OverweightPROMENADENCT06314932
Role of Ultra-processed Foods in Modulating the Effect of Mediterranean Diet
A study testing MD high in UPF and MD low in UPF in people with Overweight, run by University of Milan at 2 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight
- What is being tested?
- MD high in UPF and MD low in UPF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesItaly
- Study dates
- Apr 2024to Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
University of Florence
Florence, 54141
Monica Dinu, +39 349 3465184, monica.dinu@unifi.it
University of Milan
Milan, 20133
Daniela Martini, +39 02503 16727, daniela.martini@unimi.it
About this study
Official title: 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.
- Conditions
- Overweight
- Being tested
- MD high in UPF, MD low in UPF
- Keywords
- Mediterranean diet, Food processing, Human health, Sustainability
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MD high in UPFOther
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 UPFOther
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)
| Study group | Role | What they receive |
|---|---|---|
| High UPF | Experimental | Group starting with the Mediterranean diet (MD) high in ultra-processed foods (UPF) Receives: 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) Receives: Other: MD high in UPF; Other: MD low in UPF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 months
Secondary outcomes (29)
Total cholesterol levels
Measurement of total cholesterol levels change from the beginning to the end of each of the two intervention phases in mg/dL
Measured: 7 months
High-density lipoprotein (HDL) cholesterol levels
Measurement of HDL cholesterol levels change from the beginning to the end of each of the two intervention phases in mg/dL
Measured: 7 months
Triglycerides levels
Measurement of triglyceride levels change from the beginning to the end of each of the two intervention phases in mg/dL
Measured: 7 months
Fasting blood glucose levels
Measurement of fasting blood glucose levels change from the beginning to the end of each of the two intervention phases in mg/dL
Measured: 7 months
Insulin levels
Measurement of insulin levels change from the beginning to the end of each of the two intervention phases in U/I
Measured: 7 months
Aspartate aminotransferase (AST) levels
Measurement of AST levels change from the beginning to the end of each of the two intervention phases in U/I
Measured: 7 months
Alanine aminotransferase (ALT) levels
Measurement of ALT levels change from the beginning to the end of each of the two intervention phases in U/I
Measured: 7 months
Gamma-glutamyl transferase (GGT) levels
Measurement of GGT levels change from the beginning to the end of each of the two intervention phases in U/I
Measured: 7 months
Folates levels
Measurement of folate levels change from the beginning to the end of each of the two intervention phases in ng/mL
Measured: 7 months
Vitamin B12 levels
Measurement of vitamin B12 levels change from the beginning to the end of each of the two intervention phases in pg/mL
Measured: 7 months
Urea levels
Measurement of urea levels change from the beginning to the end of each of the two intervention phases in mg/dL
Measured: 7 months
Creatinine levels
Measurement of creatinine levels change from the beginning to the end of each of the two intervention phases in mg/dL
Measured: 7 months
Body weight
Measurement of body weight change from the beginning to the end of each of the two intervention phases in kg
Measured: 7 months
Body mass index (BMI)
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
Measured: 7 months
Fat mass
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).
