Impact of MEditerranean Diet, Inflammation and Microbiome After an Acute Coronary Syndrome

NCT03842319 | Completed DMC

• 1 other identifier: CIBER-MEDIMACS
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In the MEDIMACS project, the investigators will use a randomized clinical-trial design to address the effects of mediterranean diet on atherosclerotic plaque vulnerability and coronary endothelial function in order to decipher complex interplays between diet, microbiome, immunological and metabolic responses and coronary atherosclerosis. The investigators will focus on patients after an episode of acute coronary syndrome and use state-of-the-art techniques to address atherosclerotic plaque composition and coronary endothelial function. A number of different -omic approaches will be used to address effector pathways. The insights provided by this study will allow identifying potential new dietary, microbiota and/or metabolic targets for the treatment of atherosclerosis

Conditions

Acute Coronary Syndrome

Keywords

Atherosclerosis; Mediterranean diet; microbiota; immune system; metabolome; proteome

Outcome Measures

Primary Outcomes (1)

• Fibrous cap thickness change

  Change in the thickness of the fibrous layer of the atheroma plaque in the non-culprit vessel measured by optical coherence tomography at 12 months.

  12 months

Secondary Outcomes (10)

• Endothelial dysfunction

  12 months

• Intestinal microbiota composition changes

  12 months

• Oral microbiota composition changes

  12 months

• Adaptive immune system status changes

  12 months

• Innate immune system status changes

  12 months

Study Arms (2)

Control

EXPERIMENTAL

In patients allocated to the control group, the currently used Spanish Mediterranean diet will be recommended as part of a standard high-quality secondary prevention program, where the patient is invited to participate in a single 45 minute nutritional educational group session. Interventions: Microbiota analysis, Immunological analysis, Proteome analysis, Metabolome analysis, Clinical evaluation

Other: Microbiota analysis; Other: Immunological analysis; Other: Proteome analysis; Other: Metabolome analysis; Other: Clinical evaluation; Other: Diet evaluation

High-intensity MedDiet

EXPERIMENTAL

Patients allocated to the interventional group will be individually evaluated by a dietitian and will participate in dedicated individual and group sessions at baseline, and at 3, 6, 9 and 12 months. In the interventional group, a personalized MedDiet will assess chemical and nutritional composition and total energy intake will be adapted to participant's weight, age, and requirements, and the dietitian's tailored advice to his/her individual needs. A 14-item dietary screen for adherence to the Mediterranean diet will be used to personalize the intervention and negotiate dietary changes. Furthermore, free virgin olive oil, recipes, shopping list and designed weekly menus will be provided to maximize the differences between groups. Interventions: MedDiet, Microbiota analysis, Immunological analysis, Proteome analysis, Metabolome analysis, Clinical evaluation, Diet evaluation

Other: Microbiota analysis; Other: Immunological analysis; Other: Proteome analysis; Other: Metabolome analysis; Other: Clinical evaluation; Other: Diet evaluation; Other: MedDiet

Interventions

Microbiota analysis OTHER

From the feces and oral cavity samples, the DNA of the microbiota will be extracted using specific extraction kits and the microbiome will be analyzed through the study of 16S ribosomal RNA amplicons.

Control; High-intensity MedDiet

Immunological analysis OTHER

A study of immunological cell populations, inmunogenetics and cytokines will be carried out from fresh blood samples using antibody panels and flow cytometry

Control; High-intensity MedDiet

Proteome analysis OTHER

A study of host and microbiota proteome will be carried out from samples using mass spectrometry

Control; High-intensity MedDiet

Metabolome analysis OTHER

A study of host and microbiota metabolome will be carried out from samples using MS-based as well as NMR-based methods

Control; High-intensity MedDiet

Clinical evaluation OTHER

Clinical evaluation including hemostasis and biochemical studies

Control; High-intensity MedDiet

Diet evaluation OTHER

Biochemical analysis and questionaries for diet adherence and exercise registration

Control; High-intensity MedDiet

MedDiet OTHER

The high-intensity Mediterranean diet will include the promotion of the following: a) abundant use of olive oil (\>40 g/d) for cooking and dressing dishes; b) consumption of \>2 daily servings of vegetables; c) \>2-3 daily serving of fresh fruits; d) \>3 weekly servings of legumes; e) \>3 weekly servings of fish or seafood; f) \>1 weekly serving of nuts or seeds; g) select white meats instead of red meats or processed meats; and h) cook regularly with tomato, garlic and onion adding or no other aromatic herbs, and dress vegetables, pasta, rice and other dishes with tomato, garlic and onion adding or no other aromatic herbs. Two main meals per day should be eaten (seated at a table, lasting more than 20 minutes). A recommendation to drink a glass of wine per day during meals is given. Limited consumption is advised for cured ham, red meat, chocolate, cured or fatty cheeses

High-intensity MedDiet

Eligibility Criteria

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

You may qualify if:

• Adult patients undergoing cardiac catheterization for an acute coronary syndrome.
• At least 1 non-causal lesion in a coronary segment with a stenosis diameter between 40-70% that will not be submitted to intervention during the revascularization procedure.
• Disposition and possibility to modify the diet.
• With the ability to track and answer questionnaires.
• Signature of informed consent for the study

You may not qualify if:

• TIMI score \<3 in the injury
• Reference lesion with diameter \<2.0 mm
• LV ejection fraction (EF) less than 45%.
• Active systemic infection
• Active periodontal disease
• Chronic inflammatory disease
• Active treatment with corticosteroids or immunomodulators
• Renal insufficiency with glomerular filtration less than 30 mL / min
• Severe hepatic insufficiency (liver cirrhosis in Child B or C stages).
• Comorbidity with life expectancy of less than one year

Sponsors & Collaborators

• Consorcio Centro de Investigación Biomédica en Red (CIBER): lead
• Hospital General Universitario Gregorio Marañon: collaborator
• Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana: collaborator
• University of Navarra: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Tel Aviv University: collaborator
• Göteborg University: collaborator

Study Sites (1)

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Related Publications (1)

• Fernandez AI, Bermejo J, Yotti R, Martinez-Gonzalez MA, Mira A, Gophna U, Karlsson R, Al-Daccak R, Martin-Demiguel I, Gutierrez-Ibanes E, Charron D, Fernandez-Aviles F; MEDIMACS research team. The impact of Mediterranean diet on coronary plaque vulnerability, microvascular function, inflammation and microbiome after an acute coronary syndrome: study protocol for the MEDIMACS randomized, controlled, mechanistic clinical trial. Trials. 2021 Nov 12;22(1):795. doi: 10.1186/s13063-021-05746-z.

  PMID: 34772433 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Atherosclerosis

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Francisco Fernández-Avilés, Professor

  CIBER, HGUGM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Non-intervention or MedDiet intensive intervention group assignment will be made through an automated system. Each patient will be assigned a patient identification number that should appear on all eCRF pages (electronic "case report"), source documents and laboratory data. All researchers involved in the measurement of data, analysis and allocation of results will be blind. The MedDiet intensive intervention will be blind to the evaluation of the endpoints (the research team in charge of the measurement, analysis and awarding of the results will be blind). The samples will be coded and anonymously analyzed by each research team
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Intervention Group: High intensity Mediterranean diet in secondary prevention after acute coronary syndrome. Control Group: recommendation of a standard of care, standard Mediterranean diet. Duration of the intervention per participant: 12 months. Follow-up period per participant: 12 months.

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 15, 2019
• Study Start: May 14, 2019
• Primary Completion: August 2, 2022
• Study Completion: August 2, 2022
• Last Updated: October 3, 2022

Record last verified: 2022-09

Locations

ES (1)