- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06051461
Deciphering the Role of Dietary Fatty Acids on Extracellular Vesicles-mediated Intercellular Communication (DIETEVOME)
September 19, 2023 updated by: Sergio Montserrat de la Paz, University of Seville
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
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seville, Spain, 41009
- University of Seville
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Healthy patients
|
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).
|
Active Comparator: Metabolic Syndrome patients
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
Up to 6 hours
|
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).
|
Up to 6 hours
|
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.
|
Up to 6 hours
|
EV proteome
Time Frame: Up to 6 hours
|
The quantification of exosome-derived proteins will be performed by nLC-MS/MS
|
Up to 6 hours
|
EV lipidome
Time Frame: Up to 6 hours
|
The analysis of intact lipids derived from exosomes will be performed by LC-MS
|
Up to 6 hours
|
Ev microtranscriptome
Time Frame: Up to 6 hours
|
Enriched RNA and miRNA derived from exosomes will be determined by Next Generation Sequencing (NGS)
|
Up to 6 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
November 1, 2023
Primary Completion (Estimated)
September 1, 2024
Study Completion (Estimated)
September 1, 2027
Study Registration Dates
First Submitted
September 5, 2023
First Submitted That Met QC Criteria
September 19, 2023
First Posted (Actual)
September 25, 2023
Study Record Updates
Last Update Posted (Actual)
September 25, 2023
Last Update Submitted That Met QC Criteria
September 19, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- US
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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