Healthy Adult ParticipantsARTI-UP ADMENCT07615673
Exploration of Potential Biomarkers of Polyphenol Intake From Artichoke By-product Supplements
A study testing Single intake of a supplement derived from artichoke by-products in people with Healthy Adult Participants and ADME, run by Iziar Amaia Ludwig Sanz Orrio at 1 site in Spain.
Trial summary
The bioavailability study analyzes the absorption, distribution, metabolism, and excretion (ADME) processes of the polyphenols under study (HCAs). To achieve the planned objectives, blood and urine samples will be collected before and at different time intervals following the intake of the study supplement, which will… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants, ADME, Polyphenols Absorption Profile
- What is being tested?
- Single intake of a supplement derived from artichoke by-products
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSpain
- Study dates
- 26 May 2026to 25 Jun 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women between 18 and 75 years of age.
- Normal-weight volunteers (BMI of 18.5-24.9 kg/m²).
- Subjects must be able to understand and willing to sign the informed consent form, and must comply with all study procedures and requirements.
Who cannot join
- Presence of chronic gastrointestinal pathology.
- Lactating or pregnant women, or those planning to become pregnant.
- Individuals who have taken antibiotics within the 3 months prior to the study.
- Individuals currently taking supplements (plant-derived, fiber, or probiotics) unless they are willing to discontinue use during the 4-day study intervention and ensure a minimum washout period of 14 days prior to baseline measurements.
- Individuals with an alcohol intake > 80 g/day.
- Presence of allergy or intolerance to artichoke.
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- Individuals undergoing treatment with anticoagulants, immunosuppressants, or cytotoxic agents.
- Presence of renal or hepatic failure.
- Presence of immunodeficiency or being HIV positive.
- Subjects with any type of cancer, those undergoing cancer treatment, or those for whom at least 5 years have not passed since remission.
- Presence of weight loss greater than 5% in the 6 months prior to the trial.
- Lack of time or geographical availability to attend the study visits.
- Failure to sign the informed consent form.
- Difficulty in undergoing blood extraction/collection.
- Having donated blood within 14 days prior to the baseline visit.
- Individuals who demonstrate difficulty swallowing capsules, tablets, pills, or similar.
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, 1 recruiting
- Recruiting
Universidad de Navarra
Pamplona, Navarre, 31008
Idoia Ibero, PhD, +34 948 425 600 ext. 806699, iibero@unav.es
Iziar A Ludwig, PhD, +34 948 425600 ext. 806652, iludwig@unav.es
About this study
Official title: Exploration of Potential Biomarkers of Polyphenol Intake From a Supplement Derived From Artichoke By-products Rich in Hydroxycinnamic Acids
The bioavailability study analyzes the absorption, distribution, metabolism, and excretion (ADME) processes of the polyphenols under study (HCAs). To achieve the planned objectives, blood and urine samples will be collected before and at different time intervals following the intake of the study supplement, which will consist of capsules made from dehydrated artichoke by-products rich in HCAs.
To determine the bioavailability of the active compounds, volunteers will be asked to follow a diet low in polyphenols/plant-based foods for 48 hours prior to the supplement intake and up to 48 hours after product consumption. Blood and urine samples will be collected before intake and during the following 48 hours. Subsequently, the samples will be analyzed using high-performance liquid chromatography coupled with mass spectrometry (HPLC-MS) to identify and quantify the bioactive compounds of interest and their metabolites. The results of the ADME trial will allow for the identification of plasma and urinary metabolites, the characterization of intake markers, and the determination of inter-individual differences in metabolic profiles.
- Conditions
- Healthy Adult Participants, ADME, Polyphenols Absorption Profile, Polyphenolic Compounds and Metabolism
- Being tested
- Single intake of a supplement derived from artichoke by-products
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single intake of a supplement derived from artichoke by-productsDietary supplement
A single dose of 6 capsules of dehydrated artichoke by-product (containing 197.4 mg HCAs) consumed within 15 minutes accompanied by 250 ml of water.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Intervention: Single intake of a supplement derived from artichoke by-products | Experimental | Subjects will be asked to follow a low-(poly)phenol diet during the preceding two days and during the 48 h of the dietary intervention. On the day of the study, each volunteer will ingest the content of 6 capsules containing the amount of by-product artichoke powder able to deliver 197.4 mg of HCAs after fasting overnight. Blood samples at baseline (0 h) and different post-intake times (1, 2, 4, 7, 24, and 48 h) will be collected. Urine samples will be collected in the following time intervals: 24 h pre-intake, 0-4, 4-8, 8-12, 12-24, and 24-48 h. Receives: Dietary Supplement: Single intake of a supplement derived from artichoke by-products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the qualitative identification of HCAs and their metabolites of dehydrated artichoke by-product in urine between baseline and 48 h post-consumption
Change in HCAs and their metabolites in urine between baseline and 48h post consumption will be measured by identifying qualitatively metabolites from dehydrated artichokes by-products at different time points using chromatography coupled with mass spectrometry analytical techniques (UPLC-MS).
