Atherosclerosis Cardiovascular Disease(WINEVOME)NCT07361887
Deciphering the Effect of Moderate Wine Consumption on Healthy Aging Through Postprandial Extracellular Vesicles.
A study testing White Wine, Red Wine and Water in people with Atherosclerosis Cardiovascular Disease and Obesity, run by University of Seville at 1 site in Spain.
Trial summary
This study aims to investigate how moderate wine consumption influences circulating extracellular vesicles (EVs) in healthy adults. EVs are small particles released by cells that carry proteins, lipids, and genetic material, and play important roles in communication between cells. Read more about this study
- Who is it for?
- Ages 35 to 36 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis Cardiovascular Disease, Obesity, Metabolic Syndrome
- What is being tested?
- White Wine, Red Wine and Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteSpain
- Study dates
- 1 Nov 2025to 31 Mar 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 36 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult men and women aged 35 to 65 years.
- Body Mass Index (BMI) between 18.5 and 29.9 kg/m².
- Non-smokers or ex-smokers for at least 12 months.
- Moderate alcohol consumers, defined as ≤2 units/day for men and ≤1 unit/day for women.
- Normal fasting glucose and lipid profile at screening.
- Willing and able to refrain from alcohol, polyphenol-rich foods, and intense exercise for 48 hours before each study visit.
- Able to understand the study procedures and provide written informed consent.
Who cannot join
- History or clinical evidence of cardiovascular, hepatic, renal, thyroid, gastrointestinal, or metabolic diseases (including diabetes, dyslipidemia, or hypertension).
- Use of medications or supplements known to affect glucose, lipid, or inflammatory metabolism (e.g., statins, corticosteroids, anti-inflammatory drugs).
- Pregnancy or breastfeeding.
- Recent blood donation (within the last 3 months) or planned blood donation during the study period.
- Major weight change (>5% of body weight) within the last 3 months.
- Participation in another clinical or biomedical study within the previous 3 months.
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- Known allergy or intolerance to wine, alcohol, or its components (e.g., sulfites).
- History of alcohol abuse or inability to abstain from alcohol outside the study context.
- Reluctance to receive information about incidental health findings arising from the study.
- Any condition judged by the investigators to limit compliance or increase study risk (e.g., psychiatric disorders, inability to adhere to fasting requirements).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Av. de Sánchez Pizjuán, s/n, 41009 Sevilla Facultad de Medicina . Universidad de Sevilla
Seville, Sevilla, 41009
Sergio Montserrat de la Paz, Full Professor, +34 605383541, delapaz@us.es
About this study
Official title: Deciphering the Effect of Moderate Wine Consumption on Healthy Aging Through Postprandial Extracellular Vesicles
This study aims to investigate how moderate wine consumption influences circulating extracellular vesicles (EVs) in healthy adults. EVs are small particles released by cells that carry proteins, lipids, and genetic material, and play important roles in communication between cells. Participants will consume a single serving of red or white wine, and blood samples will be collected before and after consumption to study changes in the composition and function of EVs. The study will also assess how these EVs affect vascular, immune, and brain-related cells. The results are expected to improve our understanding of how moderate wine intake contributes to cardiovascular and brain health.
Read the detailed description
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. According to the Dietary Guidelines for Americans 2015-2020, moderate red wine consumption-defined as up to two units of alcohol per day for men and up to one unit of alcohol per day for women-significantly reduces the risk of cardiovascular disease (CVD). Wine is a complex matrix consisting primarily of water (86%) and ethyl alcohol (12%), as well as other different molecules, such as polyphenols, organic acids, tannins, compound minerals, vitamins and biologically active compounds. While most of the nutritional studies have focused on elucidating the mechanisms by which biologically active compounds directly affect cardiovascular-related events, little or nothing is known about the regulatory effect of wine consumption 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. Recent advances in research on EVs have significantly enhanced their potential as therapeutic agents for neurological diseases. Owing to their therapeutic properties and ability to cross the blood-brain barrier (BBB), extracellular vesicles are recognized as promising drug delivery vehicles (e.g. polyphenols) for various neurological conditions. For the first time, the purpose of this project is to establish whether the moderate wine consumption may alter the structure, cargo, and functionality of postprandial EVs. In the precision nutrition era, we expect to offer a new insight on EVs and their relationship with wine through the following objectives: 1) To map changes in the lipidome, proteome, polyphenolic cargo, and functional properties of circulating EVs in healthy subjects both at fasting and at postprandial state upon a challenge of a one unit of red or white wine; 2) To analyse the effect of postprandial EVs on atherosclerotic-related events in endothelial and immune cells. 3) To analyse the effect of postprandial EVs on healthy ageing in blood-brain barrier and microglial cells. Collectively, this project will provide fundamental insight into EV biology and remarks the clinical and functional relevance and consequences of moderate wine consumption in health and disease.
