MP-GD: Macular Pigment and Glare Disability

Sponsor
University of Georgia (Other)
Overall Status
Completed
CT.gov ID
NCT00909090
Collaborator
DSM Nutritional Products, Inc. (Industry)
109
1
2
43
2.5

Study Details

Study Description

Brief Summary

The purpose of this study is:
  1. 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.

  2. 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.

  3. To test the hypothesis that increases in MP (via 12 mg daily L + Z supplementation) will result in significantly reduced photostress recovery times.

  4. 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
  • Dietary Supplement: 12 mg Lutein + Zeaxanthin
  • Dietary Supplement: Visually identical placebo
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

Study Type:
Interventional
Actual Enrollment :
109 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two arms: nutritional supplement vs. placebo.Two arms: nutritional supplement vs. placebo.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
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
Study Start Date :
May 1, 2009
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 1, 2012

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:
  • FloraGlo lutein + OptiSharp zeaxanthin
  • 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

    1. 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

    1. 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.

    2. 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

    3. 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

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.
    Responsible Party:
    Billy R. Hammond, Professor, University of Georgia
    ClinicalTrials.gov Identifier:
    NCT00909090
    Other Study ID Numbers:
    • UGA-2009-10141-1
    First Posted:
    May 27, 2009
    Last Update Posted:
    Jul 13, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Billy R. Hammond, Professor, University of Georgia

    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

    1. Primary Outcome
    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
    2. Secondary Outcome
    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
    3. Secondary Outcome
    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
    4. Secondary Outcome
    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

    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)

    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
    Email bhammond@uga.edu
    Responsible Party:
    Billy R. Hammond, Professor, University of Georgia
    ClinicalTrials.gov Identifier:
    NCT00909090
    Other Study ID Numbers:
    • UGA-2009-10141-1
    First Posted:
    May 27, 2009
    Last Update Posted:
    Jul 13, 2020
    Last Verified:
    Jun 1, 2020