Healthy Adult Participants, Non-smoking, Healthy Adults, Normal Weight Adults
Conditions
Keywords
Tartaric acid, Pharmacokinetics, Bioavailability, Food matrix effect, Wine, Healthy volunteers
Brief summary
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.
Detailed description
This study will characterize the pharmacokinetics (absorption, distribution, metabolism, and excretion) and oral bioavailability of tartaric acid (TA) in humans after consumption in different food matrices: red wine, fresh grapes, and grape juice. Although moderate wine consumption has been associated with cardiometabolic benefits, the human pharmacokinetics of TA-the main organic acid in grapes and wine-remain largely uncharacterized. Existing data from animal studies do not account for the influence of the food matrix on absorption or systemic exposure. TA has been proposed as an objective biomarker of wine intake, and its dietary presence may contribute to observed cardiovascular and anti-inflammatory effects. Bioavailability of bioactive compounds is strongly matrix-dependent, and interactions within complex foods can enhance or limit absorption. This study provides the first direct evaluation of whether TA pharmacokinetics differ depending on the food matrix. Using a randomized, parallel-group design, participants will receive a standardized dose of TA in one of the three matrices, with plasma and urine samples analyzed by advanced LC-MS/MS methods. Results will establish reference pharmacokinetic parameters, clarify the effect of the food matrix on TA bioavailability, and support development of functional grape-derived products, while improving interpretation of epidemiological evidence linking TA to cardiometabolic health.
Interventions
DIETARY_SUPPLEMENTWine
100 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.
DIETARY_SUPPLEMENTGrape
Portion of fresh grapes providing an equivalent dose of tartaric acid as the wine, consumed under the same controlled conditions.
DIETARY_SUPPLEMENTJuice
150 mL of grape juice standardized for tartaric acid content, ingested under identical conditions as the other arms.
Sponsors
Fundacion Clinic per a la Recerca Biomédica
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
Masking will be partial: participants will be blind to hypotheses but not to the intervention (due to the nature of the matrices).
Intervention model description
This is a randomized, partially blinded, interventional study designed to evaluate the effects of different polyphenol-containing matrices on healthy adults. Thirty healthy non-smoking participants (aged 20-40 years, BMI 23-27 kg/m²), without a history of cardiovascular, hepatic, or renal disease, and not following any special diet for at least 4 weeks prior to the study, will be recruited. Participants will be randomly assigned to one of three intervention groups (wine, grape, or juice) using a block randomization system stratified by sex to ensure a 1:1 balance across groups. The study will be partially blinded: participants will be unaware of the study hypothesis, but not the intervention, due to the nature of the matrices.
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* 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. * Willing and able to provide written informed consent.
Exclusion criteria
* 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. * Participation in another clinical trial within the past 3 months. * Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oral bioavailability of tartaric acid | 0-24 hours post-ingestion | Quantification of the oral bioavailability of tartaric acid after administration in different dietary matrices (wine, grape, grape juice) using dose-response studies. |
| Maximum plasma concentration (Cmax) | 0-24 hours, sampling at 0, 15, 30 min, 1, 2, 3, 4, 6, 8, and 24 h post-ingestion | Determination of the peak plasma concentration of tartaric acid in human plasma using liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS). |
| Time to reach maximum plasma concentration (Tmax) | 0-24 hours, sampling at 0, 15, 30 min, 1, 2, 3, 4, 6, 8, and 24 h post-ingestion | Time required to reach the Cmax of tartaric acid in plasma. |
| Area under the plasma concentration-time curve (AUC) | 0-24 hours, sampling at 0, 15, 30 min, 1, 2, 3, 4, 6, 8, and 24 h post-ingestion | Total plasma exposure of tartaric acid determined by non-compartmental analysis using WinNonlin. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma half-life (t1/2) | 0-24 hours, sampling at 0, 15, 30 min, 1, 2, 3, 4, 6, 8, and 24 h post-ingestion | Time required to reduce plasma tartaric acid concentration by half, calculated using non-compartmental analysis. |
| Maximum cumulative urinary concentration | 0-24 hours, collected in fractions: 0-4, 4-8, 8-12, and 12-24 h post-ingestion | Maximum amount of tartaric acid excreted in urine, measured by LC-ESI-MS/MS. |
| Comparison of pharmacokinetic parameters by matrix | grape, grape juice) to assess matrix- and dose-dependence. 0-24 hours post-ingestion | Comparison of Cmax, Tmax, AUC, and t1/2 between dietary matrices (wine, grape, grape juice) to assess matrix- and dose-dependence. |
Countries
Spain
Contacts
CONTACTAnallely López Yerena, PI
CONTACTRosa M. Lamuela-Raventós, Co-PI
Outcome results
None listed