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Macular Pigment and Glare Disability (MP-GD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by University of Georgia.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Georgia
ClinicalTrials.gov Identifier:
NCT00909090
First received: May 22, 2009
Last updated: August 10, 2011
Last verified: May 2011
History of Changes
  Purpose

The purpose of this study is:

I. To measure MP optical density (MPOD) spatial profiles in two groups (experimental and placebo) of 50 subjects each (N = 100), during an L + Z supplementation period of 12 months.

II. To test the hypothesis that increases in MP (via 12 mg daily L + Z 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 Intervention Phase
Glare Disability in Healthy Subjects
 Dietary Supplement: lutein and zeaxanthin supplements
Drug: Placebo
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:

Drug Information available for: Lutein
U.S. FDA Resources

Further study details as provided by University of Georgia:

Primary Outcome Measures:
  • Disability glare and contrast enhancement thresholds, photostress recovery times [ Time Frame: every three months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: LZ supplement
Lutein and zeaxanthin supplementation (12mg/day) will be compared to a placebo control for a one year duration.
 Dietary Supplement: lutein and zeaxanthin supplements
12 mg taken daily for one year
Other Name: The LZ supplement will be provided by DSM and Kemin
Placebo Comparator: Placebo
Lutein and zeaxanthin supplementation (12mg/day) will be compared to a placebo control for a one year duration.
 Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Gender: male or female
  • Age: 20 - 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 <20 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 HFP 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00909090

Locations
United States, Georgia
Vision Sciences Laboratory, UGA
Athens, Georgia, United States, 30602
Sponsors and Collaborators
University of Georgia
Investigators
Principal Investigator: Billy R Hammond, Ph.D. University of Georgia
  More Information

No publications provided by University of Georgia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Billy R. Hammond, Jr., Professor, PI, University of Georgia
ClinicalTrials.gov Identifier: NCT00909090     History of Changes
Other Study ID Numbers: UGA-2009-10141-1
Study First Received: May 22, 2009
Last Updated: August 10, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Georgia:
macular pigment
glare disability
lutein
photostress

ClinicalTrials.gov processed this record on May 21, 2013