- Conditions
- Atherosclerosis Cardiovascular Disease, Obesity, Metabolic Syndrome, Metabolic Disorders, Inflammation, Neurodegeneration
- Being tested
- White Wine, Red Wine, Water
- Keywords
- blood-brain barrier, microglia, extracellular vesicles, lipidome, proteome, vascular disease
- Medical subject headings
- Obesity, Metabolic Syndrome, Metabolic Diseases, Inflammation, Nerve Degeneration, Neurodegenerative Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White WineDietary supplement
Chardonnay, 4 mL/kg body weight
Red WineDietary supplement
Cabernet Sauvignon, 4 mL/kg body weight
WaterDietary supplement
Still water, 4 mL/kg body weight
| Study group | Role | What they receive |
|---|---|---|
| Red Wine | Experimental | Participants will consume red wine (Cabernet Sauvignon) at a dose of 4 mL per kg body weight within 15 minutes. Blood samples will be collected at fasting (0 h), postprandial peak (1-2 h), and post-peak (6 h). Receives: Dietary Supplement: Red Wine |
| White Wine | Experimental | Participants will consume white wine (Chardonnay) at a dose of 4 mL per kg body weight within 15 minutes. Blood samples will be collected at fasting (0 h), postprandial peak (1-2 h), and post-peak (6 h). Receives: Dietary Supplement: White Wine |
| Water (Control) | Placebo comparator | Participants will consume water (4 mL per kg body weight) within 15 minutes, serving as the control condition. Blood samples will be collected at fasting (0 h), postprandial peak (1-2 h), and post-peak (6 h). Receives: Dietary Supplement: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of circulating extracellular vesicles
Concentration of plasma-derived extracellular vesicles measured after acute intake of red wine, white wine, or water. Extracellular vesicles will be isolated by immunoaffinity methods and quantified using nanoparticle-based analysis. Results will be expressed as particles per milliliter (particles/mL).
Measured: Baseline (0 hours), postprandial peak (2 hours after beverage intake), and post-peak (6 hours after beverage intake).
Mean size of circulating extracellular vesicles
Mean diameter of plasma-derived extracellular vesicles measured after acute intake of red wine, white wine, or water. Extracellular vesicle size will be assessed using dynamic light scattering. Results will be expressed in nanometers (nm).
Measured: Baseline (0 hours), postprandial peak (2 hours after beverage intake), and post-peak (6 hours after beverage intake).
Secondary outcomes (23)
Postprandial changes in extracellular vesicle proteome
Postprandial changes in the protein composition of plasma-derived extracellular vesicles following acute intake of red wine, white wine, or water. EV-associated proteins will be analyzed using quantitative liquid chromatography-tandem mass spectrometry (LC-MS/MS). Results will be expressed as normalized protein abundance.
Measured: Baseline (0 hours), postprandial peak (2 hours after beverage intake), and post-peak (6 hours after beverage intake).
Postprandial changes in extracellular vesicle lipidome
Postprandial changes in the lipid composition of plasma-derived extracellular vesicles following acute intake of red wine, white wine, or water. EV-associated lipid species will be analyzed using quantitative lipidomics by liquid chromatography-mass spectrometry (LC-MS). Results will be expressed as normalized lipid abundance.
