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

NCT06314932 | Not Yet Recruiting

• 1 other identifier: spe123.23
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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

Keywords

Mediterranean diet; Food processing; Human health; Sustainability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (29)

• Total cholesterol levels

  7 months

• High-density lipoprotein (HDL) cholesterol levels

  7 months

• Triglycerides levels

  7 months

• Fasting blood glucose levels

  7 months

• Insulin levels

  7 months

Study Arms (2)

High UPF

EXPERIMENTAL

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

Other: MD high in UPF; Other: MD low in UPF

Low UPF

ACTIVE COMPARATOR

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

Other: MD high in UPF; Other: MD low in UPF

Interventions

MD high in UPF 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).

High UPF; Low UPF

MD low in UPF 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)

High UPF; Low UPF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Milan: lead
• University of Florence: collaborator
• University of Teramo: collaborator

Study Sites (2)

University of Florence

Florence, 54141, Italy

Location

University of Milan

Milan, 20133, Italy

Location

Related Publications (1)

• 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.

  PMID: 39350201 DERIVED

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Daniela Martini

CONTACT

+39 02503 16727; daniela.martini@unimi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 18, 2024
• Study Start: April 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: June 1, 2025
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

IT (2)