




































































Safety evaluation of excessive intake of Hesperetin-7-Glucoside-β-Cyclodextrin Inclusion Complex in Healthy Japanese Subjects
							| 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. 14 No. 3 (2024): March 2024
				
				/
			
	
			
									Research Articles
							
		



	
		  	 

		
	
		Safety evaluation of excessive intake of Hesperetin-7-Glucoside-β-Cyclodextrin Inclusion Complex in Healthy Japanese Subjects
	


	
	
		

							
					Authors

						
							
								Masamitsu Moriwaki
							
															
									TAIYOKAGAKU Co.,LTD
																	
																																		
	
							
								Aya Abe
							
															
									TAIYOKAGAKU Co.,LTD
																	
																																		
	
							
								Mahendra P Kapoor
							
															
									TAIYOKAGAKU Co.,LTD
																	
																																		
	
							
								Akiko Yamaguchi
							
															
									TAIYOKAGAKU Co.,LTD
																	
																																		
	
							
								Saki Okamoto
							
															
									TAIYOKAGAKU Co.,LTD
																	
																																		
	
							
								Makoto Ozeki
							
															
									TAIYOKAGAKU Co.,LTD
																	
																																		


				
			
																	
					
												DOI:
					

					
						
							https://doi.org/10.31989/ffhd.v14i3.1325
						
					
				
			

						
										
					Abstract

					Background: Hesperidin, a flavonoid glycoside, is widely found in the peels and rinds of citrus fruits, offering various physiological benefits. However, its effectiveness is hindered by challenges related to insolubility and low bioavailability. To overcome these obstacles, we developed the Hesperetin-7-glucoside -β-cyclodextrin inclusion complex (HCD). This complex demonstrates superior solubility and bioavailability compared to hesperidin. In a previous study where participants consumed 300 mg/day of HCD for 12 weeks, there was a notable improvement in endothelial dysfunction. Importantly, no significant adverse clinical events were reported during this period.

Objective: To evaluate the safety of the excessive intake of HCD in Healthy Japanese subjects.

Methods: Fourteen healthy male and female volunteers (with a mean age of 39.1±9.1) participated in this excessive HCD intake clinical trial. Subjects took 1500 mg/day HCD, which was five times the dosage of 300 mg/day HCD, for 4 consecutive weeks. Physical examination, blood tests, and uric tests were performed during this period.

Results: Results demonstrated no significant differences at 2, and 4 weeks compared to the baseline at 0 weeks with 1500 mg HCD (equivalent to 195 mg HPTG) supplementation in healthy subjects.

Conclusions: It has been demonstrated that there are no safety concerns when consuming 1500 mg of HCD daily, continuously for 4 weeks.

Keywords: Safety, Bioavailability, Clinical trials, Hesperidin, Food, Foods with Function Claims, Overdose supplementation, Cyclodextrin

Trial registration: UMIN-CTR (Trial ID: UMIN000051960)

Foundation: Taiyo Kagaku Co. Ltd.

				
			
			

						
																																																						
						
		


		

						
										
					
						Downloads
					

						
								
	
													


		
	[Abstract]

	
							
	
								
	
													


		
	[Full Article]

	
							


				

						
						
				
					
						Published
					

					
																			2024-03-04
																	

				
							

			
						
										

											
							
								Issue
							

							
								
									Vol. 14 No. 3 (2024): March 2024
								
							

						
					
											
							
								Section
							

							
								Research Articles
							

						
					
									

			
						
										
					
						License
					

																										Copyright (c) 2024 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


	










