About this trial
The goal of this clinical trial is to characterize the pharmacokinetics (absorption, distribution, metabolism, and excretion; ADME) and oral bioavailability of tartaric acid in humans after its administration through different food matrices (red wine, fresh grapes, and grape juice). The study aims to determine whether the pharmacokinetic behavior of tartaric acid is matrix-dependent and dose-dependent in healthy adult volunteers.
The main questions it aims to answer are:
Does the food matrix (wine, grapes, or grape juice) influence the oral bioavailability of tartaric acid?
Are there differences in key pharmacokinetic parameters of tartaric acid, including maximum plasma concentration (Cmax), time to reach maximum concentration (Tmax), total exposure (AUC), half-life (t1/2), and urinary excretion, depending on the matrix of intake?
Researchers will compare the pharmacokinetic profiles of tartaric acid after consumption in red wine, grapes, and grape juice to evaluate differences in absorption, systemic exposure, and elimination attributable to the source of intake.
Participants will:
Follow a polyphenol-restricted diet prior to the study, including avoidance of grapes, wine, and related products.
Consume a single standardized dose of tartaric acid administered as red wine, fresh grapes, or grape juice after an overnight fast.
Provide blood samples at multiple time points over a 24-hour period to determine plasma tartaric acid concentrations.
Collect urine samples over 24 hours for assessment of tartaric acid excretion.
Consume standardized low-polyphenol meals under controlled conditions during the study day.
Eligibility criteria
Qualifiers
Healthy non-smoking adults aged 20-40 years.
Body mass index (BMI) between 23 and 27 kg/m².
No history of cardiovascular, hepatic, or renal disease.
No adherence to any special diet for at least 4 weeks prior to the study.
Disqualifiers
Current smokers or recent ex-smokers.
History of cardiovascular, hepatic, or renal disorders.
Current adherence to any special diet or nutritional supplementation that could affect study outcomes.
Any condition or medication that could interfere with absorption, metabolism, or excretion of tartaric acid.
Trial design
Treatments tested in this trial
- Wine
- Grape
- Juice