ObesityDIETEVOMENCT06051461
Deciphering the Role of Dietary Fatty Acids on Extracellular Vesicles-mediated Intercellular Communication
A study testing Oral lipid emulsions in people with Obesity and Metabolic Syndrome, run by University of Seville at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Metabolic Syndrome, Metabolic Disorder
- What is being tested?
- Oral lipid emulsions
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2023to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of metabolic syndrome
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Obesity, Metabolic Syndrome, Metabolic Disorder, Inflammation, Immune System and Related Disorders
- Being tested
- Oral lipid emulsions
- Medical subject headings
- Obesity, Metabolic Syndrome, Metabolic Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral lipid emulsionsDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| Metabolic Syndrome patients | Active comparator | Not described Receives: Dietary Supplement: Oral lipid emulsions |
| Healthy patients | Experimental | Not described Receives: Dietary Supplement: Oral lipid emulsions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of cytokines in postprandial state
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).
Measured: Up to 6 hours
Evolution of inflammatory markers in postprandial state. [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).
Measured: Up to 6 hours
Effect of EVs on gene expression in PBMCs
PBMCs will be isolated from the subjects' peripheral blood and treated with autologous circulating EVs for different times.
Measured: Up to 6 hours
EV proteome
The quantification of exosome-derived proteins will be performed by nLC-MS/MS
Measured: Up to 6 hours
EV lipidome
The analysis of intact lipids derived from exosomes will be performed by LC-MS
Measured: Up to 6 hours
Ev microtranscriptome
Enriched RNA and miRNA derived from exosomes will be determined by Next Generation Sequencing (NGS)
Measured: Up to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start1 Nov 2023
- Primary completion1 Sep 2024
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish National Research Council
- Responsible party
- Principal investigator, Sergio Montserrat de la Paz, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051461
- Sponsor's protocol ID
- US
- Acronym
- DIETEVOME
- Status last verified
- Jul 2025
- First submitted
- 5 Sep 2023
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Marquez-Paradas E, Gil-Sanchez G, Barrera-Chamorro L, Gonzalez-de la Rosa T, Miguel-Albarreal AD, Corell A, Montserrat-de la Paz S. Postprandial modulation of the surface profile and cellular origin of circulating extracellular vesicles by dietary fatty acid composition: A randomized crossover pilot study in young healthy adults. Clin Nutr. 2026 Jan;56:106539. doi: 10.1016/j.clnu.2025.11.023. Epub 2025 Dec 6.
PubMed 41406627
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06051461
- Acronym / sponsor ID
- DIETEVOME / US
- Conditions
- Obesity, Metabolic Syndrome, Metabolic Disorder, Inflammation, Immune System and Related Disorders
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Collaborators
- Spanish National Research Council
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 25 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metabolic Syndrome patients | Active comparator | Dietary Supplement: Oral lipid emulsions |
| Healthy patients | Experimental | Dietary Supplement: Oral lipid emulsions |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of metabolic syndrome
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral lipid emulsionsThe 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). | Dietary supplement | Healthy patients, Metabolic Syndrome patients |
Primary outcome
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).
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).
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.
EV proteome
Time frame: Up to 6 hours
The quantification of exosome-derived proteins will be performed by nLC-MS/MS
EV lipidome
Time frame: Up to 6 hours
The analysis of intact lipids derived from exosomes will be performed by LC-MS
Ev microtranscriptome
Time frame: Up to 6 hours
Enriched RNA and miRNA derived from exosomes will be determined by Next Generation Sequencing (NGS)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Derived from this study: PubMed 41406627Marquez-Paradas E, Gil-Sanchez G, Barrera-Chamorro L, Gonzalez-de la Rosa T, Miguel-Albarreal AD, Corell A, Montserrat-de la Paz S. Postprandial modulation of the surface profile and cellular origin of circulating extracellular vesicles by dietary fatty acid composition: A randomized crossover pilot study in young healthy adults. Clin Nutr. 2026 Jan;56:106539. doi: 10.1016/j.clnu.2025.11.023. Epub 2025 Dec 6.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral lipid emulsions in people with Obesity and Metabolic Syndrome, run by University of Seville at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of cytokines in postprandial state (time frame: Up to 6 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06051461, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.