Pharmacokinetic Characterization of Tartaric Acid in Humans
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Wine, Grape, Juice.
- Who it may be relevant to
- Registry conditions: Healthy Adult Participants, Non-smoking, Healthy Adults, Normal Weight Adults. Basic parameters: 20 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pharmacokinetic Characterization of Tartaric Acid in Humans: Effect of the Food Matrix (Wine, Grapes, and Juice) on Its Bioavailability
Overview
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 supplement Wine
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 supplement Grape
Portion of fresh grapes providing an equivalent dose of tartaric acid as the wine, consumed under the same controlled conditions. - Dietary supplement Juice
150 mL of grape juice standardized for tartaric acid content, ingested under identical conditions as the other arms.
Primary outcome measures
- Oral bioavailability of tartaric acid [Time frame: 0-24 hours post-ingestion]
- Maximum plasma concentration (Cmax) [Time frame: 0-24 hours, sampling at 0, 15, 30 min, 1, 2, 3, 4, 6, 8, and 24 h post-ingestion]
- Time to reach maximum plasma concentration (Tmax) [Time frame: 0-24 hours, sampling at 0, 15, 30 min, 1, 2, 3, 4, 6, 8, and 24 h post-ingestion]
- Area under the plasma concentration-time curve (AUC) [Time frame: 0-24 hours, sampling at 0, 15, 30 min, 1, 2, 3, 4, 6, 8, and 24 h post-ingestion]
Secondary outcome measures (3)
- Plasma half-life (t1/2) [Time frame: 0-24 hours, sampling at 0, 15, 30 min, 1, 2, 3, 4, 6, 8, and 24 h post-ingestion]
- Maximum cumulative urinary concentration [Time frame: 0-24 hours, collected in fractions: 0-4, 4-8, 8-12, and 12-24 h post-ingestion]
- Comparison of pharmacokinetic parameters by matrix [Time frame: grape, grape juice) to assess matrix- and dose-dependence. 0-24 hours post-ingestion]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Spain · 1 center
- Department of Internal Medicine, Hospital Clínic, Institut d'Investigació Biomèdica August — Barcelona
Identifiers
NCT: NCT07394101 · HCB/2025/1296