METHODS. Subjects consumed daily a formulation containing 10 mg L, 2 mg Z, and 10 mg MZ (active group; n ¼ 53) or placebo (n ¼ 52) for a period of 12 months. Study visits were at baseline, 3, 6, and 12 months. Contrast sensitivity at 6 cycles per degree (cpd) was the primary outcome measure (POM). Secondary outcome measures included CS at other spatial frequencies, best-corrected visual acuity (BCVA), glare disability, photostress recovery, and light scatter. Macular pigment optical density (MPOD) was measured using dual-wavelength autofluorescence, and serum carotenoid concentrations were analyzed using high performance liquid chromatography (HPLC).RESULTS. Compared to placebo, statistically significant improvements from baseline CS were detected at 6 (P ¼ 0.002) and 1.2 (P ¼ 0.004) cpd in the active group. Additionally, improvements in CS were commensurate with the observed increases in retinal concentrations of these carotenoids (r ¼ 0.342, P ¼ 0.002 at 6 cpd).
CONCLUSIONS.These results indicate that dietary fortification with the macular carotenoids can have meaningful effects on visual function.