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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. 12 No. 8 (2022): August 2022
				
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									Research Articles
							
		



	
		  	 

		
	
		A randomized, controlled trial on the effectiveness of a proprietary marine lipo-peptide formula vs omega-3 on cytokines profile, anxiety, and pain symptoms in patients with fibromyalgia
	


	
	
		

							
					Authors

						
							
								Reza Rastmanesh
							
															
									The Nutrition Society, London, UK
																	
																																		
	
							
								Umberto Solimene
							
															
									WHO-collaborating Center for WHO-cntr forTraditional Medicine & Biotechnology, University of Milano, Milano, Italy
																	
																																		
	
							
								Aldo Lorenzetti
							
															
									Senior researcher, Regenera Intl. Aging Intervention
																	
																																		
	
							
								Francesco Marotta
							
															
									ReGenera R&D International for Aging Intervention, Milano, Italy
																	
																																		
	
							
								HE Fang
							
															
									Department of Nutrition and Food hygiene, West China School of Public Health and West China Fourth Hospital, Sichuan University,  Sichuan China
																	
																																		
	
							
								Cristiana Aperio
							
															
									Senior researcher, Regenera Intl. Aging Intervention
																	
																																		
	
							
								Nevenka Anzulovic
							
															
									Senior researcher, Regenera Intl. Aging Intervention
																	
																																		
	
							
								Giuseppe Cervi
							
															
									ReGenera R&D International for Aging Intervention, Italy
																	
																																		
	
							
								Nicola Zerbinati
							
															
									Department of Medicine and Surgery, University of Insubria, Varese, Italy.
																	
																																		


				
			
																	
					
												DOI:
					

					
						
							https://doi.org/10.31989/ffhd.v12i8.954
						
					
				
			

						
										
					Abstract

					Objective: The aim of the present study in an RCT manner (physicians and patients) a novel lipo-peptide marine compound, LD-1227, on physical-, emotional- and functional-related symptomatic complaints in fibromyalgia patients as well as inflammatory cytokines profile and gene expression while using omega-3 as a control group.
Methods: The following questionnaire-based or clinical evaluation-based parameters were evaluated: widespread pain index [WPI] patient global impression of change, total tender points [TTP], fibromyalgia impact questionnaire, Beck depression inventory, fatigue severity ratings, cognitive symptom severity, symptom severity score [SSS] and weekly pain intensity ratings. Additional biochemical and gene expression analysis of cytokines (IL6, TNF-α, IL-1β, MCP-1, IL-8, IL-13, IL-1α, and GM-CSF) was performed as well. Data were analyzed with either a paired t-test or the Wilcoxon signed rank test depending on the parametric or non-parametric distribution.
Results: Comparing the data from before and after treatment for Group B indicated a statistically significant reduction (p=0.05) in TTP, WPI score, and SSS score. These data suggest a positive effect of a 3-month treatment with the LD-1227 but not omega-3 treatment on Fibromyalgia pain and related anxiety/depressive symptoms. Inspections of HRV and Cytokines found a statistically significant improvement after LD1227 treatment. Unlike the group supplemented with omega-3, the treatment with LD-1227 brought about a decrease in WPI and weekly pain intensity symptoms for the majority of participants. The pre-and post-treatment data for Group B indicated a statistically significant reduction (p=0.05) in TPC, WPI, and SSS scores. No adverse events were reported.
Conclusion: These results provide the first indications that the LD-1227 treatment has a statistically significant effect on the recognized fibromyalgia diagnosis metrics of WPI, TTP, and SSS as well on inflammatory markers and parasympathetic balance.

Keywords: fibromyalgia, marine compound, lipopeptide, cytokines, anxiety, pain, LD-1227.

				
			
			

						
																																																																											
						
		


		

						
										
					
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						Published
					

					
																			2022-08-26
																	

				
							

			
						
										

											
							
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									Vol. 12 No. 8 (2022): August 2022
								
							

						
					
											
							
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								Research Articles
							

						
					
									

			
						
										
					
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