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NCT Number: NCT07615673

Exploration of Potential Biomarkers of Polyphenol Intake From Artichoke By-product Supplements

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.

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Key information

Conditions

Healthy Adult Participants ADME Polyphenolic Compounds and Metabolism Polyphenols Absorption Profile

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 demonstrate difficulty swallowing capsules, tablets, pills, or similar.

Treatment and study plan

Single intake of a supplement derived from artichoke by-products

Dietary 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.

Primary outcomes

  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

    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).

  2. 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).

  3. 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).

  4. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Idoia Ibero, PhD

CONTACT

[email protected]

+34 948 425 600 ext. 806699

Iziar A Ludwig, PhD

CONTACT

[email protected]

+34 948425600 ext. 806652

Sponsors and collaborators

Lead sponsor

Iziar Amaia Ludwig Sanz Orrio

Other

Collaborators

  • Ministerio de Ciencia e Innovación, Spain

Registry information

Official study title

Exploration of Potential Biomarkers of Polyphenol Intake From a Supplement Derived From Artichoke By-products Rich in Hydroxycinnamic Acids

Acronym: ARTI-UP ADME

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 29, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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