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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. 2 (2023): February 2023
				
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									Research Articles
							
		



	
		  	 

		
	
		An assessment of clinical trials used in functional food science
	


	
	
		

							
					Authors

						
							
								Samantha Marecek
							
															
									Functional Food Center Inc., Dallas, TX, USA; Cal Poly State University, San Luis Obispo, CA 93407, USA
																	
																																		
	
							
								Danik Martirosyan
							
															
									PhD, Functional Food Institute, Dallas, TX, United States
																	
																																		


				
			
																	
					
												DOI:
					

					
						
							https://doi.org/10.31989/ffhd.v13i2.1077
						
					
				
			

						
										
					Abstract

					Abstract: The emergence of chronic diseases with nutritional origin has rendered the wide use of clinical trials and intervention strategies necessary. Clinical trials have become a “gold standard” for testing the health impacts of different dietary changes; however, they also pose a potential risk to participants. Particularly with clinical trials used in food studies, there is an added complexity of food chemistry and food behavior as well as unique ethical issues related to clinical nutrition trials such as a potential violation of the right to be fed, disruption of food culture, and the need for food security. Thus, it becomes imperative to have a basic understanding of the key principles and methodology of different clinical trials to enable researchers to determine the best type of clinical trial for their functional food nutrition study. The progression of clinical nutrition trials is promising, but there is an increased importance of reviewing different models to determine the best method of performing nutrition-based research that minimizes the potential risk to participants while increasing current food knowledge. In this article, we aim to achieve two major goals: the first is analyzing various types of clinical trials and the second is using this analysis to figure out which type of clinical trial is ideally suited for research related to food and nutrition. 
Conclusion: We conclude that randomized trials are the most effective type of clinical trial used in functional food studies. Randomized cluster trials and randomized parallel-group trials are particularly effective in diminishing the challenges in functional food studies that are outlined in this paper as they reduce the effects one intervention has on another intervention.

Keywords: Clinical trials, Functional Food Science, Clinical research, Functional Food, Food, Nutrition

				
			
			

						
																										
						
		


		

						
										
					
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						Published
					

					
																			2023-02-17
																	

				
							

			
						
										

											
							
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									Vol. 13 No. 2 (2023): February 2023
								
							

						
					
											
							
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								Research Articles
							

						
					
									

			
						
										
					
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										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.

				

			
			

		

	




	




	


							



	

	

					
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