Exploration of Potential Biomarkers of Polyphenol Intake From Artichoke By-product Supplements (NCT07615673) | Clinical Trial Compass
RecruitingNot Applicable
Exploration of Potential Biomarkers of Polyphenol Intake From Artichoke By-product Supplements
Spain16 participantsStarted 2026-05-26
Plain-language 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 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* 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 demon…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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 the qualitative identification of HCAs and their metabolites of dehydrated artichokes by-product in plasma between baseline and 48 h post consumption
Change in the plasmatic concentration of HCAs (nanomol/L) and their metabolites of dehydrated artichoke by-prodcuts between baseline and 48 h post consumption