Effects of Lutein and Zeaxanthin Supplementation on Early Age-related Macular Degeneration

• Changes of serum xanthophylls concentrations during the intervention [ Time Frame: at baseline and 4, 12, 24, 48, 96 weeks during the intervention ] [ Designated as safety issue: No ]
  changes of serum xanthophylls concentrations measured by high performance liquid chromatograph (HPLC)at baseline and 4, 12, 24, 48 and 96 weeks during the intervention
• Changes of best-spectacle corrected visual acuity (BSCVA) during the intervention [ Time Frame: at baseline and 24, 48, 96 weeks during the intervention ] [ Designated as safety issue: No ]
  best-spectacle corrected visual acuity (BSCVA) measured by ETDRS chart at baseline and 24, 48, 96 weeks during the intervention
• Changes of contrast sensitivity (CSF) measured by CSV-100 during the intervention [ Time Frame: at baseline, 24, 48 and 96 weeks during the intervention ] [ Designated as safety issue: No ]
• Changes of flash recovery time (FRT) measured by MDD-2 macular adaptometer [ Time Frame: at baseline, 24, 48 and 96 weeks during the intervention ] [ Designated as safety issue: No ]
  Flash recovery time (FRT) was measured by MDD-2 macular adaptometer at baseline, 24, 48 and 96 weeks
• Changes from baseline in multifocal electroretinogram (mfERG) at 48 weeks [ Time Frame: at baseline and 48 weeks during the intervention ] [ Designated as safety issue: No ]
• Changes from baseline in microperimetry (MP) in 96 weeks [ Time Frame: at baseline, 48 and 96 weeks during the intervention ] [ Designated as safety issue: No ]
  Microperimetry (MP) was measured by the MP1 Microperimeter
• Changes of food pattern at baseline, 48 and 96 weeks by food frequency questionnaire [ Time Frame: at baseline, 48 and 96 weeks ] [ Designated as safety issue: No ]

This study is to investigate the protective effects of supplemental lutein and zeaxanthin on early age-related macular degeneration (AMD) patients in China.

Early age-related macular degeneration (AMD) is an early hallmark of irreversible vision impairment accompanying with senescence of macular. Given the fact in treatment, prevention strategy is thought to be an efficient and robust approach to diminish early AMD patients in low-income countries, however, feasible cocktail provision in most developing nations remain mysteries. Here we proposed an effective cocktail treatment with different amounts of lutein and zeaxanthin could increase the macular pigment optical density (MPOD) and serum xanthophylls concentrations among randomized Chinese AMD patients; and might improve visual function measured by visual performance indices such as best-spectacle corrected visual acuity (BSCVA), contrast sensitivity (CSF), flash recovery time (FRT), multifocal electroretinogram (mfERG) and microperimetry.

• Dietary Supplement: placebo
  Placebo, one gelatine capsule containing starch per day, for 96 weeks
• Dietary Supplement: low lutein
  one gelatine capsule containing 10mg lutein per day, for 96 weeks
• Dietary Supplement: high lutein
  one gelatine capsule containing 20mg lutein per day, for 96 weeks
• Dietary Supplement: lutein plus zeaxanthin
  one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks
• Dietary Supplement: high zeaxanthin
  one gelatine capsule containing high zeaxanthin per day, for 48 weeks
• Dietary Supplement: zeaxanthin plus lutein
  one gelatine capsule containing a different portion of lutein and zeaxanthin compared with LZ per day, for 48 weeks

• Placebo Comparator: Placebo
  starch in hard shell gelatine capsules
  Intervention: Dietary Supplement: placebo
• Experimental: Low lutein
  low lutein group
  Intervention: Dietary Supplement: low lutein
• Experimental: High lutein
  high lutein group
  Intervention: Dietary Supplement: high lutein
• Experimental: Low lutein zeaxanthin
  lutein plus zeaxanthin group
  Intervention: Dietary Supplement: lutein plus zeaxanthin
• Experimental: High zeaxanthin
  zeaxanthin group
  Intervention: Dietary Supplement: high zeaxanthin
• Experimental: high lutein zeaxanthin
  Zeaxanthin plus lutein group
  Intervention: Dietary Supplement: zeaxanthin plus lutein

Inclusion Criteria:

• aged over 50 years, Chinese of the Han nationality
• diagnosed as age-related macular degeneration
• did not take lutein or zeaxanthin supplements in the past half a year
• good general health
• corrected visual acuity above 0.25 (20/80)
• did not take optical laser or medical treatments

Exclusion Criteria:

• had other ocular diseases, such as glaucoma, macular pucker, optic neuropathy, diabetic retinopathy etc.
• had nervous system diseases, stroke, Type I diabetes
• had diseases effected nutrients absorption, such as Crohn' s disease
• had turbid ocular media or transplanted intraocular lenses
• reported abnormal digestive condition