Measured: Baseline (0 hours), postprandial peak (2 hours after beverage intake), and post-peak (6 hours after beverage intake).
Change from baseline in plasma glucose concentration
Venous blood plasma glucose concentration measured using a validated clinical chemistry assay (enzymatic method). Primary metric is change from baseline at each postprandial time point (time point value minus baseline value).
Unit of Measure: mg/dL
Measured: Baseline (0 hours), 2 hours, and 6 hours after beverage intake
Change from baseline in plasma insulin concentration
Venous blood plasma insulin concentration measured using a validated immunoassay. Primary metric is change from baseline at each postprandial time point (time point value minus baseline value).
Unit of Measure: µIU/mL
Measured: Baseline (0 hours), 2 hours, and 6 hours after beverage intake
Change from baseline in plasma triglyceride concentration
Venous blood plasma triglyceride concentration measured using a validated clinical chemistry assay (enzymatic method). Primary metric is change from baseline at each postprandial time point (time point value minus baseline value).
Unit of Measure: mg/dL
Measured: Baseline (0 hours), 2 hours, and 6 hours after beverage intake
Change from baseline in plasma total cholesterol concentration
Venous blood plasma total cholesterol concentration measured using a validated clinical chemistry assay (enzymatic method). Primary metric is change from baseline at each postprandial time point (time point value minus baseline value).
Unit of Measure: mg/dL
Measured: Baseline (0 hours), 2 hours, and 6 hours after beverage intake
Change from baseline in plasma HDL cholesterol concentration
Venous blood plasma HDL cholesterol concentration measured using a validated clinical chemistry assay (enzymatic method). Primary metric is change from baseline at each postprandial time point (time point value minus baseline value).
Unit of Measure: mg/dL
Measured: Baseline (0 hours), 2 hours, and 6 hours after beverage intake
Change from baseline in plasma LDL cholesterol concentration
Venous blood plasma LDL cholesterol concentration measured using a validated clinical chemistry assay (enzymatic method). Primary metric is change from baseline at each postprandial time point (time point value minus baseline value).
Unit of Measure: mg/dL
Measured: Baseline (0 hours), 2 hours, and 6 hours after beverage intake
Change from baseline in plasma interleukin-6 (IL-6) concentration
Venous blood plasma IL-6 concentration measured using a validated immunoassay. Primary metric is change from baseline at each postprandial time point (time point value minus baseline value).
Unit of Measure: pg/mL
Measured: Baseline (0 hours), 2 hours, and 6 hours after beverage intake
Change from baseline in plasma tumor necrosis factor alpha (TNF-α) concentration
Venous blood plasma TNF-α concentration measured using a validated immunoassay. Primary metric is change from baseline at each postprandial time point (time point value minus baseline value).
Unit of Measure: pg/mL
Measured: Baseline (0 hours), 2 hours, and 6 hours after beverage intake
Change from baseline in plasma interleukin-1 beta (IL-1β) concentration
Venous blood plasma IL-1β concentration measured using a validated immunoassay. Primary metric is change from baseline at each postprandial time point (time point value minus baseline value).
Unit of Measure: pg/mL
Measured: Baseline (0 hours), 2 hours, and 6 hours after beverage intake
Change from baseline in plasma monocyte chemoattractant protein-1 (MCP-1/CCL2) concentration
Venous blood plasma MCP-1/CCL2 concentration measured using a validated immunoassay. Primary metric is change from baseline at each postprandial time point (time point value minus baseline value).
Unit of Measure: pg/mL
Measured: Baseline (0 hours), 2 hours, and 6 hours after beverage intake
Transendothelial electrical resistance (TEER) in an in vitro human blood-brain barrier model after exposure to postprandial extracellular vesicles
lood-brain barrier (BBB) integrity assessed by transendothelial electrical resistance (TEER) in a human in vitro BBB model after exposure to extracellular vesicles (EVs) isolated from plasma at baseline (0 hours) and postprandial peak (2 hours).
