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

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

Interventions

OTHER

Microbiota analysis

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.

OTHER

Immunological analysis

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

OTHER

Proteome analysis

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

OTHER

Metabolome analysis

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

OTHER

Clinical evaluation

Clinical evaluation including hemostasis and biochemical studies

OTHER

Diet evaluation

Biochemical analysis and questionaries for diet adherence and exercise registration

OTHER

MedDiet

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

Sponsors & Collaborators

• Hospital General Universitario Gregorio Marañon

  collaborator OTHER

• Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

  collaborator OTHER

• University of Navarra

  collaborator OTHER

• Institut National de la Santé Et de la Recherche Médicale, France

  collaborator OTHER_GOV

• Tel Aviv University

  collaborator OTHER

• Göteborg University

  collaborator OTHER

• Consorcio Centro de Investigación Biomédica en Red (CIBER)

  lead OTHER_GOV

Principal Investigators

• Francisco Fernández-Avilés, Professor · CIBER, HGUGM

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-05-14

Primary Completion

2022-08-02

Completion

2022-08-02

Countries

• Spain

Study Locations