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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. 11 (2022): November 2022
				
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									Research Articles
							
		



	
		  	 

		
	
		Effectiveness in the short-term of a novel nutraceutical for the management of hypercholesterolemia: an observational multicenter primary care experience
	


	
	
		

							
					Authors

						
							
								Francesco Natale
							
																																		
	
							
								Riccardo Molinari
							
																																		
	
							
								Simona Covino
							
																																		
	
							
								Gaetano Piccinocchi
							
																																		
	
							
								Andrea Salvetti
							
																																		
	
							
								Emanuele Monda
							
																																		
	
							
								Giuseppe Limongelli
							
																																		
	
							
								Giovanni Cimmino
							
																																		


				
			
																	
					
												DOI:
					

					
						
							https://doi.org/10.31989/ffhd.v12i11.1023
						
					
				
			

						
										
					Abstract

					Purpose: Increasing evidence reinforces the benefits of reduction of low-density lipoprotein (LDL-C) levels on cardiovascular outcomes. Different targets are suggested based on cardiovascular risk (CVR). According to the current European guidelines, a goal of LDL-C≤ 115mg/dL is desirable for patients with low-moderate CVR. However, a high percentage of these patients are far from this target. Nutraceuticals are “food supplements” that may help to achieve this goal in this population. In this retrospective analysis, we evaluate the effects of dietary supplementation with a novel monacolin/berberine/bergamot nutraceutical formulation on plasma lipid levels of subjects with low-moderate hypercholesterolemia who are not treated with conventional drug or other dietary supplements. 
Patients and Methods:526 adult patients with hypercholesterolemia were retrospectively selected from the database of participant family practitioners according to prespecified criteria. All selected patients had a baseline and 30-day value of total cholesterol (TC), LDL-C, high-density lipoprotein cholesterol, triglycerides, C-reactive protein, and transaminases and have started a dietary supplementation with this novel nutraceutical. Similarly, 104 subjects with comparable clinical features but not treated with any supplements were also selected. 
Results:At 30-day, the administration of nutraceuticals was associated with a significant reduction of LDL-C (124 ± 14 vs. 100 ± 13 mg/dL, Δ 24.5mg, p-value <0.0001) and TC levels (210 ± 56 vs. 187 ± 60, p-value < 0.0001), in the absence of a significant change of transaminase levels. No side effects were reported in the database during the observation period. 
Conclusion: This novel nutraceutical is an effective dietary supplement to achieve a significant and early  LDL-C reduction in patients with hypercholesterolemia at low-moderate CVR.

Keywords:Cardiovascular Risk; Hypercholesterolemia; Nutraceuticals

				
			
			

						
																																																																				
						
		


		

						
										
					
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																			2022-11-17
																	

				
							

			
						
										

											
							
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									Vol. 12 No. 11 (2022): November 2022
								
							

						
					
											
							
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								Research Articles
							

						
					
									

			
						
										
					
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