Deciphering the Effect of Moderate Wine Consumption on Healthy Aging Through Postprandial Extracellular Vesicles.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-36
SponsorUniversity of Seville

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • White Wine

    Dietary supplement

    Chardonnay, 4 mL/kg body weight

  • Red Wine

    Dietary supplement

    Cabernet Sauvignon, 4 mL/kg body weight

  • Water

    Dietary supplement

    Still water, 4 mL/kg body weight

Treatment groups

8 Participants
are divided into 3 treatment groups
Group A: Red WineExperimental treatment 1 intervention
Group B: White WineExperimental treatment 1 intervention
Group C: Water (Control)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
Baseline (0 hours), postprandial peak (2 hours after beverage intake), and post-peak (6 hours after beverage intake).
2

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).

Time frame
Baseline (0 hours), postprandial peak (2 hours after beverage intake), and post-peak (6 hours after beverage intake).

Secondary outcomes

1

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.

Time frame
Baseline (0 hours), postprandial peak (2 hours after beverage intake), and post-peak (6 hours after beverage intake).
2

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.

Time frame
Baseline (0 hours), postprandial peak (2 hours after beverage intake), and post-peak (6 hours after beverage intake).
3

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

Time frame
Baseline (0 hours), 2 hours, and 6 hours after beverage intake
4

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

Time frame
Baseline (0 hours), 2 hours, and 6 hours after beverage intake

Other outcomes

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