Measured: Baseline, 0-4 hours, 4-7 hours, 7-12 hours, 12-24 hours, and 24-48 hours
Change in the qualitative identification of HCAs and their metabolites of dehydrated artichokes by-product in plasma between baseline and 48 h post consumption
Change in HCAs and their metabolites in plasma between baseline and 48 h post consumption will be measured by identifying qualitatively metabolites from dehydrated artichoke by-product at different time points using chromatography coupled with mass spectrometry analytical techniques (UPLC-MS).
Measured: Baseline, 1 hours, 2 hour, 4 hours, 7 hours, 24 hours, and 48 hours
Change in the plasmatic concentration of HCAs (nanomol/L) and their metabolites of dehydrated artichoke by-prodcuts between baseline and 48 h post consumption
Bioavailability and metabolism from artichoke by-product polyphenols will be studied by evaluating changes in concentration of HCA and their metabolites (nanomol/L) in plasma samples at different time points using chromatography coupled with mass spectrometry analytical techniques (UPLC-MS).
Measured: Baseline, 1 hours, 2 hour, 4 hours, 7 hours, 24 hours, and 48 hours
Change in the concentration of artichoke by-product HCAs in urine (nanomol/L) and their metabolites between baseline and 24 h post consumption
Metabolism and excretion from artichoke by-product polyphenols will be studied by evaluating changes in HCAs and their metabolite concentration (nanomol/L) in urine samples at different time points using chromatography coupled with mass spectrometry analytical techniques (UPLC-MS).
Measured: Baseline, 0-4 hours, 4-7 hours, 7-12 hours, 12-24 hours, and 24-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start26 May 2026
- Primary completion25 Jun 2026 (estimated)
- Study completion25 Jun 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iziar Amaia Ludwig Sanz Orrio
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain
- Responsible party
- Sponsor-investigator, Iziar Amaia Ludwig Sanz Orrio, Clinica Universidad de Navarra, Universidad de Navarra
- Investigators
- Iziar A Ludwig Sanz-Orrio, Principal investigator, University of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615673
- Sponsor's protocol ID
- ARTI-UP ADME
- Acronym
- ARTI-UP ADME
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 3 Jun 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 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Potential Biomarkers of Polyphenol Intake From a Supplement Derived From Artichoke By-products Rich in Hydroxycinnamic Acids
- ClinicalTrials.gov ID
- NCT07615673
- Acronym / sponsor ID
- ARTI-UP ADME / ARTI-UP ADME
- Conditions
- Healthy Adult Participants, ADME, Polyphenols Absorption Profile, Polyphenolic Compounds and Metabolism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Iziar Amaia Ludwig Sanz OrrioUniversity, hospital or other
- Collaborators
- Ministerio de Ciencia e Innovación, Spain
- Study start
- 26 May 2026 (actual)
- Primary completion
- 25 Jun 2026 (estimated)
- Study completion
- 25 Jun 2026 (estimated)
- First posted
- 29 May 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 bioavailability study analyzes the absorption, distribution, metabolism, and excretion (ADME) processes of the polyphenols under study (HCAs). To achieve the planned objectives, blood and urine samples will be collected before and at different time intervals following the intake of the study supplement, which will consist of capsules made from dehydrated artichoke by-products rich in HCAs.
