2.4. Study Design and Dietary Monitoring
dizziness, vomiting, flushing, bloating, diarrhea
ADVERSE EFFECTS, BLOOD
The study carried out was a prospective, controlled, randomized two-arm longitudinal crossover trial [Clinical Trial: NCT06161883], performed in a single center, as indicated in After a run-in period of two weeks, the study was carried out for 14 weeks, including two sequential intervention periods (6 weeks each). In the first intervention period, participants were randomly separated into two different arms (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. Dietary patterns, assessed using food frequency questionnaires, were documented before each visit, and minimal alterations in dietary habits were reported. Adherence was monitored through regular telephone communication with participants, coupled with interviews conducted at the conclusion of each intervention period. Volunteers also recorded whether they had consumed tomato or tomato-based products on a diary card each day. Additionally, a clinician evaluated potential side effects or symptoms, such as flushing, bloating, dizziness, vomiting, and diarrhea, which could be linked to soffritto intake, at the conclusion of each intervention period. However, no adverse effects were observed in the volunteers.Blood samples, obtained following a twelve-hour fasting period, were collected on days 1 and 42 to establish baseline and first treatment period endpoints. Similarly, blood samples were obtained on days 56 and 98, representing baseline and second treatment period endpoints (