Response to supplementation with lutein and zeaxanthin in subjects with familial history of AMD: the LIMPIA Study

Abstract

Purpose: To assess the effect of nutritional supplementation on plasma lutein and zeaxanthin in healthy subjects with familial history of AMD.

Methods: The Limpia Study is a randomized clinical trial performed in 120 healthy subjects aged 40-70 years with at least one parent affected by neovascular AMD. Included subjects were randomly assigned to receive Nutrof® Total (2 gels/day, representing lutein 10 mg/day, zeaxanthin 2 mg/day, long chain omega 3 fatty acids 540 mg/day, vitamin C 180 mg/day, vitamin E 30 mg/day, zinc 15 mg/day, copper 1 mg/day and resveratrol 1 mg/day) or placebo for 6 months, and were subsequently followed for 6 additional months after the end of supplementation. Plasma lutein and zeaxanthin were measured by normal-phase HPLC, from fasting blood samples.

Results: Baseline plasma lutein concentrations were 0.38 µmol/l ± 0.15 in the supplemented group and 0.37 µmol/l ± 0.16 in the placebo group. It increased in the supplemented subjects during the supplementation period (change from baseline +0.58 µmol/l ± 0.41 in the supplemented group and -0.02 µmol/l ± 0.09 in the placebo group at 3 months, p<0.0001 and +0.59 µmol/l ± 0.39 versus -0.04 ±0.12 at 6 months, p<0.0001). Three months after the end of supplementation, the supplemented group was still different from placebo (change from baseline +0.02± 0.10 versus -0.02 ± 0.12, p=0.03), but this difference between groups was no longer significant at 6 months (+0.01± 0.10 versus -0.02 ± 0.11, p=0.09). Baseline plasma zeaxanthin concentrations were 0.08 µmol/l ± 0.04 in the supplemented group and 0.09 ± 0.04 in the placebo group. It increased in the supplemented subjects during the supplementation period (change from baseline +0.14 ± 0.09 versus -0.01± 0.03, p<0.0001 at 3 months and +0.14 ± 0.09 versus -0.01± 0.03, p<0.0001 at 6 months), and, remained slightly higher after the end of supplementation (+0.01 ± 0.04 versus -0.01± 0.03, p=0.002, 3 months after the end of supplementation and +0.01 ± 0.03 versus -0.01± 0.03, p=0.003, 6 months after the end of supplementation).

Conclusions: This study documents an increase of more than 150% in plasma L and Z with Nutrof supplementation, in subjects at high genetic risk for AMD. A minimal difference in plasma L and Z between supplemented and placebo groups persisted several months after the end of supplementation.

Keywords: 412 age-related macular degeneration • 618 nutritional factors • 444 carotenoids/carotenoid binding proteins