Measured: 7 months
Concentration of ghrelin in plasma
Measurement of ghrelin change from the beginning to the end of each of the two intervention phases in pg/mL
Measured: 7 months
Concentration of leptin in plasma
Measurement of leptin change from the beginning to the end of each of the two intervention phases in ng/mL
Measured: 7 months
Concentration of adiponectin in plasma
Measurement of adiponectin change from the beginning to the end of each of the two intervention phases in microg/mL
Measured: 7 months
Concentration of resistin in plasma
Measurement of resistin change from the beginning to the end of each of the two intervention phases in ng/mL
Measured: 7 months
Concentration of visfatin in plasma
Measurement of visfatin change from the beginning to the end of each of the two intervention phases in ng/mL
Measured: 7 months
Concentration of interleukin (IL)-4 in plasma
Measurement of IL-4 change from the beginning to the end of each of the two intervention phases in pg/mL
Measured: 7 months
Concentration of interleukin (IL)-6 in plasma
Measurement of IL-6 change from the beginning to the end of each of the two intervention phases in pg/mL
Measured: 7 months
Concentration of interleukin (IL)-10 in plasma
Measurement of IL-10 change from the beginning to the end of each of the two intervention phases in pg/mL
Measured: 7 months
Concentration of Protein C-reactive (PCR) in plasma
Measurement of protein C-reactive (PCR) change from the beginning to the end of each of the two intervention phases in mg/L
Measured: 7 months
Concentration of interferon gamma (IFN-γ) in plasma
Measurement of IFN-γ change from the beginning to the end of each of the two intervention phases in pg/mL
Measured: 7 months
Concentration of tumor necrosis factor -alpha (TNF-α) in plasma
Measurement of TNF-α change from the beginning to the end of each of the two intervention phases in pg/mL
Measured: 7 months
DNA damage expressed as number of DNA strand breaks induced by hydrogen peroxide (H2O2)
Measurement of H2O2-induced DNA strand breaks change from the beginning to the end of each of the two intervention phases in percentage (%)
Measured: 7 months
Concentration of F2-isoprostanes in urine
Measurement of F2-isoprostanes change from the beginning to the end of each of the two intervention phases in pg/mosm
Measured: 7 months
Gut microbiota composition and function changes
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.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study startApr 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florence, University of Teramo
- Responsible party
- Principal investigator, Daniela Martini, University of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314932
- Sponsor's protocol ID
- spe123.23
- Acronym
- PROMENADE
- Status last verified
- Mar 2024
- First submitted
- 1 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39350201
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of ultraPROcessed Foods in Modulating the Effect of mEditerraNeAn Diet on Human and Planet hEalth - the PROMENADE Study
- ClinicalTrials.gov ID
- NCT06314932
- Acronym / sponsor ID
- PROMENADE / spe123.23
- Conditions
- Overweight
- Keywords
- Mediterranean diet, Food processing, Human health, Sustainability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of MilanUniversity, hospital or other
- Collaborators
- University of Florence, University of Teramo
- Study start
- Apr 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High UPF | Experimental | Other: MD high in UPF, Other: MD low in UPFGroup starting with the Mediterranean diet (MD) high in ultra-processed foods (UPF) |
| Low UPF | Active comparator | Other: MD high in UPF, Other: MD low in UPFGroup starting with the Mediterranean diet (MD) low in ultra-processed foods (UPF) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MD high in UPFA 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 | High UPF, Low UPF |
| MD low in UPFA 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) | Other | High UPF, Low UPF |
Primary outcome
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
29 secondary outcomes
Total cholesterol levels
Time frame: 7 months
High-density lipoprotein (HDL) cholesterol levels
Time frame: 7 months
Triglycerides levels
Time frame: 7 months
Fasting blood glucose levels
Time frame: 7 months
Insulin levels
Time frame: 7 months
Aspartate aminotransferase (AST) levels
Time frame: 7 months
Alanine aminotransferase (ALT) levels
Time frame: 7 months
Gamma-glutamyl transferase (GGT) levels
Time frame: 7 months
Folates levels
Time frame: 7 months
Vitamin B12 levels
Time frame: 7 months
Urea levels
Time frame: 7 months
Creatinine levels
Time frame: 7 months
Body weight
Time frame: 7 months
Body mass index (BMI)
Time frame: 7 months
Fat mass
Time frame: 7 months
Concentration of ghrelin in plasma
Time frame: 7 months
Concentration of leptin in plasma
Time frame: 7 months
Concentration of adiponectin in plasma
Time frame: 7 months
Concentration of resistin in plasma
Time frame: 7 months
Concentration of visfatin in plasma
Time frame: 7 months
Concentration of interleukin (IL)-4 in plasma
Time frame: 7 months
Concentration of interleukin (IL)-6 in plasma
Time frame: 7 months
Concentration of interleukin (IL)-10 in plasma
Time frame: 7 months
Concentration of Protein C-reactive (PCR) in plasma
Time frame: 7 months
Concentration of interferon gamma (IFN-γ) in plasma
Time frame: 7 months
Concentration of tumor necrosis factor -alpha (TNF-α) in plasma
Time frame: 7 months
DNA damage expressed as number of DNA strand breaks induced by hydrogen peroxide (H2O2)
Time frame: 7 months
Concentration of F2-isoprostanes in urine
Time frame: 7 months
Gut microbiota composition and function changes
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Derived from this study: PubMed 39350201Dinu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MD high in UPF and MD low in UPF in people with Overweight, run by University of Milan at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniela Martini (+39 02503 16727, daniela.martini@unimi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low-density lipoprotein (LDL) cholesterol levels (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06314932, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.