Clinical trial NCT06314932: Role of Ultra-processed Foods in Modulating the Effect of Mediterranean Diet
Official title: Role of ultraPROcessed Foods in Modulating the Effect of mEditerraNeAn Diet on Human and Planet hEalth - the PROMENADE Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Overweight
Keywords: Mediterranean diet
Food processing
Human health
Sustainability
Lead sponsor: University of Milan
Sponsor class: OTHER
Collaborators: name: University of Florence
name: University of Teramo
First posted: 2024-03-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Low-density lipoprotein (LDL) cholesterol levels
timeFrame: 7 months
Secondary outcomes:
measure: Total cholesterol levels
timeFrame: 7 months
measure: High-density lipoprotein (HDL) cholesterol levels
timeFrame: 7 months
measure: Triglycerides levels
timeFrame: 7 months
measure: Fasting blood glucose levels
timeFrame: 7 months
measure: Insulin levels
timeFrame: 7 months
measure: Aspartate aminotransferase (AST) levels
timeFrame: 7 months
measure: Alanine aminotransferase (ALT) levels
timeFrame: 7 months
measure: Gamma-glutamyl transferase (GGT) levels
timeFrame: 7 months
measure: Folates levels
timeFrame: 7 months
measure: Vitamin B12 levels
timeFrame: 7 months
measure: Urea levels
timeFrame: 7 months
measure: Creatinine levels
timeFrame: 7 months
measure: Body weight
timeFrame: 7 months
measure: Body mass index (BMI)
timeFrame: 7 months
measure: Fat mass
timeFrame: 7 months
measure: Concentration of ghrelin in plasma
timeFrame: 7 months
measure: Concentration of leptin in plasma
timeFrame: 7 months
measure: Concentration of adiponectin in plasma
timeFrame: 7 months
measure: Concentration of resistin in plasma
timeFrame: 7 months
measure: Concentration of visfatin in plasma
timeFrame: 7 months
measure: Concentration of interleukin (IL)-4 in plasma
timeFrame: 7 months
measure: Concentration of interleukin (IL)-6 in plasma
timeFrame: 7 months
measure: Concentration of interleukin (IL)-10 in plasma
timeFrame: 7 months
measure: Concentration of Protein C-reactive (PCR) in plasma
timeFrame: 7 months
measure: Concentration of interferon gamma (IFN-γ) in plasma
timeFrame: 7 months
measure: Concentration of tumor necrosis factor -alpha (TNF-α) in plasma
timeFrame: 7 months
measure: DNA damage expressed as number of DNA strand breaks induced by hydrogen peroxide (H2O2)
timeFrame: 7 months
measure: Concentration of F2-isoprostanes in urine
timeFrame: 7 months
measure: Gut microbiota composition and function changes
timeFrame: 7 months
Other outcomes:
Locations:
city: Florence
country: Italy
facility: University of Florence
city: Milan
country: Italy
facility: University of Milan
Study officials:
References: