MP-GD: Macular Pigment and Glare Disability
Study Details
Study Description
Brief Summary
The purpose of this study is:
-
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.
-
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.
-
To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will result in significantly reduced photostress recovery times.
-
To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will result in improved contrast enhancement.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Intervention 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin |
Dietary Supplement: 12 mg Lutein + Zeaxanthin
10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year
Other Names:
|
Placebo Comparator: Placebo visually identical placebo |
Dietary Supplement: Visually identical placebo
Visually identical placebo, taken once daily for one year
|
Outcome Measures
Primary Outcome Measures
- Macular Pigment Optical Density [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
Secondary Outcome Measures
- Glare Disability [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.
- Photostress Recovery Time [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
- Heterochromatic Contrast Sensitivity [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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Vision Sciences Laboratory, UGA | Athens | Georgia | United States | 30602 |
Sponsors and Collaborators
- University of Georgia
- DSM Nutritional Products, Inc.
Investigators
- Principal Investigator: Billy R Hammond, Ph.D., University of Georgia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UGA-2009-10141-1
Study Results
Participant Flow
Recruitment Details | Recruitment was initiated in May, 2009. The enrollment period was rolling and lasted for 30 months. Enrollment closed in November, 2011. Participants were recruited from the local Athens, Clarke-County community and the University of Georgia student population. |
---|---|
Pre-assignment Detail | Key events: Telephone screening to confirm eligibility Enrollment Randomization |
Arm/Group Title | Intervention | Placebo |
---|---|---|
Arm/Group Description | 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin Intervention: 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year | visually identical placebo Placebo: Visually identical placebo, taken once daily for one year |
Period Title: Overall Study | ||
STARTED | 53 | 56 |
COMPLETED | 36 | 39 |
NOT COMPLETED | 17 | 17 |
Baseline Characteristics
Arm/Group Title | 12 mg Lutein + Zeaxanthin | Visually Identical Placebo | Total |
---|---|---|---|
Arm/Group Description | 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin Intervention: 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year | visually identical placebo Placebo: Visually identical placebo, taken once daily for one year | Total of all reporting groups |
Overall Participants | 53 | 56 | 109 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
23.7
(4.61)
|
22.7
(3.32)
|
23.2
(3.97)
|
Sex/Gender, Customized (Count of Participants) | |||
Male |
22
41.5%
|
22
39.3%
|
44
40.4%
|
Female |
31
58.5%
|
34
60.7%
|
65
59.6%
|
Region of Enrollment (participants) [Number] | |||
United States |
53
100%
|
56
100%
|
109
100%
|
BMI (kg/cm^2) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [kg/cm^2] |
22.9
(2.45)
|
22.8
(2.66)
|
22.85
(2.56)
|
Iris Darkness (units on a scale) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [units on a scale] |
2.90
(1.31)
|
2.81
(1.27)
|
2.86
(1.29)
|
Outcome Measures
Title | Macular Pigment Optical Density |
---|---|
Description | optical density of macular pigment layer of the neural retina at 30-minutes of retinal eccentricity |
Time Frame | every three months for one year; 12-month measure reported. |
Outcome Measure Data
Analysis Population Description |
---|
Participants who completed all four measurements |
Arm/Group Title | Luten + Zeaxanthin | Placebo |
---|---|---|
Arm/Group Description | 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin Intervention: 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year | visually identical placebo Placebo: Visually identical placebo, taken once daily for one year |
Measure Participants | 36 | 39 |
Mean (Standard Deviation) [optical density] |
0.54
(0.10)
|
0.42
(0.10)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Luten + Zeaxanthin, Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.01 |
Comments | ||
Method | t-test, 2 sided | |
Comments |
Title | Glare Disability |
---|---|
Description | 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. |
Time Frame | 12-month data point only |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Intervention | Placebo |
---|---|---|
Arm/Group Description | 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin Intervention: 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year | visually identical placebo Placebo: Visually identical placebo, taken once daily for one year |
Measure Participants | 36 | 39 |
Mean (Standard Deviation) [log relative energy] |
1.81
(0.10)
|
1.83
(0.11)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Luten + Zeaxanthin, Placebo |
---|---|---|
Comments | Analysis compared mean differences between placebo and intervention at the 12-month time point. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.21 |
Comments | ||
Method | Regression, Linear | |
Comments |
Title | Photostress Recovery Time |
---|---|
Description | amount of time needed to recover from exposure to a bright light, and to regain sight of a visual target |
Time Frame | improvement in recovery time; baseline recovery time (sec) minus 12-month recovery time (sec) |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | 12 mg Lutein + Zeaxanthin | Visually Identical Placebo |
---|---|---|
Arm/Group Description | 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin Intervention: 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year | visually identical placebo Placebo: Visually identical placebo, taken once daily for one year |
Measure Participants | 36 | 39 |
Mean (Standard Deviation) [seconds] |
10.5
(7.5)
|
4.5
(6.0)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Luten + Zeaxanthin, Placebo |
---|---|---|
Comments | Analysis compared mean change from baseline to 12-month time points. | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.01 |
Comments | ||
Method | t-test, 1 sided | |
Comments |
Title | Heterochromatic Contrast Sensitivity |
---|---|
Description | 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. |
Time Frame | 12-month data point only |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | 12 mg Lutein + Zeaxanthin | Visually Identical Placebo |
---|---|---|
Arm/Group Description | 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin Intervention: 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year | visually identical placebo Placebo: Visually identical placebo, taken once daily for one year |
Measure Participants | 36 | 39 |
Mean (Standard Deviation) [log relative energy] |
1.21
(0.14)
|
1.16
(0.10)
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Luten + Zeaxanthin, Placebo |
---|---|---|
Comments | analysis conducted on mean change over one year, between groups | |
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.02 |
Comments | ||
Method | t-test, 2 sided | |
Comments |
Adverse Events
Time Frame | One year | |||
---|---|---|---|---|
Adverse Event Reporting Description | Adverse event collection occurred over the phone at one month intervals, and during in-person follow-up visits every three months. | |||
Arm/Group Title | Intervention | Placebo | ||
Arm/Group Description | 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin Intervention: 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year | visually identical placebo Placebo: Visually identical placebo, taken once daily for one year | ||
All Cause Mortality |
||||
Intervention | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/53 (0%) | 0/56 (0%) | ||
Serious Adverse Events |
||||
Intervention | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/53 (0%) | 0/56 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
Intervention | Placebo | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/53 (0%) | 0/56 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Dr. Billy Hammond, Principal Investigator |
---|---|
Organization | University of Georgia |
Phone | (706) 54204812 |
bhammond@uga.edu |
- UGA-2009-10141-1