Pharmacokinetic Characterization of Tartaric Acid in Humans: Effect of the Food Matrix (Wine, Grapes, and Juice) on Its Bioavailability
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Oral bioavailability of tartaric acid
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Masking will be partial: participants will be blind to hypotheses but not to the intervention (due to the nature of the matrices).
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Wine (Dietary Supplement)
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.
干预措施: Grape (Dietary Supplement)
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.
干预措施: Juice (Dietary Supplement)
结局指标
主要结局
Oral bioavailability of tartaric acid
时间窗: 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.
Maximum plasma concentration (Cmax)
时间窗: 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).
Time to reach maximum plasma concentration (Tmax)
时间窗: 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.
Area under the plasma concentration-time curve (AUC)
时间窗: 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.
次要结局
- 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)
研究者
Anallely Lopez
Postdoctoral Researcher
Fundacion Clinic per a la Recerca Biomédica