Guidelines for nutritional intervention studies on BEF effectiveness with a special focus on pilot studies

The guidelines presented here have been developed through consultation with PATHWAY-27 project partners to provide practical guidance for designing, implementing and reporting pilot intervention studies using bioactive enriched foods (BEF). These guidelines update and complement previously published guidance documents, but are unique in providing practical information and troubleshooting based on the PATHWAY-27 pilot studies.

The aim of PATHWAY-27 is to evaluate the effectiveness of BEF containing docosahexaenoic acid (DHA), anthocyanins (AC) and beta-glucan (BG) alone or in combination, on improving risk factors of the metabolic syndrome (MetS). These compounds were chosen for their known effects as single compounds, and considered as ingredients of BEF in three different widely consumed food matrices (dairy, bakery and egg products). This approach of using BEF, compared to single pure compounds, will allow a better understanding of possible bioactive synergisms and bioactive-matrix interactions. This knowledge will increase the potential for exploitation of bioactive and BEF commercialization by the food industry.

A pilot trial is a small-scale study that is used to test the physiological effects and participant acceptance of prototype formulations in order to select food products to be tested in a larger scale trial. The pilot is also a great opportunity to test the data collection methods, procedures and logistics that can provide early identification of problems in order to find suitable solutions that can be implemented to improve the quality and efficiency of the main trial.

With examples gathered from the PATHWAY-27 project, this guidance document describes the requirements for the formulation and production of BEF, the design and conductance of a pilot trial, and how the data and information gathered can be used to inform further larger trials and the best practice for public reporting.