Clinical trials using functional foods provide unique challenges

Brown, Lindsay and Caligiuri, Stephanie P. B. and Brown, Dan and Pierce, Grant N. (2018) Clinical trials using functional foods provide unique challenges. Journal of Functional Foods, 45. pp. 233-238. ISSN 1756-4646


Clinical trials usually evaluate medicines as the intervention of choice to improve health. Changing the intervention to a functional food would appear straightforward, but there are many unique technical issues that will confront the Principal Investigator and research team. These challenges are found in each of the three distinct phases of a trial: the initial organisation of the trial, running the trial, and finally, the dissemination of the data following successful completion of the trial. Each challenge presents very different issues that will limit the conclusions of the trial unless addressed properly. We suggest that careful planning of the trial taking into consideration thirteen important technical parameters can ensure that the data are relevant and lead to reliable conclusions, every bit as valuable as those obtained in trials with medicines.

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Item Type: Article (Commonwealth Reporting Category C)
Refereed: Yes
Item Status: Live Archive
Additional Information: Restricted access to published version in accordance with the copyright policy of the publisher.
Faculty/School / Institute/Centre: Current - Faculty of Health, Engineering and Sciences - School of Health and Wellbeing
Date Deposited: 21 May 2018 04:23
Last Modified: 29 May 2018 00:57
Uncontrolled Keywords: clinical trial, functional food, natural health products, health food
Fields of Research : 11 Medical and Health Sciences > 1111 Nutrition and Dietetics > 111103 Nutritional Physiology
11 Medical and Health Sciences > 1115 Pharmacology and Pharmaceutical Sciences > 111501 Basic Pharmacology
Socio-Economic Objective: E Expanding Knowledge > 97 Expanding Knowledge > 970111 Expanding Knowledge in the Medical and Health Sciences
Identification Number or DOI: 10.1016/j.jff.2018.01.024

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