Role of Ultra-processed Foods in Modulating the Effect of Mediterranean Diet
- Conditions
- Overweight
- Interventions
- Other: MD high in UPFOther: MD low in UPF
- Registration Number
- NCT06314932
- Lead Sponsor
- University of Milan
- Brief Summary
Mediterranean diet is worldwide promoted as one of the healthiest and most sustainable dietary patterns. One of the main pillars of Mediterranean diet is the abundant consumption of plant-based ingredients typically consumed as raw or minimally processed. However, even in the Mediterranean countries, these fresh foods are increasingly replaced by ultra-processed foods (UPF). Epidemiological evidence suggests that consumption of UPF may be detrimental to human health, but there is only one clinical trial on this topic which is largely debated in the scientific community due to limitations related to the short duration of the trial and the composition of dietary interventions.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- age >18 years
- BMI between 25.0 and 29.9 kg/m2 and the simultaneous presence of at least one of the following criteria, defined by the Guidelines for cardiovascular disease prevention of the European Society of Cardiology:
- total cholesterol levels >190 mg/dL
- LDL-cholesterol levels >115 mg/dL
- triglyceride levels >150 mg/dL
- glucose levels in the range 111-125 mg/dL
- presence of current serious illness or unstable condition that requires physician supervision of diet (e.g., recent myocardial infarction, chronic liver disease, inflammatory bowel diseases, renal or digestive disorders)
- pregnancy or intention to become pregnant in the next 12 months
- lactation
- current or recent (past 3 months) use of supplements or antibiotic therapy
- current or recent (past 6 months) adoption of specific restrictive diets (e.g., low-calorie or vegetarian diets)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description High UPF MD high in UPF Group starting with the Mediterranean diet (MD) high in ultra-processed foods (UPF) High UPF MD low in UPF Group starting with the Mediterranean diet (MD) high in ultra-processed foods (UPF) Low UPF MD low in UPF Group starting with the Mediterranean diet (MD) low in ultra-processed foods (UPF) Low UPF MD high in UPF Group starting with the Mediterranean diet (MD) low in ultra-processed foods (UPF)
- Primary Outcome Measures
Name Time Method Low-density lipoprotein (LDL) cholesterol levels 7 months Measurement of LDL-cholesterol levels change from the beginning to the end of each of the two intervention phases in mg/dL
- Secondary Outcome Measures
Name Time Method High-density lipoprotein (HDL) cholesterol levels 7 months Measurement of HDL cholesterol levels change from the beginning to the end of each of the two intervention phases in mg/dL
Concentration of interferon gamma (IFN-γ) in plasma 7 months Measurement of IFN-γ change from the beginning to the end of each of the two intervention phases in pg/mL
Concentration of tumor necrosis factor -alpha (TNF-α) in plasma 7 months Measurement of TNF-α change from the beginning to the end of each of the two intervention phases in pg/mL
Triglycerides levels 7 months Measurement of triglyceride levels change from the beginning to the end of each of the two intervention phases in mg/dL
Folates levels 7 months Measurement of folate levels change from the beginning to the end of each of the two intervention phases in ng/mL
Fat mass 7 months Measurement of fat mass change from the beginning to the end of each of the two intervention phases. Percentage of fat mass will be assessed using the Akern bioelectrical impedance analyser (model SE 101).
Concentration of ghrelin in plasma 7 months Measurement of ghrelin change from the beginning to the end of each of the two intervention phases in pg/mL
Body weight 7 months Measurement of body weight change from the beginning to the end of each of the two intervention phases in kg
Urea levels 7 months Measurement of urea levels change from the beginning to the end of each of the two intervention phases in mg/dL
Concentration of adiponectin in plasma 7 months Measurement of adiponectin change from the beginning to the end of each of the two intervention phases in microg/mL
Concentration of interleukin (IL)-6 in plasma 7 months Measurement of IL-6 change from the beginning to the end of each of the two intervention phases in pg/mL
DNA damage expressed as number of DNA strand breaks induced by hydrogen peroxide (H2O2) 7 months Measurement of H2O2-induced DNA strand breaks change from the beginning to the end of each of the two intervention phases in percentage (%)
Body mass index (BMI) 7 months Measurement of BMI change from the beginning to the end of each of the two intervention phases. Weight and height will be combined to report BMI in kg/m\^2
Fasting blood glucose levels 7 months Measurement of fasting blood glucose levels change from the beginning to the end of each of the two intervention phases in mg/dL
Aspartate aminotransferase (AST) levels 7 months Measurement of AST levels change from the beginning to the end of each of the two intervention phases in U/I
Creatinine levels 7 months Measurement of creatinine levels change from the beginning to the end of each of the two intervention phases in mg/dL
Concentration of visfatin in plasma 7 months Measurement of visfatin change from the beginning to the end of each of the two intervention phases in ng/mL
Total cholesterol levels 7 months Measurement of total cholesterol levels change from the beginning to the end of each of the two intervention phases in mg/dL
Insulin levels 7 months Measurement of insulin levels change from the beginning to the end of each of the two intervention phases in U/I
Alanine aminotransferase (ALT) levels 7 months Measurement of ALT levels change from the beginning to the end of each of the two intervention phases in U/I
Gamma-glutamyl transferase (GGT) levels 7 months Measurement of GGT levels change from the beginning to the end of each of the two intervention phases in U/I
Vitamin B12 levels 7 months Measurement of vitamin B12 levels change from the beginning to the end of each of the two intervention phases in pg/mL
Concentration of leptin in plasma 7 months Measurement of leptin change from the beginning to the end of each of the two intervention phases in ng/mL
Concentration of resistin in plasma 7 months Measurement of resistin change from the beginning to the end of each of the two intervention phases in ng/mL
Concentration of interleukin (IL)-4 in plasma 7 months Measurement of IL-4 change from the beginning to the end of each of the two intervention phases in pg/mL
Concentration of Protein C-reactive (PCR) in plasma 7 months Measurement of protein C-reactive (PCR) change from the beginning to the end of each of the two intervention phases in mg/L
Concentration of F2-isoprostanes in urine 7 months Measurement of F2-isoprostanes change from the beginning to the end of each of the two intervention phases in pg/mosm
Gut microbiota composition and function changes 7 months Measurement of gut microbiota composition change from the beginning to the end of each of the two intervention phases. Each subject will be asked for a stool sample at the beginning and at the end of each intervention phases in order to analyse the composition of the gut microbiota and short-chain fatty acids production.
Concentration of interleukin (IL)-10 in plasma 7 months Measurement of IL-10 change from the beginning to the end of each of the two intervention phases in pg/mL
Trial Locations
- Locations (2)
University of Florence
🇮🇹Florence, Italy
University of Milan
🇮🇹Milan, Italy