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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. 13 No. 12 (2023): December 2023
				
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									Research Articles
							
		



	
		  	 

		
	
		Safety evaluation of high bioavailability curcumin in Healthy Japanese Adults: A Randomized, placebo-controlled, double-blind, parallel-group comparison study
	


	
	
		

							
					Authors

						
							
								Hyunjin Lee
							
															
									Theravalues Corporation
																	
																																		
	
							
								Yoshitaka Kuwabara
							
																																		
	
							
								Akiko Hirose
							
																																		
	
							
								Toshihiro Kakinuma
							
																																		
	
							
								Asami Baba
							
																																		
	
							
								Tsuyoshi Takara
							
																																		


				
			
																	
					
												DOI:
					

					
						
							https://doi.org/10.31989/ffhd.v13i12.1207
						
					
				
			

						
										
					Abstract

					Background:  Curcumin is the principal component responsible for the pharmacological action of Curcuma longa. It has been proven to exhibit a diverse range of functions. It has been used in many fields as a spice, coloring agent, cosmetic, and food preservative.
Objective: To evaluate the safety of the intake of highly bioavailable curcumin (CR-033P and TS-P1) in humans. 
Methods: We conducted two trials. The participants were healthy Japanese adults.  Participants of tria1 1 (Long-term intake trial) took CR-033P or TS-P1 for 12 weeks (as curcumin 150 mg/day). Participants of Trial 2 (Excessive intake trial) took TS-P1 for 4 weeks (as curcumin 750 mg/day).  The safety assessment involved monitoring the occurrence of side effects or adverse events, along with the analysis of urinalysis and blood parameters.
Results: The safety analysis population of Trial 1 included 33 participants in the CR-033P group, 32 participants TS-P1, and 30 participants in the Placebo group. The safety analysis population of trial 2 included 22 participants in TS-P1 and 20 participants in the Placebo group. In both Trial 1 and Trial 2, few participants were observed to experience adverse events and  however these were not adverse events related to the CR-033P or TS-P1. Results of urinalysis and blood analysis were confirmed to not exhibit medically problematic changes related to the CR-033P or TS-P1.
Conclusions: These trials proved the safety of the long-term intake of CR-033P or TS-PI- (as curcumin 150mg/ day) and the safety of the excessive intake of TS- P1 for four weeks (as curcumin 750mg/ day). TS-P1 and CR-033P can be considered a safe curcumin supplement based on these results.
     
Keywords: Curcumin, bioavailability, safety, high dose, long term dose, Healthy Japanese Adults, BMI, Blood pressure 
Trial registration: Trial 1: UMIN000046160, Trial 2: UMIN000048797. Foundation:Theravalues Corporation

				
			
			

						
																																																						
						
		


		

						
										
					
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																			2023-12-20
																	

				
							

			
						
										

											
							
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									Vol. 13 No. 12 (2023): December 2023
								
							

						
					
											
							
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								Research Articles
							

						
					
									

			
						
										
					
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