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Randomized Controlled Trial
. 2020 Apr 6;10(1):5958.
doi: 10.1038/s41598-020-62483-0.

Effects of Lutein Supplementation in Japanese Patients with Unilateral Age-Related Macular Degeneration: The Sakai Lutein Study

Miki Sawa  1 , Takuya Shunto  2 , Issei Nishiyama  2 , Ayako Yokoyama  2 , Ryujiro Shigeta  3 , Satoko Miura  2 , Ryo Kawasaki  4
Affiliations
Randomized Controlled Trial

Effects of Lutein Supplementation in Japanese Patients with Unilateral Age-Related Macular Degeneration: The Sakai Lutein Study

Miki Sawa et al. Sci Rep. .

Abstract

This prospective randomized double-masked study investigated the effects of 20 mg lutein supplementation with two different capsules (beeswax or glycerol fatty acid esters) for 6 months on the fellow eyes of 39 Japanese patients with unilateral age-related macular degeneration, and assessed the factors associated with baseline plasma lutein concentration via lifestyle interviews. Macular pigment optical density (MPOD), determined with the two-wavelength autofluorescence method, increased over time in the beeswax group (ANOVA, p = 0.0451), although the increase from 3 months to 6 months was only marginally significant. No significant increase was observed in the glycerol fatty acid esters group (ANOVA, p = 0.7396). Plasma lutein concentrations significantly increased at 3 and 6 months from baseline in both groups (both p < 0.01). In a multiple regression model, age was negatively associated with higher plasma lutein concentration (p = 0.0305), while consumption of green vegetables was positively associated with baseline plasma lutein concentration (p = 0.0322). In conclusion, a significant increase in MPOD was not fully confirmed with 6 months intake duration despite a significant increase in plasma lutein concentrations. Consumption of green vegetable was confirmed to be associated with plasma lutein concentration after adjusting for other potential factors including age.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Figure 1
Figure 1
Changes in macular pigment optical density (MPOD) values in a total of 39 fellow eyes of unilateral age-related macular degeneration patients (A) and the beeswax capsule group (n = 20) and glycerol fatty acid esters capsule group (n = 19) (B). Comparison of MPOD difference from the baseline in the beeswax capsule group (n = 20) and glycerol fatty acid esters capsule group (n = 19) (C). (A) MPOD gradually increased from the baseline over 3 and 6 months without significance (repeated measures ANOVA, p = 0.0699). (B) In the beeswax capsule group, MPOD marginally increased from the baseline (ANOVA, p = 0.0451; Bonferroni corrected pair-wise comparison between 3 months and 6 months, p = 0.0555). MPOD in the glycerol fatty acid esters capsule group did not significantly increase from the baseline (repeated measures ANOVA, p = 0.7396). (C) No significant differences from the baseline were seen between the beeswax capsule and glycerol fatty acid esters capsule groups at 3 and 6 months (ANCOVA; p = 0.9722 and p = 0.2891, respectively). MPOD = macular pigment optical density; DU = density units; SE = standard error.
Figure 2
Figure 2
Changes in plasma lutein concentration in a total of 39 unilateral age-related macular degeneration patients (A) and the beeswax capsule group (n = 20) and glycerol fatty acid esters capsule group (n = 19) (B). Comparison of difference from the baseline in the beeswax capsule group (n = 20) and glycerol fatty acid esters capsule group (n = 19) (C). (A) Plasma lutein concentration significantly increased from the baseline at 3 months and 6 months (repeated measures ANOVA, p < 0.0001). (B) The plasma lutein concentrations significantly increased at 3 and 6 months from the baseline in the beeswax capsule group (repeated measures ANOVA, p < 0.0001) and at 6 months from the baseline in the glycerol fatty acid esters capsule group (repeated measures ANOVA, p = 0.0015). (C) No significant differences were seen between the two capsule groups at 3 and 6 months (ANCOVA; p = 0.0668 and p = 0.5171, respectively). SE = standard error.
Figure 3
Figure 3
Area under log contrast sensitivity function (AULCSF) changes in the contrast glare test under the glare background (A and B) and mesopic background (C and D) in a total of 39 unilateral age-related macular degeneration patients (A and C) and the beeswax capsule group (n = 20) and glycerol fatty acid esters capsule group  (n = 19) (B and D). AULCSF did not significantly increase from the baseline in the total population and in each capsule group. SE = standard error.
Figure 4
Figure 4
Scatter plot of age and baseline plasma lutein concentration. Baseline plasma lutein concentration = 333.41734 − 3.8749641 * age.
Figure 5
Figure 5
Composite figure demonstrating factors that decrease plasma lutein concentration. (A) Sex effects on baseline plasma lutein concentration. Baseline plasma lutein concentrations in males are lower than females (t-test, p = 0.0546). (B) AMD subtype in fellow eyes and baseline plasma lutein concentration. Baseline plasma lutein concentration in typical AMD patients was significantly lower than that in PCV patients (t-test, p = 0.0195). PCV = polypoidal choroidal vasculopathy. (C) Hypertension and baseline plasma lutein concentration. The plasma lutein concentration tended to differ in patients with or without hypertension. (t-test, p = 0.0520).
Figure 6
Figure 6
Smoking habit and baseline plasma lutein concentration. No significant difference was seen among the groups (ANOVA, p = 0.2581). The highest value in the current smoking group was lower than the mean value in the non-smoking and past smoking groups.
Figure 7
Figure 7
The frequency of green vegetable intake and baseline plasma lutein concentration. Score 0–2, equal to or less than one time in a week; score 3–4, 2–6 times in a week; score 5–6, at least one time in a day. A significant difference in baseline plasma lutein concentration was seen among the groups (ANOVA, p = 0.0445).
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