Unit of Measure: Ω·cm²
Measured: EVs isolated at baseline (0 hours) and 2 hours after beverage intake; TEER assessed within 72 hours after EV isolation
Claudin-5 (CLDN5) protein expression in an in vitro human blood-brain barrier model after exposure to postprandial extracellular vesicles
Tight junction protein expression assessed in the BBB model by Claudin-5 (CLDN5) protein abundance after exposure to EVs isolated at baseline (0 hours) and 2 hours post intake. Protein expression quantified using immunoblotting or immunofluorescence and reported relative to the control condition.
Unit of Measure: Fold change (dimensionless)
Measured: EVs isolated at baseline (0 hours) and 2 hours after beverage intake; protein expression assessed within 72 hours after EV isolation
Occludin (OCLN) protein expression in an in vitro human blood-brain barrier model after exposure to postprandial extracellular vesicles
Tight junction protein expression assessed in the BBB model by occludin (OCLN) protein abundance after exposure to EVs isolated at baseline (0 hours) and 2 hours post intake. Protein expression quantified using immunoblotting or immunofluorescence and reported relative to the control condition.
Unit of Measure: Fold change (dimensionless)
Measured: EVs isolated at baseline (0 hours) and 2 hours after beverage intake; protein expression assessed within 72 hours after EV isolation
Interleukin-6 (IL-6) concentration in microglial culture supernatant after exposure to postprandial extracellular vesicles
Microglial activation assessed by IL-6 concentration in culture supernatant after exposure to EVs isolated at baseline (0 hours) and 2 hours post intake. Cytokine concentration quantified using a validated immunoassay.
Unit of Measure: pg/mL
Measured: EVs isolated at baseline (0 hours) and 2 hours after beverage intake; cytokines assessed within 72 hours after EV isolation
Tumor necrosis factor alpha (TNF-α) concentration in microglial culture supernatant after exposure to postprandial extracellular vesicles
Microglial activation assessed by TNF-α concentration in culture supernatant after exposure to EVs isolated at baseline (0 hours) and 2 hours post intake. Cytokine concentration quantified using a validated immunoassay.
Unit of Measure: pg/mL
Measured: EVs isolated at baseline (0 hours) and 2 hours after beverage intake; cytokines assessed within 72 hours after EV isolation
IL1B mRNA expression in microglia after exposure to postprandial extracellular vesicles
Microglial activation assessed by IL1B mRNA expression after exposure to EVs isolated at baseline (0 hours) and 2 hours post intake. Gene expression quantified by RT-qPCR and reported as relative expression versus control condition.
Unit of Measure: Fold change (dimensionless)
Measured: EVs isolated at baseline (0 hours) and 2 hours after beverage intake; gene expression assessed within 72 hours after EV isolation
Endothelial VCAM-1 protein expression after exposure to postprandial extracellular vesicles
Endothelial activation assessed by VCAM-1 protein expression in cultured human umbilical vein endothelial cells after exposure to extracellular vesicles isolated from plasma at baseline (0 hours) and postprandial peak (2 hours). Protein expression quantified by immunoblotting or immunofluorescence and reported relative to control condition.
Unit of Measure: Fold change (dimensionless)
Measured: EVs isolated at baseline (0 hours) and 2 hours after beverage intake; assays conducted within 48 hours after EV isolation
Polyphenolic content of extracellular vesicles after wine intake
Identification and quantification of polyphenolic compounds encapsulated within plasma-derived extracellular vesicles following acute intake of red wine or white wine. Polyphenols will be analyzed using ultra-high-performance liquid chromatography coupled to quadrupole-Orbitrap mass spectrometry. Results will be expressed as normalized peak areas and concentrations relative to internal standards.
Measured: Baseline (0 hours), postprandial peak (2 hours after beverage intake), and post-peak (6 hours after beverage intake).
Spearman correlation between EV cargo score and change from baseline in plasma glucose concentration
Association assessed using Spearman rank correlation (ρ) between EV cargo score (PC1 derived from normalized EV proteomic and lipidomic features measured by mass spectrometry) and the systemic response measure defined as change from baseline in plasma glucose concentration at postprandial time points. The outcome measure is Spearman's ρ.
