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

NCT ID: NCT06314932

Last Updated: 2024-03-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-30
• Study Completion Date: 2025-06-30

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.

Conditions

Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

High UPF

Group starting with the Mediterranean diet (MD) high in ultra-processed foods (UPF)

Group Type: EXPERIMENTAL

MD high in UPF

Intervention Type: OTHER

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

Intervention Type: OTHER

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)

Low UPF

Group starting with the Mediterranean diet (MD) low in ultra-processed foods (UPF)

Group Type: ACTIVE_COMPARATOR

MD high in UPF

Intervention Type: OTHER

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

Intervention Type: OTHER

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)

Interventions

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).

Intervention Type: OTHER

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)

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florence

OTHER

Sponsor Role: collaborator

University of Teramo

OTHER

Sponsor Role: collaborator

University of Milan

OTHER

Sponsor Role: lead

Responsible Party

Daniela Martini

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Florence

Florence, , Italy

University of Milan

Milan, , Italy

Countries

Italy

Central Contacts

Daniela Martini

Role: CONTACT

daniela.martini@unimi.it

+39 02503 16727

Facility Contacts

Monica Dinu

Role: primary

monica.dinu@unifi.it

+39 349 3465184

Daniela Martini

Role: primary

daniela.martini@unimi.it

+39 02503 16727

References

Dinu M, Angelino D, Del Bo' C, Serafini M, Sofi F, Martini D. Role of ultra-processed foods in modulating the effect of Mediterranean diet on human and planet health-study protocol of the PROMENADE randomized controlled trial. Trials. 2024 Sep 30;25(1):641. doi: 10.1186/s13063-024-08470-6.

Reference Type: DERIVED

PMID: 39350201 (View on PubMed)

Other Identifiers

spe123.23

Identifier Type: -

Identifier Source: org_study_id