Clinical trial NCT00909090: Macular Pigment and Glare Disability
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vision, Entoptic
Keywords: macular pigment
glare disability
lutein
photostress
chromatic contrast sensitivity
Lead sponsor: University of Georgia
Sponsor class: OTHER
Collaborators: name: DSM Nutritional Products, Inc.
First posted: 2009-05-27
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arms: nutritional supplement vs. placebo.
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Macular Pigment Optical Density
timeFrame: every three months for one year; 12-month measure reported.
Secondary outcomes:
measure: Glare Disability
timeFrame: 12-month data point only
measure: Photostress Recovery Time
timeFrame: improvement in recovery time; baseline recovery time (sec) minus 12-month recovery time (sec)
measure: Heterochromatic Contrast Sensitivity
timeFrame: 12-month data point only
Other outcomes:
Locations:
city: Athens
country: United States
facility: Vision Sciences Laboratory, UGA
state: Georgia
Study officials:
affiliation: University of Georgia
name: Billy R Hammond, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.