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

NCT07361887 | Recruiting DMC

• 1 other identifier: 2024-2934
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obesity; Metabolic Syndrome; Metabolic Disorders; Inflammation; Neurodegeneration; Neurodegenerative Disease; Alzheimer s Disease; Atherosclerosis Cardiovascular Disease

Keywords

blood-brain barrier; microglia; extracellular vesicles; lipidome; proteome; vascular disease

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  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

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

• Postprandial changes in extracellular vesicle lipidome

  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

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

• Change from baseline in plasma insulin concentration

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

• Change from baseline in plasma triglyceride concentration

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

Study Arms (3)

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).

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).

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).

Dietary Supplement: Water

Interventions

Red Wine DIETARY_SUPPLEMENT

Cabernet Sauvignon, 4 mL/kg body weight

Red Wine

Water DIETARY_SUPPLEMENT

Still water, 4 mL/kg body weight

Water (Control)

White Wine DIETARY_SUPPLEMENT

Chardonnay, 4 mL/kg body weight

White Wine

Eligibility Criteria

• Age: 35 Years - 36 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

Av. de Sánchez Pizjuán, s/n, 41009 Sevilla Facultad de Medicina . Universidad de Sevilla

Seville, Sevilla, 41009, Spain

RECRUITING

MeSH Terms

Conditions

Obesity; Metabolic Syndrome; Metabolic Diseases; Inflammation; Nerve Degeneration; Neurodegenerative Diseases; Vascular Diseases

Interventions

Water

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Pathologic Processes; Nervous System Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Central Study Contacts

Sergio Montserrat-de la Paz, Full Professor

CONTACT

+34 605383541; delapaz@us.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: January 23, 2026
• Study Start: November 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): March 31, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

ES (1)