Pharmacokinetic Characterization of Tartaric Acid in Humans
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-40
SponsorFundacion Clinic per a la Recerca Biomédica
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
This trial accepts healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Wine
Dietary supplement100 mL of red wine containing a standardized dose of tartaric acid, ingested after a 10-hour overnight fast with a standardized meal (2 slices of white bread). Consumption completed within 5 minutes, fluid intake controlled, compliance monitored.
Grape
Dietary supplementPortion of fresh grapes providing an equivalent dose of tartaric acid as the wine, consumed under the same controlled conditions.
Juice
Dietary supplement150 mL of grape juice standardized for tartaric acid content, ingested under identical conditions as the other arms.
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: Red WineExperimental treatment 1 intervention
Group B: Grape fruitsExperimental treatment 1 intervention
Group C: Grape juiceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Oral bioavailability of tartaric acid
Quantification of the oral bioavailability of tartaric acid after administration in different dietary matrices (wine, grape, grape juice) using dose-response studies.
Time frame
0-24 hours post-ingestion2
Maximum plasma concentration (Cmax)
Determination of the peak plasma concentration of tartaric acid in human plasma using liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS).
Time frame
0-24 hours, sampling at 0, 15, 30 min, 1, 2, 3, 4, 6, 8, and 24 h post-ingestion3
Time to reach maximum plasma concentration (Tmax)
Time required to reach the Cmax of tartaric acid in plasma.
Time frame
0-24 hours, sampling at 0, 15, 30 min, 1, 2, 3, 4, 6, 8, and 24 h post-ingestion4
Area under the plasma concentration-time curve (AUC)
Total plasma exposure of tartaric acid determined by non-compartmental analysis using WinNonlin.
Time frame
0-24 hours, sampling at 0, 15, 30 min, 1, 2, 3, 4, 6, 8, and 24 h post-ingestionSecondary outcomes
1
Plasma half-life (t1/2)
Time required to reduce plasma tartaric acid concentration by half, calculated using non-compartmental analysis.
Time frame
0-24 hours, sampling at 0, 15, 30 min, 1, 2, 3, 4, 6, 8, and 24 h post-ingestion2
Maximum cumulative urinary concentration
Maximum amount of tartaric acid excreted in urine, measured by LC-ESI-MS/MS.
Time frame
0-24 hours, collected in fractions: 0-4, 4-8, 8-12, and 12-24 h post-ingestion3
Comparison of pharmacokinetic parameters by matrix
Comparison of Cmax, Tmax, AUC, and t1/2 between dietary matrices (wine, grape, grape juice) to assess matrix- and dose-dependence.
Time frame
grape, grape juice) to assess matrix- and dose-dependence. 0-24 hours post-ingestionSponsors and contacts
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Source ClinicalTrials.gov
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