The LIMPIA Study: A randomized trial of supplementation with lutein, zeaxanthin, omega 3 fatty acids and antioxidants for increasing macular pigment optical density in high-risk subjects for exudative AMD.

Abstract

Purpose: We performed a prospective randomized clinical trial testing the efficacy of a dietary supplement containing lutein, zeaxanthin, omega 3 fatty acids and antioxidants for increasing macular pigment density.

Methods: The Limpia Study is a double-blind, placebo-controlled, prospective randomized clinical trial performed in 120 subjects with at least one parent affected by neovascular AMD. Subjects were treated with placebo or active treatment during 6 months, and followed 6 months after the end of the treatment. The primary outcome was the variation of macular pigment optical density measured every 3 months during one year using two different techniques [modified HRA (Heidelberg) and Visucam 200 MPD (Carl Zeiss Meditec)].

Results: 120 subjects were included from January 2011 to January 2012 in 2 centers (Bordeaux and Dijon, France). Mean age was 56.7 years and 71.7 % were women. The mother of 97 subjects (80.8 %) was affected by AMD, while in only 25 subjects (20.8 %) the father was affected. Blood samples were collected and confirmed the increase of plasma carotenoids after 3 and 6 months of follow-up in the supplemented group, as compared to the placebo group. However, macular pigment measurements realized either using modified HRA (Heidelberg) or Visucam 200 MPD (Carl Zeiss Meditec) did not demonstrate any significant modifications in macular pigment optical density in the treated group as compared to the placebo group at any time of the study.

Conclusions: The LIMPIA randomized prospective clinical trial demonstrated an increase in plasma concentrations of both lutein and zeaxanthin after oral supplementation. However, it did not disclose any significant modification of macular pigment density after 6 months of oral supplementation in subjects with at least one parent affected by neovascular AMD. This can be explained either by defective carotenoid macular concentration in this high risk population for AMD and/or technical issues of the two quantification methods choosen for macular pigment measurments.<br />