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

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)