3. Results
ADVERSE EFFECTS
The prospective, two-arm longitudinal crossover design, including enrollment, the randomization scheme, and final sample distributions by treatment group, are presented in the Consolidated Standards of Reporting Trials (CONSORT) diagram (The study was carried out in a group of 40 individuals (13 women and 27 men) with an average age of 40.8 ± 1.3 years. The entire study population completed both treatment phases, and no adverse effects were observed during the consumption of the tomato products. Adherence to the study dietary pattern was >97% during the 6 weeks of the intervention period. During the duration of the study, the volunteers were asked to maintain their usual diet, excluding raw or cooked tomatoes as well as tomato-based products (sauces, ketchup, juices, etc.) other than those administered during the study in the corresponding periods. Eighty-five percent of the individuals declared to have followed the indicated instructions, and 15% reported to have taken sporadically tomato or ketchup (4–8% of the days) within the usual range of a daily diet, irrespectively of the intervention stage (wash-out period, control, or soffritto intervention period). Therefore, all the individuals were included in the statistical study. 