NCT03842319

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

Impact of MEditerranean Diet, Inflammation and Microbiome on Plaque Vulnerability and Microvascular Dysfunction After an Acute Coronary Syndrome. A Randomized, Controlled, Mechanistic Clinical Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Consorcio Centro de Investigación Biomédica en Red (CIBER) · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Coronary atherosclerosis is a leading cause of mortality and disability worldwide. Continuous efforts are needed to improve secondary prevention and understand the mechanism underlying disease progression. Based on primary prevention trials, a potential benefit of the Mediterranean diet after an acute coronary syndrome can be anticipated. The integrated microbiome-mediated/ immunologic and metabolic pathways by which the Mediterranean diet modifies cardiovascular risk remain mostly unknown. Intestinal and oral dysbiosis is involved in the pathogenesis of atherosclerosis and microbiome dynamics may account for some of the observed benefits of Mediterranean diet. The first objective of the trial is to evaluate the effects of a well-controlled Mediterranean diet intervention on atherosclerotic plaque vulnerability and coronary endothelial dysfunction after an episode of acute coronary syndrome. The second objective is to decipher the interplays among diet, microbiota, immunity and metabolism responsible for the observed effects. The investigators propose a randomized mechanistic clinical trial, using state-of-the-art efficacy read-outs. The multidisciplinary consortium includes highly experienced cardiologists, nutritionists and experts in translational research in immunology, microbiomics, genomics, proteomics, metabolomics and metagenomics. This study will provide valuable insights to identify potential microbiome therapeutic targets for coronary artery disease.

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-05-14
• Primary completion: 2022-08-02
• Completion: 2022-08-02
• First posted: 2019-02-15
• Last updated: 2022-10-03

Locations

1 site across 1 country: Spain