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NCT Number: NCT07394101

Pharmacokinetic Characterization of Tartaric Acid in Humans

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.

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Key information

Conditions

Healthy Adult Participants Non-smoking, Healthy Adults Normal Weight Adults

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Internal Medicine, Hospital Clínic, Institut d'Investigació Biomèdica August Pi i Sunyer

Barcelona, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wine

Dietary Supplement

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.

Grape

Dietary Supplement

Portion of fresh grapes providing an equivalent dose of tartaric acid as the wine, consumed under the same controlled conditions.

Juice

Dietary Supplement

150 mL of grape juice standardized for tartaric acid content, ingested under identical conditions as the other arms.

Primary outcomes

  1. Oral bioavailability of tartaric acid

    Time frame: 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.

  2. 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

    Determination of the peak plasma concentration of tartaric acid in human plasma using liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS).

  3. 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

    Time required to reach the Cmax of tartaric acid in plasma.

  4. 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

    Total plasma exposure of tartaric acid determined by non-compartmental analysis using WinNonlin.

Secondary outcomes

  1. 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

    Time required to reduce plasma tartaric acid concentration by half, calculated using non-compartmental analysis.

  2. Maximum cumulative urinary concentration

    Time frame: 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.

  3. Comparison of pharmacokinetic parameters by matrix

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anallely López Yerena, PI

CONTACT

[email protected]

932275400 ext. 2907

Rosa M. Lamuela-Raventós, Co-PI

CONTACT

[email protected]

Lamuela-Raventós

Sponsors and collaborators

Lead sponsor

Fundacion Clinic per a la Recerca Biomédica

Other

Registry information

Official study title

Pharmacokinetic Characterization of Tartaric Acid in Humans: Effect of the Food Matrix (Wine, Grapes, and Juice) on Its Bioavailability

Acronym: TARBIO

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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