








































































Safety test of a supplement, 5-aminolevulinic acid phosphate with sodium  ferrous citrate, in diabetic patients treated with oral hypoglycemic agents
							| 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. 4 No. 9 (2014): September 2014
				
				/
			
	
			
									Research Articles
							
		



	
		  	 

		
	
		Safety test of a supplement, 5-aminolevulinic acid phosphate with sodium  ferrous citrate, in diabetic patients treated with oral hypoglycemic agents
	


	
	
		

							
					Authors

						
							
								Naohide Yamashita
							
															
									Department of Advanced Medical Science, Institute of Medical Science, The University of 
Tokyo, Tokyo, Japan;
																	
																																		
	
							
								Atai Watanabe
							
															
									Department of Advanced Medical Science, Institute of Medical Science, The University of 
Tokyo, Tokyo, Japan;
																	
																																		
	
							
								Hikaru Kondo
							
															
									SBI Pharmaceuticals Co., Ltd., Tokyo, Japan
																	
																																		
	
							
								Satofumi Kawata
							
															
									SBI Pharmaceuticals Co., Ltd., Tokyo, Japan
																	
																																		
	
							
								Tohru Tanaka
							
															
									SBI Pharmaceuticals Co., Ltd., Tokyo, Japan
																	
																																		
	
							
								Motowo Nakajima
							
															
									SBI Pharmaceuticals Co., Ltd., Tokyo, Japan
																	
																																		


				
			
																	
					
												DOI:
					

					
						
							https://doi.org/10.31989/ffhd.v4i9.151
						
					
				
			

						
										
					Abstract

					Objective: This study aimed to examine the safety of 5-aminolevulinic acid phosphate (5-ALA) with sodium ferrous citrate (SFC) in diabetic patients treated with one or more oral hypoglycemic agents (OHAs).
Background: Recent intervention studies performed in the USA and Japan have shown that a nutritional supplement of 5-ALA with SFC efficiently reduced blood glucose levels in pre-diabetic population without any adverse events. Thus, it was anticipated that 5-ALA with SFC may potentially be taken as a beneficial supplement by diabetic patients who were being treated with OHA therapy. Nevertheless, it is important to examine its safety and efficacy in diabetic population.
Methods: This study was a prospective single-blinded, randomized, placebo-controlled and parallel-group comparison study. Medically treated diabetic patients between the ages of 30 and 75 were recruited from the Tokyo metropolitan area of Japan and 45 subjects were selected after screening. These subjects were randomly assigned to three groups: daily intake of 15mg 5-ALA, 50mg 5-ALA, and a placebo (n=15, respectively). The supplement or placebo was administered for 12 weeks followed by a four week washout period. The primary endpoint was safety and  occurrence of hypoglycemic attack, while the secondary endpoint was changes of fasting blood glucose (FBG) and hemoglobin A1c (HbA1c). Results: Adverse events related to 5-ALA with SFC were not observed in all the groups. Abnormalities in blood and urine tests were not observed either. Significant decrease in FBG was not detected in all the groups. However, there was a small but significant decrease in HbA1c at 4 and 8 week in the 15 mg 5-ALA group. Significant decrease in HbA1c was not observed in the 50 mg 5-ALA group, although a tendency to decrease after 4 weeks was apparent.
Conclusion: 5-ALA with SFC is a safe and potentially beneficial supplement if taken by diabetic patients treated with OHAs.
Trial registration: UMIN 000008038
Key words: type 2 diabetes, 5-aminolevulinic acid (5-ALA), sodium ferrous citrate (SFC), oral hypoglycemic agent (OHA), hemoglobin A1c (HbA1c), fasting blood glucose (FBG)

				
			
			

						
																																																						
						
		


		

						
										
					
						Downloads
					

						
								
	
													


		
	[Abstract]

	
							
	
								
	
													


		
	[Full Article]

	
							


				

						
						
				
					
						Published
					

					
																			2014-09-13
																	

				
							

			
						
										

											
							
								Issue
							

							
								
									Vol. 4 No. 9 (2014): September 2014
								
							

						
					
											
							
								Section
							

							
								Research Articles
							

						
					
									

			
						
										
					
						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


	










