Pharmacokinetic Characterization of Tartaric Acid in Humans

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка 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.
• Пищевая добавка Grape
  Portion of fresh grapes providing an equivalent dose of tartaric acid as the wine, consumed under the same controlled conditions.
• Пищевая добавка Juice
  150 mL of grape juice standardized for tartaric acid content, ingested under identical conditions as the other arms.

Первичные конечные точки

• Oral bioavailability of tartaric acid [Срок оценки: 0-24 hours post-ingestion]
• Maximum plasma concentration (Cmax) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 0-24 hours, sampling at 0, 15, 30 min, 1, 2, 3, 4, 6, 8, and 24 h post-ingestion]

Вторичные конечные точки (3)

• Plasma half-life (t1/2) [Срок оценки: 0-24 hours, sampling at 0, 15, 30 min, 1, 2, 3, 4, 6, 8, and 24 h post-ingestion]
• Maximum cumulative urinary concentration [Срок оценки: 0-24 hours, collected in fractions: 0-4, 4-8, 8-12, and 12-24 h post-ingestion]
• Comparison of pharmacokinetic parameters by matrix [Срок оценки: grape, grape juice) to assess matrix- and dose-dependence. 0-24 hours post-ingestion]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Испания · 1 центр

• Department of Internal Medicine, Hospital Clínic, Institut d'Investigació Biomèdica August — Barcelona

Идентификаторы

NCT: NCT07394101 · HCB/2025/1296

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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