Exploration of Potential Biomarkers of Polyphenol Intake From Artichoke By-product Supplements (ARTI-UP ADME)

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Adult Participants; ADME; Polyphenols Absorption Profile; Polyphenolic Compounds and Metabolism
• Intervention / Treatment: Dietary supplement: Single intake of a supplement derived from artichoke by-products

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Iziar A Ludwig, PhD; Phone Number: 806652 +34 948425600; Email: uinclint@unav.es
• Study Contact Backup: Name: Idoia Ibero, PhD; Phone Number: 806699 +34 948 425 600; Email: iibero@unav.es

Study Locations

• Spain
  • Navarre
    • Pamplona, Navarre, Spain, 31008
      • Recruiting
      • Universidad de Navarra
      • Contact: Idoia Ibero, PhD; Phone Number: 806699 +34 948 425 600; Email: iibero@unav.es
      • Contact: Iziar A Ludwig, PhD; Phone Number: 806652 +34 948 425600; Email: iludwig@unav.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Dietary Intervention: Single intake of a supplement derived from artichoke by-products; 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.

Dietary supplement: Single intake of a supplement derived from artichoke by-products; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	Baseline, 0-4 hours, 4-7 hours, 7-12 hours, 12-24 hours, and 24-48 hours

Collaborators and Investigators

• Sponsor: Iziar Amaia Ludwig Sanz Orrio
• Collaborators: Ministerio de Ciencia e Innovación, Spain
• Investigators: Principal Investigator: Iziar A Ludwig Sanz-Orrio, University of Navarra

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2026
• Primary Completion (Estimated): June 25, 2026
• Study Completion (Estimated): June 25, 2026

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: May 22, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ARTI-UP ADME

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Anonymized individual data on the bioavailability and metabolism of HCAs will only be shared if noteworthy inter-individual variability is detected.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No