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

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

May 14, 2019

Primary Completion Date

August 2, 2022

Study Completion Date

August 2, 2022

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

Trial Locations (1)

28007

Hospital General Universitario Gregorio Marañón, Madrid

All Listed Sponsors
collaborator

Hospital General Universitario Gregorio Marañon

OTHER

collaborator

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

OTHER

collaborator

University of Navarra

OTHER

collaborator

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

OTHER_GOV

collaborator

Tel Aviv University

OTHER

collaborator

Göteborg University

OTHER

lead

Consorcio Centro de Investigación Biomédica en Red (CIBER)

OTHER_GOV

NCT03842319 - Impact of MEditerranean Diet, Inflammation and Microbiome After an Acute Coronary Syndrome | Biotech Hunter | Biotech Hunter