Challenges in the design, interpretation, and reporting of randomized controlled clinical studies on the health effects of whole foods

Appl Physiol Nutr Metab. 2021 Sep;46(9):1152-1158. doi: 10.1139/apnm-2021-0007. Epub 2021 May 28.


Given the challenges with nutrition research, the Canadian Nutrition Society and Intertek Health Sciences Inc held an expert consultation in late 2019 to discuss the development and implementation of best practices for clinical trials on whole foods. Key challenges in the design, interpretation, and reporting of clinical efficacy studies on whole foods and opportunities for the future development of best practices are reported. Novelty: Outlines existing tools, resources, and checklists for clinical nutrition trials and provides clear and tangible steps to develop best practices for studies on whole foods.

Keywords: aliments entiers; allégations de santé; best practices; conception des études; essais contrôlés randomisés; health claims; meilleures pratiques; observational studies; randomized controlled trials; study design; whole foods; études observationnelles.

MeSH terms

  • Canada
  • Checklist
  • Food
  • Humans
  • Nutritional Sciences*
  • Practice Guidelines as Topic
  • Randomized Controlled Trials as Topic / methods*
  • Randomized Controlled Trials as Topic / standards*
  • Research Design
  • Research Report