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Protocols (Poster Session)

(P30-030-24) Role of Ultra-Processed Foods in Modulating the Effect of Mediterranean Diet on Human and Planet Health: The Study Protocol of the PROMENADE Project

Monday, July 1, 2024
12:45 PM – 1:45 PM CT
Location: Poster Board 28

    Presenting Author(s)

  • Daniela Martini, PhD (she/her/hers)

    Associate Professor
    University of Milan
    milan, Lombardia, Italy

    • Co-Author(s)

  • Donato Angelino, PhD (he/him/his)

    Associate Professor
    University of Teramo, Functional Food and Metabolic Stress Prevention Laboratory, Department of Bioscience and Technology for Food, Agriculture and Environment
    Teramo, Abruzzi, Italy

  • CD

    Cristian Del Bo', PhD (he/him/his)

    Associate Professor
    Division of Human Nutrition, Department of Food, Environmental and Nutritional Sciences, University of Milan
    Milan, Lombardia, Italy

  • MS

    Mauro Serafini

    University of Teramo, Functional Food and Metabolic Stress Prevention Laboratory, Department of Bioscience and Technology for Food, Agriculture and Environment
    Teramo, Italy

  • FS

    Francesco Sofi

    University of Florence, Italy

  • MD

    Monica Dinu

    University of Florence, Italy

Disclosure(s):
Donato Angelino, PhD: No relevant financial relationship(s) with ineligible companies to disclose.
Cristian Del Bo', PhD: No relevant financial relationship(s) with ineligible companies to disclose.


Objectives: The Mediterranean diet (MD), globally recognized for its health and sustainability benefits, traditionally emphasizes the consumption of plant-based foods in raw or minimally processed forms. However, shifting lifestyles, even in Mediterranean regions, have led to an increasing consumption of ultra-processed foods (UPF). Epidemiological evidence suggests that UPF consumption may be detrimental to human health, but there is only one clinical trial on this topic which is largely debated in the scientific community. This study aims to investigate the impact of the inclusion of UPF within a Mediterranean-based dietary pattern on cardiometabolic markers, gut microbiota, and other markers of human and planet health.

Methods: Fifty clinically healthy Italian subjects with a low-to-moderate cardiovascular risk profile will be recruited for a 7-month randomized, open, cross-over dietary trial. Eligible participants will be randomly assigned to a 3-month high-UPF MD (intervention group) or a low-UPF MD (control group), with a 1-month wash-out period. Both diets will be normocaloric and have identical food group compositions, with the intervention group consuming 5 servings/day of selected UPF items, and the control group consuming raw/minimally processed items from the same food group. Blood, urine, and fecal samples, alongside food/lifestyle diaries, will be collected from each participant before and after the dietary interventions. The primary endpoint will be the change in plasma LDL-cholesterol levels from baseline. Additional markers include blood pressure, anthropometric parameters, chemical chemistry parameters, glucose and lipid-related metabolic markers, incretins, inflammatory and oxidative stress markers, fecal microbiota composition, and short-chain fatty acids. Finally, food waste production will be evaluated through specific validated food diaries.

Results: N/A

Conclusions: Results from the PROMENADE study will improve knowledge about the impact of UPF consumption on human and planet health and will contribute to the scientific debate on this topic.

Funding Sources: The project was funded under the project PRIN 2022 funded by the European Union – NextGenerationEU.