Consumption of organic and conventional food: Randomized Clinical Trial

Randomized Clinical Trials are considered the gold standard for studies with dietary intervention, mainly because they can establish causal relationships between food exposure or dietary patterns and body composition measures or biomarkers. Therefore, guidelines for designing, conducting, documenting and reporting these experimental designs in the area of nutrition need to be developed and disseminated as a reference for the academic community. The aim of this study was to perform a double-blind randomized clinical trial protocol to characterize and evaluate the effects of human food exposure to pesticide residues in food. Specific aspects of planning (development of a research question, determination of objectives, selection of participants, randomization and blinding) and conduction (recruitment of participants, measures to improve adherence, data collection, follow-up and evaluation of results) are addressed in this study.The study design proved to be effective in characterizing dietary patterns with foods from conventional and organic farming. However, difficulties were observed during the Clinical Trial, such as the recruitment of a larger sample number (total N = 148), adherence to meals such as breakfast, interference in the food routine and eventual underreporting of the consumption of extra foods. The practice of evidence-based nutrition has demanded that trials be well designed and systematically performed in the field of clinical nutrition. Therefore, this Clinical Trial emphasizes the importance of improving studies with toxicological nutrition that assess sources of exposure through food.