Role of Ultra-processed Foods in Modulating the Effect of Mediterranean Diet

Overweight Clinical Trial

— PROMENADE  

Official title:

Role of ultraPROcessed Foods in Modulating the Effect of mEditerraNeAn Diet on Human and Planet hEalth - the PROMENADE Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06314932
• Other study ID #: spe123.23
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: University of Milan
• Contact: Daniela Martini
• Phone: +39 02503 16727
• Email: daniela.martini[@]unimi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: June 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Overweight

Intervention

Other:
• MD high in UPF
A 3-month dietary intervention with a Mediterranean diet with 5 servings/day of UPF, as defined by the NOVA system (e.g., flavored yogurt, breakfast cereals with added sugar, processed meat).
• MD low in UPF
A 3-month dietary intervention with a Mediterranean diet with 5 servings/day of products from the same food group, but non-UPF (e.g., plain yogurt, breakfast cereals with no added sugar, unprocessed meat)

Locations

Country	Name	City	State
Italy	University of Florence	Florence
Italy	University of Milan	Milan

Sponsors (3)

Lead Sponsor	Collaborator
University of Milan	University of Florence, University of Teramo

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Low-density lipoprotein (LDL) cholesterol levels	Measurement of LDL-cholesterol levels change from the beginning to the end of each of the two intervention phases in mg/dL	7 months
Secondary	Total cholesterol levels	Measurement of total cholesterol levels change from the beginning to the end of each of the two intervention phases in mg/dL	7 months
Secondary	High-density lipoprotein (HDL) cholesterol levels	Measurement of HDL cholesterol levels change from the beginning to the end of each of the two intervention phases in mg/dL	7 months
Secondary	Triglycerides levels	Measurement of triglyceride levels change from the beginning to the end of each of the two intervention phases in mg/dL	7 months
Secondary	Fasting blood glucose levels	Measurement of fasting blood glucose levels change from the beginning to the end of each of the two intervention phases in mg/dL	7 months
Secondary	Insulin levels	Measurement of insulin levels change from the beginning to the end of each of the two intervention phases in U/I	7 months
Secondary	Aspartate aminotransferase (AST) levels	Measurement of AST levels change from the beginning to the end of each of the two intervention phases in U/I	7 months
Secondary	Alanine aminotransferase (ALT) levels	Measurement of ALT levels change from the beginning to the end of each of the two intervention phases in U/I	7 months
Secondary	Gamma-glutamyl transferase (GGT) levels	Measurement of GGT levels change from the beginning to the end of each of the two intervention phases in U/I	7 months
Secondary	Folates levels	Measurement of folate levels change from the beginning to the end of each of the two intervention phases in ng/mL	7 months
Secondary	Vitamin B12 levels	Measurement of vitamin B12 levels change from the beginning to the end of each of the two intervention phases in pg/mL	7 months
Secondary	Urea levels	Measurement of urea levels change from the beginning to the end of each of the two intervention phases in mg/dL	7 months
Secondary	Creatinine levels	Measurement of creatinine levels change from the beginning to the end of each of the two intervention phases in mg/dL	7 months
Secondary	Body weight	Measurement of body weight change from the beginning to the end of each of the two intervention phases in kg	7 months
Secondary	Body mass index (BMI)	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	7 months
Secondary	Fat mass	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).	7 months
Secondary	Concentration of ghrelin in plasma	Measurement of ghrelin change from the beginning to the end of each of the two intervention phases in pg/mL	7 months
Secondary	Concentration of leptin in plasma	Measurement of leptin change from the beginning to the end of each of the two intervention phases in ng/mL	7 months
Secondary	Concentration of adiponectin in plasma	Measurement of adiponectin change from the beginning to the end of each of the two intervention phases in microg/mL	7 months
Secondary	Concentration of resistin in plasma	Measurement of resistin change from the beginning to the end of each of the two intervention phases in ng/mL	7 months
Secondary	Concentration of visfatin in plasma	Measurement of visfatin change from the beginning to the end of each of the two intervention phases in ng/mL	7 months
Secondary	Concentration of interleukin (IL)-4 in plasma	Measurement of IL-4 change from the beginning to the end of each of the two intervention phases in pg/mL	7 months
Secondary	Concentration of interleukin (IL)-6 in plasma	Measurement of IL-6 change from the beginning to the end of each of the two intervention phases in pg/mL	7 months
Secondary	Concentration of interleukin (IL)-10 in plasma	Measurement of IL-10 change from the beginning to the end of each of the two intervention phases in pg/mL	7 months
Secondary	Concentration of Protein C-reactive (PCR) in plasma	Measurement of protein C-reactive (PCR) change from the beginning to the end of each of the two intervention phases in mg/L	7 months
Secondary	Concentration of interferon gamma (IFN-?) in plasma	Measurement of IFN-? change from the beginning to the end of each of the two intervention phases in pg/mL	7 months
Secondary	Concentration of tumor necrosis factor -alpha (TNF-a) in plasma	Measurement of TNF-a change from the beginning to the end of each of the two intervention phases in pg/mL	7 months
Secondary	DNA damage expressed as number of DNA strand breaks induced by hydrogen peroxide (H2O2)	Measurement of H2O2-induced DNA strand breaks change from the beginning to the end of each of the two intervention phases in percentage (%)	7 months
Secondary	Concentration of F2-isoprostanes in urine	Measurement of F2-isoprostanes change from the beginning to the end of each of the two intervention phases in pg/mosm	7 months
Secondary	Gut microbiota composition and function changes	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.	7 months