Best Practices for Food-Based Clinical Trials

This document focuses on best practices for clinical trials using foods. It describes how to plan, conduct and report on data from human nutrition research required to substantiate health claims for food in Canada. The practical manual fills a need for food and nutrition researchers to have guidance that addresses the criteria used by Health Canada to evaluate a food health claim submission.

This manual was commissioned by the Food Regulatory Issues Division of Agriculture and Agri-Food Canada and prepared by food and nutrition research experts with extensive experience in clinical trials. The methods used to create a broad, yet comprehensive guidance document include a systematic review of the literature, extensive interviews with food and nutrition researchers, and experience-based clinical practice knowledge. Although the document covers a wide range of topics, it is not intended to be a definitive manual on food-based clinical trials. Readers are encouraged to use this manual as a guide and to refer to the cited references for more information.

The report is divided into five sections. The Introduction outlines the scope of the project. Section 2 covers food health claims and their substantiation based on Health Canada requirements. Section 3 focuses on pre-clinical trial activities, and includes details on generating a research question and hypothesis, choosing a study design and study population, preparing test products and selecting control foods. Section 4 thoroughly covers clinical trial implementation, including recruitment of participants, managing research diets, and record keeping. Section 5 details post-clinical trial activities such as sample analysis, data analysis and publishing. Each of these sections begins with an overall Summary and includes synopses of Best Practices Keypoints. The resource also includes a brief conclusion, appendices, a list of references and a short glossary.

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