An assessment of clinical trials used in functional food science

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