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NCT Number: NCT06051461

Deciphering the Role of Dietary Fatty Acids on Extracellular Vesicles-mediated Intercellular Communication

Dietary interventions have been consistently proposed as a part of a comprehensive strategy to lower the incidence and severity of atherosclerosis and coronary vascular disease. Excessive comsumption of fats enriched in saturated fatty acids (SFAs) is associated with an increased risk of atherosclerosis and other cardiovascular diseases (CVD). In contrasts, replacement of SFAs with monounsaturated fatty acids (MUFAs) and omega-3 long chain polyunsaturated fatty acids (ω3-LCPUFAs) has been reported to be inversely associated with risk of atherosclerosis. This is partly due to the ability of MUFAs (and ω3-LCPUFAs) to modulate lipoprotein composition, oxidation state, and consequently their functionality, among others. While most of the nutritional studies have focused on elucidating the mechanisms by which dietary fats affect lipoprotein particles, little or nothing is known about the regulatory effect of dietary fatty acids on extracellular vesicles (EVs). EVs are small phospholipid particles that convey molecular bioactive cargoes and play essential roles in intercellular communication and, hence, a multifaceted role in health and disease. For the first time, the purpose of this project is to establish whether the type of major fatty acids present on a diet (SFAs, MUFAs, or ω3-LCPUFAs) may alter the structure, cargo, and functionality of postprandial- and long-term-EVs. In the precision nutrition era, the investigators expect to offer a new insight on EVs and their relationship with dietary fatty acids through the following objectives: 1) To map changes in the lipidome, proteome, microtranscriptome, and functional properties of circulating EVs in healthy subjects and patients with metabolic syndrome (MetS) both at fasting and at postprandial state upon a challenge of a meal rich in SFAs, MUFAs, and ω3-LCPUFAs; 2) To analyse the contribution of postprandial triacylglyceride-rich lipoproteins (TRL) on EVs-mediated intercellular communication in a fatty acid-dependent manner; and 3) To determine the influence of diets rich in SFAs, MUFAs, and ω3-LCPUFAs on EVs in an animal model of atherosclerosis in the setting of MetS. Collectively, this project will provide fundamental insight into EV biology, and remarks the clinical and functional relevance and divergent consequences of dietary fatty acids in health and disease.

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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Immune System and Related Disorders Inflammation Insulin Resistance Metabolic Diseases Metabolic Disorder Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Seville

Seville, 41009, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of metabolic syndrome

Exclusion criteria

  • Allergy to dairy products
  • Allergy to fish oil
  • Vegetarian
  • Tobacco smoker
  • Current or recent (<4 wk) use of fish oil supplements or more than four times fish/week
  • Received innoculations within 2 mo of starting the study or planned to during the study
  • Donated or intended to donate blood from 2 mo before the study till 2 mo after the study
  • Unstable body weight (no weight gain/loss >3 kg)

Treatment and study plan

Oral lipid emulsions

Dietary Supplement

The oral lipid emulsions will contain water, sucrose, emulsifier, flavouring, and the corresponding fat (50 g/m2 of body surface area): milk cream (SFAs) or refined olive oil (MUFAs) with or without a dose of omega-3 PUFA, which will consist of 920 mg of EPA and 760 mg of DHA (ω3-LCPUFAs).

Primary outcomes

  1. Evolution of cytokines in postprandial state

    Time frame: Up to 6 hours

    Pro-inflammatory and anti-inflammatory cytokines, including NFα, IL-1β, IL-6, IL-8, IL-10, ICAM-1, MCP-1, leptin, and adiponectin, in plasma will be measured using appropriate methods (EIA, ELISA, and/or Bioplex multiplex system) (mg/dl).

  2. Evolution of inflammatory markers in postprandial state. [Time Frame: Up to 6 hours]

    Time frame: Up to 6 hours

    The acute phase protein (hsCRP), PAI-1, fibrinogen, transferrin, albumin, and myeloperoxidase (MPO) will be measured using appropriate methods (EIA, ELISA, and/or Bioplex multiplex system) (mg/dl).

  3. Effect of EVs on gene expression in PBMCs

    Time frame: Up to 6 hours

    PBMCs will be isolated from the subjects' peripheral blood and treated with autologous circulating EVs for different times.

  4. EV proteome

    Time frame: Up to 6 hours

    The quantification of exosome-derived proteins will be performed by nLC-MS/MS

  5. EV lipidome

    Time frame: Up to 6 hours

    The analysis of intact lipids derived from exosomes will be performed by LC-MS

  6. Ev microtranscriptome

    Time frame: Up to 6 hours

    Enriched RNA and miRNA derived from exosomes will be determined by Next Generation Sequencing (NGS)

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Collaborators

  • Spanish National Research Council

Registry information

Official study title

Deciphering the Role of Dietary Fatty Acids on Extracellular Vesicles-mediated Intercellular Communication and Their Implication in Atherosclerosis and Metabolic Syndrome: a Multi-omics Approach to Precision Nutrition

Acronym: DIETEVOME

Important dates

Study start
2023
Primary completion
2024
Study completion
2027
First posted
Sep 25, 2023
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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