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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06314932
Acronym
PROMENADE
Enrollment
50
Registered
2024-03-18
Start date
2024-04-30
Completion date
2025-06-30
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight

Keywords

Mediterranean diet, Food processing, Human health, Sustainability

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.

Interventions

OTHERMD 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).

OTHERMD 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)

Sponsors

University of Florence
CollaboratorOTHER
University of Teramo
CollaboratorOTHER
University of Milan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Low-density lipoprotein (LDL) cholesterol levels7 monthsMeasurement of LDL-cholesterol levels change from the beginning to the end of each of the two intervention phases in mg/dL

Secondary

MeasureTime frameDescription
Total cholesterol levels7 monthsMeasurement of total cholesterol levels change from the beginning to the end of each of the two intervention phases in mg/dL
High-density lipoprotein (HDL) cholesterol levels7 monthsMeasurement of HDL cholesterol levels change from the beginning to the end of each of the two intervention phases in mg/dL
Triglycerides levels7 monthsMeasurement of triglyceride levels change from the beginning to the end of each of the two intervention phases in mg/dL
Fasting blood glucose levels7 monthsMeasurement of fasting blood glucose levels change from the beginning to the end of each of the two intervention phases in mg/dL
Insulin levels7 monthsMeasurement of insulin levels change from the beginning to the end of each of the two intervention phases in U/I
Aspartate aminotransferase (AST) levels7 monthsMeasurement of AST levels change from the beginning to the end of each of the two intervention phases in U/I
Alanine aminotransferase (ALT) levels7 monthsMeasurement of ALT levels change from the beginning to the end of each of the two intervention phases in U/I
Gamma-glutamyl transferase (GGT) levels7 monthsMeasurement of GGT levels change from the beginning to the end of each of the two intervention phases in U/I
Vitamin B12 levels7 monthsMeasurement of vitamin B12 levels change from the beginning to the end of each of the two intervention phases in pg/mL
Urea levels7 monthsMeasurement of urea levels change from the beginning to the end of each of the two intervention phases in mg/dL
Creatinine levels7 monthsMeasurement of creatinine levels change from the beginning to the end of each of the two intervention phases in mg/dL
Body weight7 monthsMeasurement of body weight change from the beginning to the end of each of the two intervention phases in kg
Body mass index (BMI)7 monthsMeasurement 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
Fat mass7 monthsMeasurement 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).
Folates levels7 monthsMeasurement of folate levels change from the beginning to the end of each of the two intervention phases in ng/mL
Concentration of leptin in plasma7 monthsMeasurement of leptin change from the beginning to the end of each of the two intervention phases in ng/mL
Concentration of adiponectin in plasma7 monthsMeasurement of adiponectin change from the beginning to the end of each of the two intervention phases in microg/mL
Concentration of resistin in plasma7 monthsMeasurement of resistin change from the beginning to the end of each of the two intervention phases in ng/mL
Concentration of visfatin in plasma7 monthsMeasurement of visfatin change from the beginning to the end of each of the two intervention phases in ng/mL
Concentration of interleukin (IL)-4 in plasma7 monthsMeasurement of IL-4 change from the beginning to the end of each of the two intervention phases in pg/mL
Concentration of interleukin (IL)-6 in plasma7 monthsMeasurement of IL-6 change from the beginning to the end of each of the two intervention phases in pg/mL
Concentration of interleukin (IL)-10 in plasma7 monthsMeasurement of IL-10 change from the beginning to the end of each of the two intervention phases in pg/mL
Concentration of Protein C-reactive (PCR) in plasma7 monthsMeasurement of protein C-reactive (PCR) change from the beginning to the end of each of the two intervention phases in mg/L
Concentration of interferon gamma (IFN-γ) in plasma7 monthsMeasurement 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 plasma7 monthsMeasurement of TNF-α 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 monthsMeasurement of H2O2-induced DNA strand breaks change from the beginning to the end of each of the two intervention phases in percentage (%)
Concentration of F2-isoprostanes in urine7 monthsMeasurement 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 changes7 monthsMeasurement 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 ghrelin in plasma7 monthsMeasurement of ghrelin change from the beginning to the end of each of the two intervention phases in pg/mL

Countries

Italy

Contacts

Primary ContactDaniela Martini
daniela.martini@unimi.it+39 02503 16727

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026