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Macular Pigment and Glare Disability (MP-GD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00909090
Recruitment Status : Completed
First Posted : May 27, 2009
Results First Posted : July 13, 2020
Last Update Posted : July 13, 2020
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Billy R. Hammond, University of Georgia

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Vision, Entoptic Dietary Supplement: 12 mg Lutein + Zeaxanthin Dietary Supplement: Visually identical placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Lutein

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 Name: FloraGlo lutein + OptiSharp zeaxanthin

Placebo Comparator: Placebo
visually identical placebo
Dietary Supplement: Visually identical placebo
Visually identical placebo, taken once daily for one year




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   male, female, other, non-conforming
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00909090


Locations
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United States, Georgia
Vision Sciences Laboratory, UGA
Athens, Georgia, United States, 30602
Sponsors and Collaborators
University of Georgia
DSM Nutritional Products, Inc.
Investigators
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Principal Investigator: Billy R Hammond, Ph.D. University of Georgia
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Results First Posted: July 13, 2020
Last Update Posted: July 13, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Billy R. Hammond, University of Georgia:
macular pigment
glare disability
lutein
photostress
chromatic contrast sensitivity