Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| dsm-firmenich Switzerland AG | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin |
|
| Placebo | Placebo Comparator | visually identical placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12 mg Lutein + Zeaxanthin | Dietary Supplement | 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year |
|
| Measure | Description | Time Frame |
|---|---|---|
| Macular Pigment Optical Density | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Glare Disability | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
male, female, other, non-conforming
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Billy R Hammond, Ph.D. | University of Georgia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vision Sciences Laboratory, UGA | Athens | Georgia | 30602 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25468896 | Derived | 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. | |
| 23211814 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Key events:
Telephone screening to confirm eligibility Enrollment Randomization
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin Intervention: 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year |
| FG001 | Placebo | visually identical placebo Placebo: Visually identical placebo, taken once daily for one year |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 12 mg Lutein + Zeaxanthin | 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin Intervention: 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year |
| BG001 | Visually Identical Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Macular Pigment Optical Density | optical density of macular pigment layer of the neural retina at 30-minutes of retinal eccentricity | Participants who completed all four measurements | Posted | Mean | Standard Deviation | optical density | every three months for one year; 12-month measure reported. |
|
One year
Adverse event collection occurred over the phone at one month intervals, and during in-person follow-up visits every three months.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin Intervention: 10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year |
Not provided
Not provided
Sample included only young, healthy adults with acute vision. Because the sample was recruited from the local college student population, there were high rates of attrition (students moving away, forgetting appointments, discontinuing contact)
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Billy Hammond, Principal Investigator | University of Georgia | (706) 54204812 | bhammond@uga.edu |
Not provided
| ID | Term |
|---|---|
| D014975 | Lutein |
| D065146 | Zeaxanthins |
| ID | Term |
|---|---|
| D024341 | Xanthophylls |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 |
Not provided
Not provided
Two arms: nutritional supplement vs. placebo.
Not provided
Not provided
Not provided
| Visually identical placebo | Dietary Supplement | Visually identical placebo, taken once daily for one year |
|
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 | 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 |
visually identical placebo
Placebo: Visually identical placebo, taken once daily for one year
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Body mass index, computed from height (cm) and weight (kg) | Mean | Standard Deviation | kg/cm^2 |
|
| Iris Darkness | Visual inspection of iris color and comparison to an iris color scale on a computer monitor. Darkest irides score 1-2; Lightest irides score 4-5. | Mean | Standard Deviation | units on a scale |
|
|
|
|
| Secondary | Glare Disability | 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. | Posted | Mean | Standard Deviation | log relative energy | 12-month data point only |
|
|
|
|
| Secondary | Photostress Recovery Time | amount of time needed to recover from exposure to a bright light, and to regain sight of a visual target | Posted | Mean | Standard Deviation | seconds | improvement in recovery time; baseline recovery time (sec) minus 12-month recovery time (sec) |
|
|
|
|
| Secondary | Heterochromatic Contrast Sensitivity | 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. | Posted | Mean | Standard Deviation | log relative energy | 12-month data point only |
|
|
|
|
| 0 |
| 53 |
| 0 |
| 53 |
| 0 |
| 53 |
| EG001 | Placebo | visually identical placebo Placebo: Visually identical placebo, taken once daily for one year | 0 | 56 | 0 | 56 | 0 | 56 |
Not provided
Not provided
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |