Functional Milk Supplementation to Reduce In-Stent Restenosis in STEMI Patients (SMASOEA Trial)

NCT07176104 | Not Yet Recruiting DMC

• 1 other identifier: SMASOEA-STEMI-FM01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, double-blind, controlled clinical trial will evaluate the effects of daily supplementation with functionalized bovine milk, enriched with bioactive peptides and optimized lipid profile, on coronary in-stent restenosis and major adverse cardiovascular events (MACE) in patients with first ST-elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI) and drug-eluting stent (DES) implantation. Participants will be randomly assigned to receive either functionalized milk or an isocaloric non-functional milk for 12 months, in addition to standard secondary prevention care. The primary endpoint is the incidence of in-stent restenosis at 12 months, assessed by coronary computed tomography angiography (CCTA). Secondary endpoints include MACE occurrence, metabolic and inflammatory biomarkers, oxidative stress markers, serum sirtuins, metabolomic profiles, and myocardial injury evaluated by cardiac positron emission tomography (PET). The study aims to determine whether functionalized milk can improve cardiovascular outcomes and modulate pathophysiological mechanisms after STEMI.

Conditions

ST-elevation Myocardial Infarction (STEMI); In-stent Restenosis

Keywords

ST-Elevation Myocardial Infarction; Inflammation

Outcome Measures

Primary Outcomes (2)

• Incidence of In-Stent Restenosis at 12 Months

  Proportion of patients presenting in-stent restenosis (ISR) as assessed by coronary computed tomography angiography (CCTA) at 12 months after index percutaneous coronary intervention (PCI) with drug-eluting stent.

  12 months after PCI

• Major Adverse Cardiovascular Events (MACE)

  Composite endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and hospitalization for heart failure.

  12 months after PCI

Secondary Outcomes (8)

• Change in Inflammatory Biomarkers

  12 months after PCI

• Change in Oxidative Stress Parameters

  12 months after PCI

• Change in Serum Sirtuin Levels

  12 months after PCI

• Metabolomic Profile Changes

  12 months after PCI

• Cardiac PET Imaging Parameters

  12 months after PCI

Study Arms (2)

Functional Milk Group

EXPERIMENTAL

Participants will receive daily supplementation with functionalized bovine milk enriched with bioactive peptides and optimised lipid profile, in addition to guideline-directed secondary prevention therapy, for 12 months.

Dietary Supplement: Functional Bovine Milk

Non-Functional Milk Group

EXPERIMENTAL

Participants will receive daily supplementation with an isocaloric non-functional bovine milk matched in appearance, taste, and packaging to the functionalized milk, in addition to guideline-directed secondary prevention therapy, for 12 months.

Dietary Supplement: Non-Functional Bovine Milk

Interventions

Non-Functional Bovine Milk DIETARY_SUPPLEMENT

Standard bovine milk with identical caloric and macronutrient profile to the functionalized milk, without enrichment, provided daily for 12 months.

Non-Functional Milk Group

Functional Bovine Milk DIETARY_SUPPLEMENT

Functional milk product enriched with standardised bioactive peptides, provided daily for 12 months.

Functional Milk Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years
• First ST-elevation myocardial infarction (STEMI) treated with percutaneous coronary intervention (PCI) and drug-eluting stent implantation within the previous 4 weeks
• Stable clinical condition at enrollment
• Willingness to adhere to study procedures and dietary supplementation for 12 months
• Signed informed consent

You may not qualify if:

• Previous myocardial infarction or coronary revascularization
• Cardiogenic shock or severe heart failure (NYHA class IV)
• Severe renal impairment (eGFR \<30 mL/min/1.73m²) or dialysis
• Active malignancy or life expectancy \<1 year
• Known lactose intolerance or allergy to milk proteins
• Participation in another interventional clinical trial in the last 30 days

Sponsors & Collaborators

• Raffaele Marfella: lead
• Ministry of Health, Italy: collaborator

Study Sites (1)

Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento di Scienze Mediche e Chirurgiche Avanzate

Naples, 80138, Italy

Location

Related Publications (3)

• Astrup A, Magkos F, Bier DM, Brenna JT, de Oliveira Otto MC, Hill JO, King JC, Mente A, Ordovas JM, Volek JS, Yusuf S, Krauss RM. Saturated Fats and Health: A Reassessment and Proposal for Food-Based Recommendations: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Aug 18;76(7):844-857. doi: 10.1016/j.jacc.2020.05.077. Epub 2020 Jun 17.

  PMID: 32562735 RESULT

• Lamarche B, et al. Dairy products and cardiovascular health: How strong is the evidence? J Am Coll Cardiol. 2016;67(12):1472-1489. doi:10.1016/j.jacc.2015.06.079. PMID: 27012404.

  RESULT

• Lordan R, Tsoupras A, Zabetakis I. Milk and dairy consumption: A review of cardiovascular health benefits and risks. Nutrients. 2018;10(8):993. doi:10.3390/nu10080993. PMID: 30087292.

  RESULT

Related Links

• Università degli Studi della Campania "Luigi Vanvitelli"
• Ministero dell'Agricoltura, della Sovranità Alimentare e delle Foreste (MASAF)
• National Institutes of Health

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Inflammation

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

raffaele Male (M) Marfella, MD, PhD

CONTACT

+390815664174; raffaele.marfella@unicampania.it

raffaele Sardu, MD, PhD

CONTACT

+393391639624; celestino.sardu@unicampania.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind design. Participants, care providers, investigators, and outcomes assessors will be unaware of product allocation. Milk products will be packaged identically and coded by an independent pharmacist/dietary unit.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Two-arm, randomized, double-blind, controlled trial comparing functionalized milk versus non-functional milk in post-STEMI patients.

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: September 16, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

IT (1)