Grant: Planning and Dissemination Grant - Institute Community Support

When positioning foods to consumers, the use of front-of-package claims provides important messaging that can describe the beneficial health effects associated with the consumption of specific foods or derived food ingredients. Health claims on foods are specific statements, regulated by Health Canada, that are designed to convey evidence-based relationships between food/food component consumption and public health. These claims are often the most powerful tools to provide health-related messaging to consumers on the role of specific foods, including statements related to disease-reduction. Supporting data for health claims on foods must be based on high-quality, non-biased human clinical studies, with randomized controlled studies providing the highest level of evidence. A challenge exists when designing and executing RCTs investigating the linkage between whole food consumption and a specific biological impact linked to nutrition-related chronic diseases (ie: change in blood cholesterol; change in blood pressure; change in blood glucose concentrations). In drug studies, it is easy to provide a placebo and to blind participants to the treatment (ie: same colour capsule containing an inert agent), and these attributes are key for standard RCT studies. For whole foods (ie: eggs, fish, whole grains, blueberries, etc...), it is often not possible to provide an appropriate placebo, nor is it possible to adequately "blind" participants to the foods they are consuming. As a result, whole food RCTs tend to be discounted by regulatory bodies due to inadequate design. This is a waste of time, money and resources. There is a need to develop "Best Practices for the Design and Implementation of RCTs involving Whole Foods to Substantiate Health Claims". This effort would guide commodity groups and the broader food industry in the development and implementation of studies designed to improve the marketability and consumption of Canadian agri-food products.