OBJECTIVE: This randomized controlled trial examined serum and macular (in vivo measured macular pigment optical density [MPOD]) responses to supplemental lutein and zeaxanthin in Chinese subjects with early age-related macular degeneration. METHODS:One hundred and eight patients with early age-related macular degeneration older than 50 y were randomized to low lutein (LL; 10 mg/d), high lutein (HL; 20 mg/d), lutein plus zeaxanthin (LZ; each 10 mg/d), or placebo during a 48-wk intervention. Serum concentrations were quantified by C(30) high-performance liquid chromatography (at baseline and 4, 12, 24, and 48 wk), and MPOD was measured by analysis of autofluorescence images (at baseline and 24 and 48 wk). RESULTS:Serum lutein levels in the LL, LZ, and HL groups increased significantly in the first 4 wk and then increased 4.24-, 4.66-, and 6.23-fold during the trial, respectively (all P < 0.001). The serum lutein level in the HL group was significantly higher than that in the LL or LZ group at 48 wk (P < 0.05). Similarly, the serum zeaxanthin concentration in the LZ group increased 3.11-fold at 48 wk. MPOD increased smoothly in all treated groups, and the increase from baseline was greatest in the HL group at 24 and 48 wk (both P < 0.05). MPOD and serum lutein levels increased linearly with the dosage and their increasing rates were statistically correlated (all P < 0.05). No notable changes were detected in the placebo group for MPOD and serum concentrations. CONCLUSION:Xanthophyll supplementation significantly increased serum concentrations and MPOD in patients with early age-related macular degeneration, and a higher lutein supplementation (20 mg/d) might be more effective in increasing these two biochemical markers in Chinese patients without significant side effects.
RCT Entities:
OBJECTIVE: This randomized controlled trial examined serum and macular (in vivo measured macular pigment optical density [MPOD]) responses to supplemental lutein and zeaxanthin in Chinese subjects with early age-related macular degeneration. METHODS: One hundred and eight patients with early age-related macular degeneration older than 50 y were randomized to low lutein (LL; 10 mg/d), high lutein (HL; 20 mg/d), lutein plus zeaxanthin (LZ; each 10 mg/d), or placebo during a 48-wk intervention. Serum concentrations were quantified by C(30) high-performance liquid chromatography (at baseline and 4, 12, 24, and 48 wk), and MPOD was measured by analysis of autofluorescence images (at baseline and 24 and 48 wk). RESULTS: Serum lutein levels in the LL, LZ, and HL groups increased significantly in the first 4 wk and then increased 4.24-, 4.66-, and 6.23-fold during the trial, respectively (all P < 0.001). The serum lutein level in the HL group was significantly higher than that in the LL or LZ group at 48 wk (P < 0.05). Similarly, the serum zeaxanthin concentration in the LZ group increased 3.11-fold at 48 wk. MPOD increased smoothly in all treated groups, and the increase from baseline was greatest in the HL group at 24 and 48 wk (both P < 0.05). MPOD and serum lutein levels increased linearly with the dosage and their increasing rates were statistically correlated (all P < 0.05). No notable changes were detected in the placebo group for MPOD and serum concentrations. CONCLUSION:Xanthophyll supplementation significantly increased serum concentrations and MPOD in patients with early age-related macular degeneration, and a higher lutein supplementation (20 mg/d) might be more effective in increasing these two biochemical markers in Chinese patients without significant side effects.
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