Unit of Measure: Spearman's ρ (dimensionless)
Measured: Baseline (0 hours), 2 hours, and 6 hours after beverage intake (plasma glucose); EVs isolated at baseline (0 hours) and 2 hours after beverage intake
Endothelial ICAM-1 protein expression after exposure to postprandial extracellular vesicles
Endothelial activation assessed by ICAM-1 protein expression in cultured human umbilical vein endothelial cells after exposure to extracellular vesicles isolated from plasma at baseline (0 hours) and postprandial peak (2 hours). Protein expression quantified by immunoblotting or immunofluorescence and reported relative to control condition.
Unit of Measure: Fold change (dimensionless)
Measured: EVs isolated at baseline (0 hours) and 2 hours after beverage intake; assays conducted within 48 hours after EV isolation
Nitric oxide (NO) production in endothelial cell culture supernatant after exposure to postprandial extracellular vesicles
Endothelial response assessed by nitric oxide production after exposure to extracellular vesicles isolated from plasma at baseline (0 hours) and postprandial peak (2 hours). NO production quantified in culture supernatant using a validated colorimetric assay (e.g., nitrite/nitrate).
Unit of Measure: µM
Measured: EVs isolated at baseline (0 hours) and 2 hours after beverage intake; assays conducted within 48 hours after EV isolation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Nov 2025
- Primary completion1 Dec 2025
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerosis Cardiovascular DiseaseStudies 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
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sergio Montserrat de la Paz, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361887
- Sponsor's protocol ID
- 2024-2934
- Acronym
- (WINEVOME)
- Status last verified
- Jan 2026
- First submitted
- 2 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deciphering the Effect of Moderate Wine Consumption on Healthy Aging Through Postprandial Extracellular Vesicles
- ClinicalTrials.gov ID
- NCT07361887
- Acronym / sponsor ID
- (WINEVOME) / 2024-2934
- Conditions
- Atherosclerosis Cardiovascular Disease, Obesity, Metabolic Syndrome, Metabolic Disorders, Inflammation, Neurodegeneration
- Keywords
- blood-brain barrier, microglia, extracellular vesicles, lipidome, proteome, vascular disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 23 Jan 2026 (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.
This study aims to investigate how moderate wine consumption influences circulating extracellular vesicles (EVs) in healthy adults. EVs are small particles released by cells that carry proteins, lipids, and genetic material, and play important roles in communication between cells. Participants will consume a single serving of red or white wine, and blood samples will be collected before and after consumption to study changes in the composition and function of EVs. The study will also assess how these EVs affect vascular, immune, and brain-related cells. The results are expected to improve our understanding of how moderate wine intake contributes to cardiovascular and brain health.
Detailed description
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. According to the Dietary Guidelines for Americans 2015-2020, moderate red wine consumption-defined as up to two units of alcohol per day for men and up to one unit of alcohol per day for women-significantly reduces the risk of cardiovascular disease (CVD). Wine is a complex matrix consisting primarily of water (86%) and ethyl alcohol (12%), as well as other different molecules, such as polyphenols, organic acids, tannins, compound minerals, vitamins and biologically active compounds. While most of the nutritional studies have focused on elucidating the mechanisms by which biologically active compounds directly affect cardiovascular-related events, little or nothing is known about the regulatory effect of wine consumption 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. Recent advances in research on EVs have significantly enhanced their potential as therapeutic agents for neurological diseases. Owing to their therapeutic properties and ability to cross the blood-brain barrier (BBB), extracellular vesicles are recognized as promising drug delivery vehicles (e.g. polyphenols) for various neurological conditions. For the first time, the purpose of this project is to establish whether the moderate wine consumption may alter the structure, cargo, and functionality of postprandial EVs. In the precision nutrition era, we expect to offer a new insight on EVs and their relationship with wine through the following objectives: 1) To map changes in the lipidome, proteome, polyphenolic cargo, and functional properties of circulating EVs in healthy subjects both at fasting and at postprandial state upon a challenge of a one unit of red or white wine; 2) To analyse the effect of postprandial EVs on atherosclerotic-related events in endothelial and immune cells. 3) To analyse the effect of postprandial EVs on healthy ageing in blood-brain barrier and microglial cells. Collectively, this project will provide fundamental insight into EV biology and remarks the clinical and functional relevance and consequences of moderate wine consumption in health and disease.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Red Wine | Experimental | Dietary Supplement: Red WineParticipants will consume red wine (Cabernet Sauvignon) at a dose of 4 mL per kg body weight within 15 minutes. Blood samples will be collected at fasting (0 h), postprandial peak (1-2 h), and post-peak (6 h). |
| White Wine | Experimental | Dietary Supplement: White WineParticipants will consume white wine (Chardonnay) at a dose of 4 mL per kg body weight within 15 minutes. Blood samples will be collected at fasting (0 h), postprandial peak (1-2 h), and post-peak (6 h). |
| Water (Control) | Placebo comparator | Dietary Supplement: WaterParticipants will consume water (4 mL per kg body weight) within 15 minutes, serving as the control condition. Blood samples will be collected at fasting (0 h), postprandial peak (1-2 h), and post-peak (6 h). |
Who may qualify
- Ages
- 35 to 36 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy adult men and women aged 35 to 65 years.
