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Randomized Controlled Trial
. 2024 Dec 18;16(24):4366.
doi: 10.3390/nu16244366.

Effect of Dietary Supplementation with Lutein, Zeaxanthin, and Elderberries on Dry Eye Disease (DED) and Immunity: A Randomized Controlled Trial

Kok Ming Goh  1   2 , Eugenie Sin Sing Tan  3 , Crystale Siew Ying Lim  4 , Pui Yee Tan  5 , Sayantan Biswas  6 , Li Ann Lew  2   7 , Chung Keat Tan  3
Affiliations
Randomized Controlled Trial

Effect of Dietary Supplementation with Lutein, Zeaxanthin, and Elderberries on Dry Eye Disease (DED) and Immunity: A Randomized Controlled Trial

Kok Ming Goh et al. Nutrients. .

Abstract

Background/objectives: Dry eye disease (DED) significantly impairs quality of life, affecting physical, social, and psychological well-being, as well as reducing workplace productivity. While lutein and zeaxanthin supplements have been shown to improve ocular health, existing research often overlooks the efficacy of lower dosages and shorter durations of supplementation. This study investigated the effects of combined supplementation with lutein, zeaxanthin, and elderberries in 110 voluntary participants through a randomized controlled trial.

Methods: Participants took 6 mg of lutein and 1 mg of zeaxanthin, along with 100 mg elderberry extract once daily for a duration of 20 days. Ocular health was assessed using the Ocular Surface Disease Index (OSDI), while immune status was evaluated with the Immune Status Questionnaire (ISQ).

Results: Results showed that combined supplementation significantly (p < 0.05) reduced the OSDI scores in the intervention group from 38.15 ± 11.14 to 18.26 ± 5.57, reflecting a 52.2% reduction. A similar trend was observed with the Visual Analog Scale (VAS), indicating significant (p < 0.05) improvement from 5.31 ± 1.62 to 6.73 ± 1.74, equivalent to a 26.7% improvement. Although the intervention group showed a 15.9% improvement in ISQ scores by the study's end, this was not significantly different from the placebo group, suggesting that higher dosages or longer durations may be needed to observe a meaningful effect. Additionally, findings from the Food Frequency Questionnaire revealed that the average dietary intake of lutein and zeaxanthin among participants was only 663.49 µg, equating to just 5.5% of the suggested optimal daily intake. This low consumption is concerning, as it is inversely correlated with the risk of ocular diseases.

Conclusions: Collectively, these findings support the use of combined supplementation as an adjuvant approach to improving ocular health.

Keywords: Immune Status Questionnaire (ISQ); Ocular Surface Disease Index (OSDI); elderberries; lutein; zeaxanthin.

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Conflict of interest statement

Author Kok Ming Goh was employed by the company Ecolite Biotech Manufacturing. Authors Kok Ming Goh and Li Ann Lew were employed by the company Xmegami Manufacturing. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
CONSORT protocol for the study described with flow diagram.
See this image and copyright information in PMC

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