The present study aims at exploring whether the inclusion of UPF within a Mediterranean-based dietary pattern can impact on cardiometabolic markers, gut microbiota and other health markers in a dietary intervention performed in Italian subjects. For this purpose, 50 clinically healthy subjects will be recruited for a 7-month randomized, open, cross-over dietary trial. Eligible participants will be randomly assigned to consume a 3-month Mediterranean diet high in UPF (intervention group) or a low-UPF Mediterranean diet (control group), spaced by a 1-month wash-out period. The two diets will have the same composition in terms of food groups. However, in the high-UPF Mediterranean diet group, 5 servings/day of UPF, as defined by the NOVA system, will be consumed (e.g., flavored yogurt, breakfast cereals with added sugar, processed meat). In the control group, these foods will be replaced by products from the same food group, but not UPF (e.g., plain yogurt, breakfast cereals with no added sugar, unprocessed meat). The inflammatory potential of pairs of food products, both UPF and non UPF, will be evaluated using an in vitro cell model testing the modulation of inflammatory markers. Before and after each intervention blood, urine and fecal samples will be collected. The primary endpoint is change in low-density lipoprotein (LDL) cholesterol levels from baseline. Among the other markers, blood pressure and anthropometric parameters will be measured; biochemical parameters, adipokines, inflammatory and oxidative stress markers, fecal microbiota composition and short chain fatty acids (SCFAs) will be analyzed. Adherence to the study, dietary intake and food waste production will be evaluated through specific food diaries, useful also for estimating the metabolic food waste. conditions: Overweight studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: CROSSOVER primaryPurpose: PREVENTION masking: SINGLE whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: MD high in UPF name: MD low in UPF measure: Low-density lipoprotein (LDL) cholesterol levels measure: Total cholesterol levels measure: High-density lipoprotein (HDL) cholesterol levels measure: Triglycerides levels measure: Fasting blood glucose levels measure: Insulin levels measure: Aspartate aminotransferase (AST) levels measure: Alanine aminotransferase (ALT) levels measure: Gamma-glutamyl transferase (GGT) levels measure: Folates levels measure: Vitamin B12 levels measure: Urea levels measure: Creatinine levels measure: Body weight measure: Body mass index (BMI) measure: Fat mass measure: Concentration of ghrelin in plasma measure: Concentration of leptin in plasma measure: Concentration of adiponectin in plasma measure: Concentration of resistin in plasma measure: Concentration of visfatin in plasma measure: Concentration of interleukin (IL)-4 in plasma measure: Concentration of interleukin (IL)-6 in plasma measure: Concentration of interleukin (IL)-10 in plasma measure: Concentration of Protein C-reactive (PCR) in plasma measure: Concentration of interferon gamma (IFN-γ) in plasma measure: Concentration of tumor necrosis factor -alpha (TNF-α) in plasma measure: DNA damage expressed as number of DNA strand breaks induced by hydrogen peroxide (H2O2) measure: Concentration of F2-isoprostanes in urine measure: Gut microbiota composition and function changes sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Florence city: Florence zip: 54141 country: Italy name: Monica Dinu role: CONTACT phone: +39 349 3465184 email: monica.dinu@unifi.it lat: 43.77925 lon: 11.24626 facility: University of Milan city: Milan zip: 20133 country: Italy name: Daniela Martini role: CONTACT phone: +39 02503 16727 email: daniela.martini@unimi.it lat: 45.46427 lon: 9.18951 hasResults: False