- Body Mass Index (BMI) between 18.5 and 29.9 kg/m².
- Non-smokers or ex-smokers for at least 12 months.
- Moderate alcohol consumers, defined as ≤2 units/day for men and ≤1 unit/day for women.
- Normal fasting glucose and lipid profile at screening.
Key exclusion criteria (10 listed)
- History or clinical evidence of cardiovascular, hepatic, renal, thyroid, gastrointestinal, or metabolic diseases (including diabetes, dyslipidemia, or hypertension).
- Use of medications or supplements known to affect glucose, lipid, or inflammatory metabolism (e.g., statins, corticosteroids, anti-inflammatory drugs).
- Pregnancy or breastfeeding.
- Recent blood donation (within the last 3 months) or planned blood donation during the study period.
- Major weight change (>5% of body weight) within the last 3 months.
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 |
|---|---|---|
| White WineChardonnay, 4 mL/kg body weight | Dietary supplement | White Wine |
| Red WineCabernet Sauvignon, 4 mL/kg body weight | Dietary supplement | Red Wine |
| WaterStill water, 4 mL/kg body weight | Dietary supplement | Water (Control) |
Primary outcome
Concentration of circulating extracellular vesicles
Time frame: Baseline (0 hours), postprandial peak (2 hours after beverage intake), and post-peak (6 hours after beverage intake).
Concentration of plasma-derived extracellular vesicles measured after acute intake of red wine, white wine, or water. Extracellular vesicles will be isolated by immunoaffinity methods and quantified using nanoparticle-based analysis. Results will be expressed as particles per milliliter (particles/mL).
Mean size of circulating extracellular vesicles
Time frame: Baseline (0 hours), postprandial peak (2 hours after beverage intake), and post-peak (6 hours after beverage intake).
Mean diameter of plasma-derived extracellular vesicles measured after acute intake of red wine, white wine, or water. Extracellular vesicle size will be assessed using dynamic light scattering. Results will be expressed in nanometers (nm).
23 secondary outcomes
Postprandial changes in extracellular vesicle proteome
Time frame: Baseline (0 hours), postprandial peak (2 hours after beverage intake), and post-peak (6 hours after beverage intake).
Postprandial changes in extracellular vesicle lipidome
Time frame: Baseline (0 hours), postprandial peak (2 hours after beverage intake), and post-peak (6 hours after beverage intake).
