Safety study of Lutein (VitaLutein®) in healthy Japanese adults: A randomized, placebo-controlled, double-blind, parallel-group comparative study

Background Lutein is a natural pigment with antioxidant properties, present in the eye's lens and macula. Daily exposure to light—particularly blue and infrared wavelengths—increases the eyes' vulnerability to oxidative damage caused by free radicals. However, lutein’s antioxidant effect helps protect against this damage, even when visual cells are at risk of severe light-induced harm. Objective The aim of this study is to evaluate the reduction of the oxidative stress in the tear, due to the daily intake of VitaLutein®, in healthy Japanese adults and to evaluate the safety of oral intake of VitaLutein®. Methods We conducted a randomized, placebo-controlled, double-blind, parallel-group study. Thirty-one healthy Japanese adults were randomized to the placebo or VitaLutein® group. The participants were enrolled upon screening for person with relatively large value of 8-hydroxydeoxyguanosine (8-OHdG) in the tear: fifteen of them were assigned to a VitaLutein® group and sixteen to a placebo group and evaluated for the degree of oxidative stress, macular pigment optical density and dry eye evaluation after 8-week of ingestion period. Results There were no adverse events attributed to the test foods during the study period. The 8-OHdG at week 8 from baseline showed a significantly reduction in the VitaLutein® group. In addition, the group with long VDT work hours maintained higher Macular Pigment Optical Density (MPOD) than the placebo group. Conclusions These results suggest that continuous ingestion of VitaLutein® supplements could be involved in the reduction of oxidative stress and maintenance of macular pigment and also is safe. Key word: VitaLutein®, Oxidative Stress, 8-hydroxy-2-deoxyguanosine(8-OHdG), VDT, macular pigment density (MPOD). (UMIN ID: UMIN000014590)