Healthy Adult ParticipantsTARBIONCT07394101
Pharmacokinetic Characterization of Tartaric Acid in Humans
A study testing Wine, Grape and Juice in people with Healthy Adult Participants and Non-smoking, Healthy Adults, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants, Non-smoking, Healthy Adults, Normal Weight Adults
- What is being tested?
- Wine, Grape and Juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2026to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Department of Internal Medicine, Hospital Clínic, Institut d'Investigació Biomèdica August Pi i Sunyer
Barcelona, Barcelona, 08036
About this study
Official title: 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:
Read more
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.
Read the 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.
- Being tested
- Wine, Grape, Juice
- Keywords
- Tartaric acid, Pharmacokinetics, Bioavailability, Food matrix effect, Wine, Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WineDietary 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.
GrapeDietary supplement
Portion of fresh grapes providing an equivalent dose of tartaric acid as the wine, consumed under the same controlled conditions.
JuiceDietary supplement
150 mL of grape juice standardized for tartaric acid content, ingested under identical conditions as the other arms.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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)
Time required to reduce plasma tartaric acid concentration by half, calculated using non-compartmental analysis.
Measured: 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.
Measured: 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.
Measured: grape, grape juice) to assess matrix- and dose-dependence. 0-24 hours post-ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study startApr 2026 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anallely Lopez, Fundacion Clinic per a la Recerca Biomédica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394101
- Sponsor's protocol ID
- HCB/2025/1296
- Acronym
- TARBIO
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Characterization of Tartaric Acid in Humans: Effect of the Food Matrix (Wine, Grapes, and Juice) on Its Bioavailability
- ClinicalTrials.gov ID
- NCT07394101
- Acronym / sponsor ID
- TARBIO / HCB/2025/1296
- Keywords
- Tartaric acid, Pharmacokinetics, Bioavailability, Food matrix effect, Wine, Healthy volunteers
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Red Wine | Experimental | Dietary Supplement: WineParticipants 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. |
| Grape fruits | Experimental | Dietary Supplement: GrapeParticipants 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. |
| Grape juice | Experimental | Dietary Supplement: JuiceParticipants 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wine100 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. | Dietary supplement | Red Wine |
| GrapePortion of fresh grapes providing an equivalent dose of tartaric acid as the wine, consumed under the same controlled conditions. | Dietary supplement | Grape fruits |
| Juice150 mL of grape juice standardized for tartaric acid content, ingested under identical conditions as the other arms. | Dietary supplement | Grape juice |
Primary outcome
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.
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).
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.
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.
3 secondary outcomes
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
Maximum cumulative urinary concentration
Time frame: 0-24 hours, collected in fractions: 0-4, 4-8, 8-12, and 12-24 h post-ingestion
Comparison of pharmacokinetic parameters by matrix
Time frame: grape, grape juice) to assess matrix- and dose-dependence. 0-24 hours post-ingestion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wine, Grape and Juice in people with Healthy Adult Participants and Non-smoking, Healthy Adults, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anallely López Yerena, PI (932275400 ext. 2907, nayelopezye@ub.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral bioavailability of tartaric acid (time frame: 0-24 hours post-ingestion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.