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							| Functional Foods in Health and Disease - Online ISSN: 2160-3855; Print ISSN: 2378-7007



	

				
						
 
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																Functional Foods in Health and Disease - Online ISSN: 2160-3855; Print ISSN: 2378-7007
										

				


				
				
					
					
						
																					
				
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					Vol. 15 No. 5 (2025): May 2025
				
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									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)

				
			
			

						
																																																						
						
		


		

						
										
					
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																			2025-05-14
																	

				
							

			
						
										

											
							
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									Vol. 15 No. 5 (2025): May 2025
								
							

						
					
											
							
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								Research Articles
							

						
					
									

			
						
										
					
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