title: Long term effects of lutein, zeaxanthin and omega-3-LCPUFAs supplementation on optical density of macular pigment in AMD patients: the LUTEGA study.
abstract: BACKGROUND
  The primary objective of LUTEGA is to determine the long-term effect of a supplementation with fixed combination of lutein, zeaxanthin, omega-3-longchain-polyunsaturated-fatty-acids (O-3-LCPUFAs) and antioxidants on macular pigment optical density (MPOD) in patients with non-exudative age-related macular degeneration (AMD).
  
  
  METHODS
  The LUTEGA study is a double-blind, placebo-controlled clinical trial. 172 patients with non-exudative AMD were enrolled and randomized to three treatment arms. Supplementation included either once (dosage D1) or twice daily (dosage D2) of 10 mg L / 1 mg Z/ O-3-LCPUFAs (thereof 100 mg DHA, 30 mg EPA)/ antioxidants, or placebo (P). After best-corrected visual acuity (BCVA) test, blood sample was collected and MPOD was measured using the 1-wavelength-reflection method and recording reflection images at 480 nm (modified Visucam(NM/FA), Carl Zeiss Meditec, Germany). During 1 year of intervention, AMD patients were followed up after 1, 3, 6 and 12 months. 145 AMD patients (D1 = 50, D2 = 55, P = 40) completed the study.
  
  
  RESULTS
  After 12 months of intervention, the MPOD parameters (volume, area, maxOD, meanOD) increased significantly in treatment arms D1 and D2 (p < 0.001). Volume of MPOD showed the highest within-group difference and increased significantly in D1 and D2, and decreased significantly in P (p = 0.041). Between-group comparison of absolute changes of all MPOD parameters were significantly different between D1 and P as well as D2 and P with p < 0.001 at end point (t = 12). BCVA, measured in log MAR, improved in D1 and in D2 (p < 0.001). After 12 months of intervention, the mean improvement in BCVA was significant in D2 (p = 0.006) and D1 (p = 0.038) compared to P.
  
  
  CONCLUSIONS
  The supplementation of L, Z, O-3-LCPUFAs and antioxidants resulted in considerable increase in MPOD. There was no difference in accumulation of MPOD between both dosages. Thus, we believe that the used supplementation with L and Z seems to reach a saturation level in retinal cell structure. Additionally, the constant supplementation of L, Z, O-3-LCPUFAs and antioxidants in AMD patients seems to be useful, because MPOD reduces without supplementation. We conclude that the supplementation caused an increase of MPOD, which results in an improvement and stabilization in BCVA in AMD patients. Thus, a protective effect on the macula in AMD patients is assumed.
authors.affiliation: Department of Ophthalmology, University Hospital Leipzig, Liebigstrasse 10-14, 04103, Leipzig, Germany, jens.dawczynski@medizin.uni-leipzig.de.
authors.forename: Jens
authors.initials: J
authors.lastname: Dawczynski
authors.forename: Susanne
authors.initials: S
authors.lastname: Jentsch
authors.forename: Dietrich
authors.initials: D
authors.lastname: Schweitzer
authors.forename: Martin
authors.initials: M
authors.lastname: Hammer
authors.forename: Gabriele E
authors.initials: GE
authors.lastname: Lang
authors.forename: Jürgen
authors.initials: J
authors.lastname: Strobel
mesh_terms: D000368:Aged; D000975:Antioxidants / Q000008:administration & dosage; D001205:Ascorbic Acid / Q000008:administration & dosage; D019587:Dietary Supplements; D004311:Double-Blind Method; D004338:Drug Combinations; D015525:Fatty Acids, Omega-3 / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D057092:Geographic Atrophy / Q000175:diagnosis / Q000378:metabolism* / Q000503:physiopathology; D006801:Humans; D014975:Lutein / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012168:Retinal Pigments / Q000378:metabolism*; D014792:Visual Acuity / Q000502:physiology; D014810:Vitamin E / Q000008:administration & dosage; D024341:Xanthophylls / Q000008:administration & dosage*; D065146:Zeaxanthins; D017967:Zinc Compounds / Q000008:administration & dosage
chemical_list: D000975:Antioxidants; D004338:Drug Combinations; D015525:Fatty Acids, Omega-3; D012168:Retinal Pigments; D024341:Xanthophylls; D065146:Zeaxanthins; D017967:Zinc Compounds; D014810:Vitamin E; D001205:Ascorbic Acid; D014975:Lutein