Pharmacokinetic Characterization of Tartaric Acid in Humans

NCT07394101 | Not Yet Recruiting

• 1 other identifier: HCB/2025/1296
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Tartaric acid; Pharmacokinetics; Bioavailability; Food matrix effect; Wine; Healthy volunteers

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• 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

• Maximum cumulative urinary concentration

  0-24 hours, collected in fractions: 0-4, 4-8, 8-12, and 12-24 h post-ingestion

• Comparison of pharmacokinetic parameters by matrix

  grape, grape juice) to assess matrix- and dose-dependence. 0-24 hours post-ingestion

Study Arms (3)

Red Wine

EXPERIMENTAL

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

Grape fruits

EXPERIMENTAL

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

Grape juice

EXPERIMENTAL

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

Interventions

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.

Red Wine

Grape DIETARY_SUPPLEMENT

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

Grape fruits

Juice DIETARY_SUPPLEMENT

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

Grape juice

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion Clinic per a la Recerca Biomédica: lead

Study Sites (1)

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

Barcelona, Barcelona, 08036, Spain

Location

MeSH Terms

Interventions

Wine; whole grape extract

Intervention Hierarchy (Ancestors)

Alcoholic Beverages; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Fermented Beverages; Fermented Foods; Food and Beverages

Central Study Contacts

Anallely López Yerena, PI

CONTACT

932275400; nayelopezye@ub.edu

Rosa M. Lamuela-Raventós, Co-PI

CONTACT

Lamuela-Raventós; lamuela@ub.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking will be partial: participants will be blind to hypotheses but not to the intervention (due to the nature of the matrices).
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Researcher

Model Details: 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.

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 6, 2026
• Study Start: April 1, 2026
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)