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

March 13, 2024 updated by: Daniela Martini, University of Milan

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Florence, Italy, 54141
        • University of Florence
        • Contact:
      • Milan, Italy, 20133

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High UPF
Group starting with the Mediterranean diet (MD) high in ultra-processed foods (UPF)
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).
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)
Active Comparator: Low UPF
Group starting with the Mediterranean diet (MD) low in ultra-processed foods (UPF)
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).
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Low-density lipoprotein (LDL) cholesterol levels
Time Frame: 7 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total cholesterol levels
Time Frame: 7 months
Measurement of total cholesterol levels change from the beginning to the end of each of the two intervention phases in mg/dL
7 months
High-density lipoprotein (HDL) cholesterol levels
Time Frame: 7 months
Measurement of HDL cholesterol levels change from the beginning to the end of each of the two intervention phases in mg/dL
7 months
Triglycerides levels
Time Frame: 7 months
Measurement of triglyceride levels change from the beginning to the end of each of the two intervention phases in mg/dL
7 months
Fasting blood glucose levels
Time Frame: 7 months
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
Insulin levels
Time Frame: 7 months
Measurement of insulin levels change from the beginning to the end of each of the two intervention phases in U/I
7 months
Aspartate aminotransferase (AST) levels
Time Frame: 7 months
Measurement of AST levels change from the beginning to the end of each of the two intervention phases in U/I
7 months
Alanine aminotransferase (ALT) levels
Time Frame: 7 months
Measurement of ALT levels change from the beginning to the end of each of the two intervention phases in U/I
7 months
Gamma-glutamyl transferase (GGT) levels
Time Frame: 7 months
Measurement of GGT levels change from the beginning to the end of each of the two intervention phases in U/I
7 months
Folates levels
Time Frame: 7 months
Measurement of folate levels change from the beginning to the end of each of the two intervention phases in ng/mL
7 months
Vitamin B12 levels
Time Frame: 7 months
Measurement of vitamin B12 levels change from the beginning to the end of each of the two intervention phases in pg/mL
7 months
Urea levels
Time Frame: 7 months
Measurement of urea levels change from the beginning to the end of each of the two intervention phases in mg/dL
7 months
Creatinine levels
Time Frame: 7 months
Measurement of creatinine levels change from the beginning to the end of each of the two intervention phases in mg/dL
7 months
Body weight
Time Frame: 7 months
Measurement of body weight change from the beginning to the end of each of the two intervention phases in kg
7 months
Body mass index (BMI)
Time Frame: 7 months
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
Fat mass
Time Frame: 7 months
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
Concentration of ghrelin in plasma
Time Frame: 7 months
Measurement of ghrelin change from the beginning to the end of each of the two intervention phases in pg/mL
7 months
Concentration of leptin in plasma
Time Frame: 7 months
Measurement of leptin change from the beginning to the end of each of the two intervention phases in ng/mL
7 months
Concentration of adiponectin in plasma
Time Frame: 7 months
Measurement of adiponectin change from the beginning to the end of each of the two intervention phases in microg/mL
7 months
Concentration of resistin in plasma
Time Frame: 7 months
Measurement of resistin change from the beginning to the end of each of the two intervention phases in ng/mL
7 months
Concentration of visfatin in plasma
Time Frame: 7 months
Measurement of visfatin change from the beginning to the end of each of the two intervention phases in ng/mL
7 months
Concentration of interleukin (IL)-4 in plasma
Time Frame: 7 months
Measurement of IL-4 change from the beginning to the end of each of the two intervention phases in pg/mL
7 months
Concentration of interleukin (IL)-6 in plasma
Time Frame: 7 months
Measurement of IL-6 change from the beginning to the end of each of the two intervention phases in pg/mL
7 months
Concentration of interleukin (IL)-10 in plasma
Time Frame: 7 months
Measurement of IL-10 change from the beginning to the end of each of the two intervention phases in pg/mL
7 months
Concentration of Protein C-reactive (PCR) in plasma
Time Frame: 7 months
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
Concentration of interferon gamma (IFN-γ) in plasma
Time Frame: 7 months
Measurement of IFN-γ change from the beginning to the end of each of the two intervention phases in pg/mL
7 months
Concentration of tumor necrosis factor -alpha (TNF-α) in plasma
Time Frame: 7 months
Measurement of TNF-α change from the beginning to the end of each of the two intervention phases in pg/mL
7 months
DNA damage expressed as number of DNA strand breaks induced by hydrogen peroxide (H2O2)
Time Frame: 7 months
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
Concentration of F2-isoprostanes in urine
Time Frame: 7 months
Measurement of F2-isoprostanes change from the beginning to the end of each of the two intervention phases in pg/mosm
7 months
Gut microbiota composition and function changes
Time Frame: 7 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Milan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Florence
University of Teramo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • spe123.23

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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