Clinical Effects of Dietary Supplementation of Lutein with High Bio-Accessibility on Macular Pigment Optical Density and Contrast Sensitivity: A Randomized Double-Blind Placebo-Controlled Parallel-Group Comparison Trial
What this study found
Daily 12 mg lutein for 16 weeks produced a favorable overall effect: macular pigment optical density increased and visual function improved versus placebo. At week 16, MPOD was 0.545±0.173 in the lutein group versus 0.523±0.159 in placebo (p=0.040). Serum lutein rose markedly by week 8 and remained higher at week 16, with 0.836±0.446 versus 0.407±0.187 at week 8 and 0.751±0.473 versus 0.391±0.175 at week 16 (both p<0.001). Contrast sensitivity and glare sensitivity were also better at week 16, with reported p-values of 0.0012, 0.047, 0.014, and 0.020 for the measured visual outcomes. No…
- Study & population
- Randomized, double-blind, placebo-controlled parallel-group trial in healthy adult men and women aged 20 to 69 years in Japan.
- Intervention
- The active regimen was oral lutein, 12 mg/day for 16 weeks, taken as two soft capsules once daily after breakfast or lunch.
- Key limitation
- The trial was relatively small and short, which limits precision and long-term inference.
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Open PDFOriginal abstract
Improvements in macular pigment optical density (MPOD) and contrast sensitivity after administration of 12 mg lutein alone and the timing at which efficacy is observed remain unknown. Therefore, lutein (12 mg), a crystalline formulation, was used in this study, considering its bioaccessibility. This study aimed to determine the effects of lutein administration for 16 weeks on MPOD, contrast sensitivity, and glare sensitivity, and changes in serum lutein levels were determined. The study subjects comprised 59 healthy male and female adults aged 20–69 years. The study diet included a placebo (placebo group) or a diet supplemented with 12 mg of lutein (lutein group). Each study diet was continuously administered for 16 weeks. At weeks 8 and 16, MPOD, contrast sensitivity, glare sensitivity, and serum lutein levels were evaluated. Compared with the placebo group, the lutein group showed significantly improved MPOD, contrast sensitivity, and glare sensitivity at week 16 and significantly increased serum lutein levels at weeks 8 and 16. Continuous administration of lutein for 16 weeks, considering its bioaccessibility, increased MPOD; it made the outlines of visible objects clearer and was effective in inhibiting decreases in visual function caused by glare from light.