Pharmacokinetic Characterization of Tartaric Acid in Humans (TARBIO)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Adult Participants; Non-smoking, Healthy Adults; Normal Weight Adults
• Intervention / Treatment: Dietary supplement: Wine; Dietary supplement: Grape; Dietary supplement: Juice

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anallely López Yerena, PI; Phone Number: 2907 932275400; Email: nayelopezye@ub.edu
• Study Contact Backup: Name: Rosa M. Lamuela-Raventós, Co-PI; Phone Number: Lamuela-Raventós; Email: lamuela@ub.edu

Study Locations

• Spain
  • Barcelona
    • Barcelona, Barcelona, Spain, 08036
      • Department of Internal Medicine, Hospital Clínic, Institut d'Investigació Biomèdica August Pi i Sunyer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Red Wine; Participants will consume 100 mL of red wine, providing a standardized dose of tartaric acid, after a 10-hour overnight fast. The wine will be ingested within 5 minutes, accompanied by a standardized meal (2 slices of white bread) to simulate real-life consumption conditions. Intake of other fluids will be controlled (water ad libitum except during the first hour), and compliance will be monitored through direct observation.	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.
Experimental: Grape fruits; Participants will consume a portion of fresh grapes containing an equivalent dose of tartaric acid to the wine, following the same controlled conditions: after a 10-hour overnight fast, ingested within 5 minutes with the standardized meal, with controlled fluid intake and direct compliance monitoring.	Dietary supplement: Grape; Portion of fresh grapes providing an equivalent dose of tartaric acid as the wine, consumed under the same controlled conditions.
Experimental: Grape juice; Participants will consume 150 mL of grape juice standardized for tartaric acid content, under identical conditions: after a 10-hour overnight fast, ingested within 5 minutes with the standardized meal, with controlled fluid intake and compliance monitoring.	Dietary supplement: Juice; 150 mL of grape juice standardized for tartaric acid content, ingested under identical conditions as the other arms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	0-24 hours post-ingestion
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).	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 required to reach the Cmax of tartaric acid in plasma.	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)	Total plasma exposure of tartaric acid determined by non-compartmental analysis using WinNonlin.	0-24 hours, sampling at 0, 15, 30 min, 1, 2, 3, 4, 6, 8, and 24 h post-ingestion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma half-life (t1/2)	Time required to reduce plasma tartaric acid concentration by half, calculated using non-compartmental analysis.	0-24 hours, sampling at 0, 15, 30 min, 1, 2, 3, 4, 6, 8, and 24 h post-ingestion
Maximum cumulative urinary concentration	Maximum amount of tartaric acid excreted in urine, measured by LC-ESI-MS/MS.	0-24 hours, collected in fractions: 0-4, 4-8, 8-12, and 12-24 h post-ingestion
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.	grape, grape juice) to assess matrix- and dose-dependence. 0-24 hours post-ingestion

Collaborators and Investigators

• Sponsor: Fundacion Clinic per a la Recerca Biomédica

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Healthy volunteers; Pharmacokinetics; Bioavailability; Wine; Tartaric acid; Food matrix effect
• Additional Relevant MeSH Terms: Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Beverages; Fermented Foods; Alcoholic Beverages; Fermented Beverages; whole grape extract; Wine
• Other Study ID Numbers: HCB/2025/1296

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No