Macular Pigment and Glare Disability

NCT ID: NCT00909090

Last Updated: 2020-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 109 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2012-12-31

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.

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.

Conditions

Vision, Entoptic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention

10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin

Group Type: ACTIVE_COMPARATOR

12 mg Lutein + Zeaxanthin

Intervention Type: DIETARY_SUPPLEMENT

10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year

Placebo

visually identical placebo

Group Type: PLACEBO_COMPARATOR

Visually identical placebo

Intervention Type: DIETARY_SUPPLEMENT

Visually identical placebo, taken once daily for one year

Interventions

12 mg Lutein + Zeaxanthin

10 mg FloraGlo lutein + 2 mg Optisharp zeaxanthin, taken once daily for one year

Intervention Type: DIETARY_SUPPLEMENT

Visually identical placebo

Visually identical placebo, taken once daily for one year

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

FloraGlo lutein + OptiSharp zeaxanthin

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

DSM Nutritional Products, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Georgia

OTHER

Sponsor Role: lead

Responsible Party

Billy R. Hammond

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Billy R Hammond, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Georgia

Locations

Vision Sciences Laboratory, UGA

Athens, Georgia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25468896 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 23211814 (View on PubMed)

Other Identifiers

UGA-2009-10141-1

Identifier Type: -

Identifier Source: org_study_id