Safety and efficacy study of Lutein (VitaLutein®) in healthy Japanese adults: A randomized, placebo-controlled, double-blind, parallel-group comparative study | Functional Foods in Health and Disease - Online ISSN: 2160-3855; Print ISSN: 2378-7007 Skip to main content Skip to main navigation menu Skip to site footer Open Menu Functional Foods in Health and Disease - Online ISSN: 2160-3855; Print ISSN: 2378-7007 Home Food Science Publisher Functional Food Center Current Archives About About the Journal Aims and Scope Contact Editing Services Editorial Team Express Peer Review Graphical Abstract Journal Insights Privacy Statement Submissions Announcements Search Search Register Login Home / Archives / Vol. 15 No. 5 (2025): May 2025 / Research Articles Safety and efficacy study of Lutein (VitaLutein®) in healthy Japanese adults: A randomized, placebo-controlled, double-blind, parallel-group comparative study Authors Hyunjin Lee Takayuki Itano Faizal Mohamed Naoko Suzuki Tsuyoshi Takara Takahiro Yamada DOI: https://doi.org/10.31989/ffhd.v15i5.1605 Abstract Background: Lutein is a natural pigment with antioxidant properties found in both the eye's lens and macula. Daily exposure to certain wavelengths of light -- particularly blue and infrared – can increase the eyes' vulnerability to oxidative damage caused by free radicals. However, lutein’s antioxidant properties help protect cells from oxidative damage.  Objective: This study aimed to evaluate the reduction of oxidative stress in tears resulting from daily intake of VitaLutein®, within healthy Japanese adults. The safety of oral VitaLutein® intake was also assessed. Methods: A randomized, placebo-controlled, double-blind, parallel-group study was conducted. Thirty-one healthy Japanese adults were randomized to either the placebo or VitaLutein® group. Participants were enrolled based on levels of 8-hydroxydeoxyguanosine (8-OHdG) in their tears. Fifteen adults were assigned to the VitaLutein® group and sixteen to the placebo group. After 8-weeks, all subjects were evaluated for oxidative stress, macular pigment optical density, and dry eye symptoms. Safety assessments included urinalysis and blood tests. Results: No adverse events were attributed to the test food during the study period. Levels of 8-OHdG were significantly reduced at week 8 compared to baseline in the VitaLutein® group. Additionally, participants with prolonged Visual Display Terminal (VDT) use maintained higher Macular Pigment Optical Density (MPOD) levels compared to the placebo group. Novelty: This randomized controlled trial uniquely demonstrates the safety of VitaLutein® supplementation in healthy Japanese adults. This study provides preliminary evidence suggesting its potential to reduce tear oxidative stress (8-OHdG) and maintain macular pigment optical density (MPOD), particularly in individuals with prolonged extended VDT usage. Conclusions: These results suggest that continuous ingestion of VitaLutein® supplements may reduce oxidative stress and maintain macular pigment. The product has also been proven safe in adult, human subjects.  Keywords: VitaLutein®, Oxidative Stress, 8-hydroxy-2-deoxyguanosine(8-OHdG), Visual Display Terminal (VDT), macular pigment density (MPOD).(UMIN ID: UMIN000014590) Downloads [Abstract] [Full Article] Published 2025-05-14 Issue Vol. 15 No. 5 (2025): May 2025 Section Research Articles License Copyright (c) 2025 Functional Foods in Health and Disease This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. Authors retain the copyright of their articles and grant the Functional Food Center (FFC) and its journals the right of first publication under the terms of the Creative Commons Attribution 4.0 International License. This license permits unrestricted use, distribution, and reproduction in any medium, including commercial use, provided the original author(s) and source are properly credited. Authors may post and share their published work freely, provided that the original publication in this journal is acknowledged. By submitting to this journal, authors confirm that their manuscripts are original, not under consideration elsewhere, and that they hold the necessary rights to grant this license. The Functional Food Center encourages open scientific exchange and allows derivative and extended works, provided attribution to the original publication is maintained. About the Journal      Editing Services      Graphical Abstract      Journal Insights        Submissions        Editorial Team       Privacy Statement        Contact        Current        Archives   Open Journal Systems Hosting and Support by: OpenJournalSystems.com