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Clinical Trials |

Macular Xanthophylls and ω-3 Long-Chain Polyunsaturated Fatty Acids in Age-Related Macular Degeneration:  A Randomized Trial

Christin Arnold, Dipl-Troph; Lisa Winter, Dipl-Troph; Kati Fröhlich, PhD; Susanne Jentsch, Dipl-Ing; Jens Dawczynski, MD; Gerhard Jahreis, PhD; Volker Böhm, PhD
JAMA Ophthalmol. 2013;131(5):564-572. doi:10.1001/jamaophthalmol.2013.2851.
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Importance It has been shown that the functionality of the macula lutea depends on the nutritional uptake of lutein and zeaxanthin and that it is inversely associated with the risk of age-related macular degeneration (AMD). Additionally, ω-3 long-chain polyunsaturated fatty acids (LC-PUFAs) may also be protective.

Objective To investigate the effect of a 12-month intervention with macular xanthophylls and ω-3 LC-PUFAs on xanthophylls and fatty acids in plasma, antioxidant capacity, and optical density of the macular pigment of patients with nonexudative AMD.

Design The LUTEGA study was a randomized, double-blind, placebo-controlled, parallel clinical trial that was conducted for 12 months.

Setting University Eye Hospital and Institute of Nutrition, Friedrich Schiller University Jena, Germany.

Participants A total of 172 individuals with nonexudative AMD.

Intervention Individuals were enrolled and randomly divided as follows: placebo group, group 1 (a capsule containing 10 mg of lutein, 1 mg of zeaxanthin, 100 mg of docosahexaenoic acid, and 30 mg of eicosapentaenoic acid administered each day), and group 2 (same substances but twice the dose used in group 1). One hundred forty-five participants completed the study successfully.

Main Outcome Measures Plasma xanthophyll concentrations and fatty acid profiles, optical density of the macular pigment, and antioxidant capacity in plasma (6-hydroxy-2,5,7,8-tetramethylchroman-2-carboxylic acid [Trolox] equivalent antioxidant capacity and photochemiluminescence).

Results The concentrations of the administered carotenoids in plasma as well as the optical density of the macular pigment increased significantly in the groups randomized to receive supplementary macular xanthophylls and ω-3 LC-PUFAs after 1 month of intervention and remained at this level through the end of the study. Use of the double dose resulted in a beneficial alteration of the fatty acid profile in the plasma of patients with AMD in comparison with the dose in group 1. The lipophilic antioxidant capacity in plasma was significantly elevated with the intervention.

Conclusions and Relevance A supplement containing a fixed combination of lutein, zeaxanthin, and ω-3 LC-PUFAs during 12 months significantly improved plasma antioxidant capacity, circulating macular xanthophyll levels, and the optical density of the macular pigment.

Trial Registration clinicaltrials.gov Identifier: NCT00763659

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Figure 1. Number of participants per group and reasons for withdrawal. AMD indicates age-related macular degeneration.

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Figure 2. Concentrations of lutein in plasma at baseline (0) and at study's end (12 months) within the study groups. *Significant differences (P < .05, paired t test, natural logarithm-transformed values). The box and whisker plots show the 25th and 75th percentiles, the median (rule within the box), and the 10th and 90th percentiles (whiskers); outliers are symbolized by the circles.

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Figure 3. Alteration of the concentrations of lutein and zeaxanthin in the plasma of patients with age-related macular degeneration during a 12-month study. Values are mean (SD). *Significant differences within the groups in relationship to baseline (0), (P < .05, general linear model procedure [repeated measurements], natural log–transformed values).

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Figure 4. Alteration of the lipophilic antioxidant capacity in plasma during 12 months of intervention. *Significant differences within the groups in relation to baseline (0) (P < .05, general linear model; repeated measurements). Trolox indicates 6-hydroxy-2,5,7,8-tetramethylchroman-2-carboxylic acid.

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Figure 5. Alterations of the optical density of the macular pigment in patients with age-related macular degeneration during the study. Values are mean (SD). *Significant differences within the groups in relation to baseline (0) (P < .05, general linear model procedure; repeated measurements).

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