To determine the bioavailability of the active compounds, volunteers will be asked to follow a diet low in polyphenols/plant-based foods for 48 hours prior to the supplement intake and up to 48 hours after product consumption. Blood and urine samples will be collected before intake and during the following 48 hours. Subsequently, the samples will be analyzed using high-performance liquid chromatography coupled with mass spectrometry (HPLC-MS) to identify and quantify the bioactive compounds of interest and their metabolites. The results of the ADME trial will allow for the identification of plasma and urinary metabolites, the characterization of intake markers, and the determination of inter-individual differences in metabolic profiles.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary Intervention: Single intake of a supplement derived from artichoke by-products | Experimental | Dietary Supplement: Single intake of a supplement derived from artichoke by-productsSubjects will be asked to follow a low-(poly)phenol diet during the preceding two days and during the 48 h of the dietary intervention. On the day of the study, each volunteer will ingest the content of 6 capsules containing the amount of by-product artichoke powder able to deliver 197.4 mg of HCAs after fasting overnight. Blood samples at baseline (0 h) and different post-intake times (1, 2, 4, 7, 24, and 48 h) will be collected. Urine samples will be collected in the following time intervals: 24 h pre-intake, 0-4, 4-8, 8-12, 12-24, and 24-48 h. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women between 18 and 75 years of age.
- Normal-weight volunteers (BMI of 18.5-24.9 kg/m²).
- Subjects must be able to understand and willing to sign the informed consent form, and must comply with all study procedures and requirements.
Key exclusion criteria (16 listed)
- Presence of chronic gastrointestinal pathology.
- Lactating or pregnant women, or those planning to become pregnant.
- Individuals who have taken antibiotics within the 3 months prior to the study.
- Individuals currently taking supplements (plant-derived, fiber, or probiotics) unless they are willing to discontinue use during the 4-day study intervention and ensure a minimum washout period of 14 days prior to baseline measurements.
- Individuals with an alcohol intake > 80 g/day.
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 |
|---|---|---|
| Single intake of a supplement derived from artichoke by-productsA single dose of 6 capsules of dehydrated artichoke by-product (containing 197.4 mg HCAs) consumed within 15 minutes accompanied by 250 ml of water. | Dietary supplement | Dietary Intervention: Single intake of a supplement derived from artichoke by-products |
Primary outcome
Change in the qualitative identification of HCAs and their metabolites of dehydrated artichoke by-product in urine between baseline and 48 h post-consumption
Time frame: Baseline, 0-4 hours, 4-7 hours, 7-12 hours, 12-24 hours, and 24-48 hours
Change in HCAs and their metabolites in urine between baseline and 48h post consumption will be measured by identifying qualitatively metabolites from dehydrated artichokes by-products at different time points using chromatography coupled with mass spectrometry analytical techniques (UPLC-MS).
Change in the qualitative identification of HCAs and their metabolites of dehydrated artichokes by-product in plasma between baseline and 48 h post consumption
Time frame: Baseline, 1 hours, 2 hour, 4 hours, 7 hours, 24 hours, and 48 hours
Change in HCAs and their metabolites in plasma between baseline and 48 h post consumption will be measured by identifying qualitatively metabolites from dehydrated artichoke by-product at different time points using chromatography coupled with mass spectrometry analytical techniques (UPLC-MS).
Change in the plasmatic concentration of HCAs (nanomol/L) and their metabolites of dehydrated artichoke by-prodcuts between baseline and 48 h post consumption
Time frame: Baseline, 1 hours, 2 hour, 4 hours, 7 hours, 24 hours, and 48 hours
Bioavailability and metabolism from artichoke by-product polyphenols will be studied by evaluating changes in concentration of HCA and their metabolites (nanomol/L) in plasma samples at different time points using chromatography coupled with mass spectrometry analytical techniques (UPLC-MS).
Change in the concentration of artichoke by-product HCAs in urine (nanomol/L) and their metabolites between baseline and 24 h post consumption
Time frame: Baseline, 0-4 hours, 4-7 hours, 7-12 hours, 12-24 hours, and 24-48 hours
Metabolism and excretion from artichoke by-product polyphenols will be studied by evaluating changes in HCAs and their metabolite concentration (nanomol/L) in urine samples at different time points using chromatography coupled with mass spectrometry analytical techniques (UPLC-MS).
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 3 Jun 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.
Iziar A Ludwig Sanz-Orrio principal investigator
University of Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single intake of a supplement derived from artichoke by-products in people with Healthy Adult Participants and ADME, run by Iziar Amaia Ludwig Sanz Orrio 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 3 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 3 Jun 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 Iziar A Ludwig, PhD (+34 948425600 ext. 806652, uinclint@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the qualitative identification of HCAs and their metabolites of dehydrated artichoke by-product in urine between baseline and 48 h post-consumption (time frame: Baseline, 0-4 hours, 4-7 hours, 7-12 hours, 12-24 hours, and 24-48 hours). 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 3 Jun 2026.