or supplements, which the principal investigator deems likely to confound the study outcomes.
- Suspected lack of compliance with any requirements of the study.
- Childbearing potential and unwillingness to refrain from acceptable anticonceptive measures (not including abstinence).
- Current pregnancy or breast feeding
- Any relevant abnormalities in the routine laboratory tests
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Intervention
10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin
|
10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year
Other Names:
|
PLACEBO_COMPARATOR: Placebo
visually identical placebo
|
Visually identical placebo, taken once daily for one year
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Macular Pigment Optical Density
Time Frame: every three months for one year; 12-month measure reported.
|
optical density of macular pigment layer of the neural retina at 30-minutes of retinal eccentricity
|
every three months for one year; 12-month measure reported.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glare Disability
Time Frame: 12-month data point only
|
light energy needed to obscure or veil a visual target; calculated as log-relative energy, which is the physical energy needed for the subject to report that the visual target has been veiled, given the intensity of the target, logged.
|
12-month data point only
|
Photostress Recovery Time
Time Frame: improvement in recovery time; baseline recovery time (sec) minus 12-month recovery time (sec)
|
amount of time needed to recover from exposure to a bright light, and to regain sight of a visual target
|
improvement in recovery time; baseline recovery time (sec) minus 12-month recovery time (sec)
|
Heterochromatic Contrast Sensitivity
Time Frame: 12-month data point only
|
amount of short-wave light energy necessary to obscure of veil a visual target, calculated as log-relative energy, which is the physical energy needed for the subject to report that the visual target has been veiled, given the intensity of the target, logged.
|
12-month data point only
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Billy R Hammond, Ph.D., University of Georgia
Publications and helpful links
General Publications
- Hammond BR, Fletcher LM, Roos F, Wittwer J, Schalch W. A double-blind, placebo-controlled study on the effects of lutein and zeaxanthin on photostress recovery, glare disability, and chromatic contrast. Invest Ophthalmol Vis Sci. 2014 Dec 2;55(12):8583-9. doi: 10.1167/iovs.14-15573.
- Hammond BR Jr, Fletcher LM, Elliott JG. Glare disability, photostress recovery, and chromatic contrast: relation to macular pigment and serum lutein and zeaxanthin. Invest Ophthalmol Vis Sci. 2013 Jan 17;54(1):476-81. doi: 10.1167/iovs.12-10411.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UGA-2009-10141-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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