Change from baseline in plasma glucose concentration
Time frame: Baseline (0 hours), 2 hours, and 6 hours after beverage intake
Change from baseline in plasma insulin concentration
Time frame: Baseline (0 hours), 2 hours, and 6 hours after beverage intake
Change from baseline in plasma triglyceride concentration
Time frame: Baseline (0 hours), 2 hours, and 6 hours after beverage intake
Change from baseline in plasma total cholesterol concentration
Time frame: Baseline (0 hours), 2 hours, and 6 hours after beverage intake
Change from baseline in plasma HDL cholesterol concentration
Time frame: Baseline (0 hours), 2 hours, and 6 hours after beverage intake
Change from baseline in plasma LDL cholesterol concentration
Time frame: Baseline (0 hours), 2 hours, and 6 hours after beverage intake
Change from baseline in plasma interleukin-6 (IL-6) concentration
Time frame: Baseline (0 hours), 2 hours, and 6 hours after beverage intake
Change from baseline in plasma tumor necrosis factor alpha (TNF-α) concentration
Time frame: Baseline (0 hours), 2 hours, and 6 hours after beverage intake
Change from baseline in plasma interleukin-1 beta (IL-1β) concentration
Time frame: Baseline (0 hours), 2 hours, and 6 hours after beverage intake
Change from baseline in plasma monocyte chemoattractant protein-1 (MCP-1/CCL2) concentration
Time frame: Baseline (0 hours), 2 hours, and 6 hours after beverage intake
Transendothelial electrical resistance (TEER) in an in vitro human blood-brain barrier model after exposure to postprandial extracellular vesicles
Time frame: EVs isolated at baseline (0 hours) and 2 hours after beverage intake; TEER assessed within 72 hours after EV isolation
Claudin-5 (CLDN5) protein expression in an in vitro human blood-brain barrier model after exposure to postprandial extracellular vesicles
Time frame: EVs isolated at baseline (0 hours) and 2 hours after beverage intake; protein expression assessed within 72 hours after EV isolation
Occludin (OCLN) protein expression in an in vitro human blood-brain barrier model after exposure to postprandial extracellular vesicles
Time frame: EVs isolated at baseline (0 hours) and 2 hours after beverage intake; protein expression assessed within 72 hours after EV isolation
Interleukin-6 (IL-6) concentration in microglial culture supernatant after exposure to postprandial extracellular vesicles
Time frame: EVs isolated at baseline (0 hours) and 2 hours after beverage intake; cytokines assessed within 72 hours after EV isolation
Tumor necrosis factor alpha (TNF-α) concentration in microglial culture supernatant after exposure to postprandial extracellular vesicles
Time frame: EVs isolated at baseline (0 hours) and 2 hours after beverage intake; cytokines assessed within 72 hours after EV isolation
IL1B mRNA expression in microglia after exposure to postprandial extracellular vesicles
Time frame: EVs isolated at baseline (0 hours) and 2 hours after beverage intake; gene expression assessed within 72 hours after EV isolation
Endothelial VCAM-1 protein expression after exposure to postprandial extracellular vesicles
Time frame: EVs isolated at baseline (0 hours) and 2 hours after beverage intake; assays conducted within 48 hours after EV isolation
Polyphenolic content of extracellular vesicles after wine intake
Time frame: Baseline (0 hours), postprandial peak (2 hours after beverage intake), and post-peak (6 hours after beverage intake).
Spearman correlation between EV cargo score and change from baseline in plasma glucose concentration
Time frame: Baseline (0 hours), 2 hours, and 6 hours after beverage intake (plasma glucose); EVs isolated at baseline (0 hours) and 2 hours after beverage intake
Endothelial ICAM-1 protein expression after exposure to postprandial extracellular vesicles
Time frame: EVs isolated at baseline (0 hours) and 2 hours after beverage intake; assays conducted within 48 hours after EV isolation
Nitric oxide (NO) production in endothelial cell culture supernatant after exposure to postprandial extracellular vesicles
Time frame: EVs isolated at baseline (0 hours) and 2 hours after beverage intake; assays conducted within 48 hours after EV isolation
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 23 Jan 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing White Wine, Red Wine and Water in people with Atherosclerosis Cardiovascular Disease and Obesity, 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 7 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 23 Jan 2026. 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. Some participants in this study may receive a placebo. 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?
Contact Sergio Montserrat-de la Paz, Full Professor (+34 605383541, delapaz@us.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of circulating extracellular vesicles (time frame: Baseline (0 hours), postprandial peak (2 hours after beverage intake), and post-peak (6 hours after beverage intake).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2026.