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

NCT07615673 | Recruiting

• 1 other identifier: ARTI-UP ADME
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Adult Participants; ADME; Polyphenols Absorption Profile; Polyphenolic Compounds and Metabolism

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

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.

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

Interventions

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.

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Iziar Amaia Ludwig Sanz Orrio: lead
• Ministerio de Ciencia e Innovación, Spain: collaborator

Study Sites (1)

Universidad de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Study Officials

• Iziar A Ludwig Sanz-Orrio

  University of Navarra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iziar A Ludwig, PhD

CONTACT

+34 948425600; uinclint@unav.es

Idoia Ibero, PhD

CONTACT

+34 948 425 600; iibero@unav.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: May 26, 2026
• Primary Completion (Estimated): June 25, 2026
• Study Completion (Estimated): June 25, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)