Overview

This trial is active, not recruiting.

Condition glare disability in healthy subjects
Treatments lutein and zeaxanthin supplements, placebo
Phase phase 2/phase 3
Sponsor University of Georgia
Start date May 2009
End date December 2011
Trial size 100 participants
Trial identifier NCT00909090, UGA-2009-10141-1

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
Lutein and zeaxanthin supplementation (12mg/day) will be compared to a placebo control for a one year duration.
lutein and zeaxanthin supplements The LZ supplement will be provided by DSM and Kemin
12 mg taken daily for one year
(Placebo Comparator)
Lutein and zeaxanthin supplementation (12mg/day) will be compared to a placebo control for a one year duration.
placebo
Placebo

Primary Outcomes

Measure
Disability glare and contrast enhancement thresholds, photostress recovery times
time frame: every three months

Eligibility Criteria

Male or female participants from 20 years up to 40 years old.

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

Additional Information

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
Principal investigator Billy R Hammond, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in August 2011.
Information provided to ClinicalTrials.gov by University of Georgia.