Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
Healthy Volunteers
ID07615673

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

Led by Iziar Amaia Ludwig Sanz Orrio · Updated on 2026-06-03

16

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

I

Iziar Amaia Ludwig Sanz Orrio

Lead Sponsor

M

Ministerio de Ciencia e Innovación, Spain

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying how polyphenols from artichoke by-products are absorbed, distributed, metabolized, and excreted in healthy adults. This research aims to identify active compounds and their metabolites in the body after taking a supplement rich in hydroxycinnamic acids (HCAs), helping to understand differences in metabolic responses among individuals. Participants will follow a low-polyphenol diet for 48 hours before and after taking the supplement to reduce background intake. On the study day, volunteers will consume six capsules containing dehydrated artichoke powder providing 197.4 mg of HCAs after fasting overnight. Blood samples will be collected at baseline and multiple times up to 48 hours after intake, while urine samples will be gathered over specified intervals before and after taking the supplement. During the study, researchers will analyze blood and urine samples using advanced laboratory techniques to detect and measure HCAs and their metabolites. Participants will be monitored for changes in these compounds over time. The study focuses on understanding the bioavailability of these compounds through detailed sample collection and analysis over a total period of 96 hours including dietary restrictions and sample collection phases.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women between 18 and 75 years of age.
  • Normal-weight volunteers with a BMI of 18.5-24.9 kg/m².
  • Ability to understand and willingness to sign the informed consent form.
  • Willingness to comply with all study procedures and requirements.
Not Eligible

You will not qualify if you...

  • Presence of chronic gastrointestinal pathology.
  • Lactating or pregnant women, or those planning to become pregnant.
  • Antibiotic use within 3 months prior to the study.
  • Current use of supplements (plant-derived, fiber, or probiotics) unless discontinued during the study and with a 14-day washout before baseline.
  • Alcohol intake greater than 80 grams per day.
  • Allergy or intolerance to artichoke.
  • Treatment with anticoagulants, immunosuppressants, or cytotoxic agents.
  • Renal or hepatic failure.
  • Immunodeficiency or HIV positive status.
  • Any type of cancer or cancer treatment within the past 5 years.
  • Weight loss greater than 5% in the 6 months before the trial.
  • Lack of time or geographic availability for study visits.
  • Failure to sign the informed consent form.
  • Difficulty undergoing blood collection.
  • Blood donation within 14 days prior to baseline visit.
  • Difficulty swallowing capsules or similar forms of medication.

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 2 days of diet plus 48 hours post-intake

Participants follow a low-polyphenol diet for two days before and during the 48 hours of the dietary intervention. After fasting overnight, participants consume a single dose of 6 capsules of dehydrated artichoke by-product with water.

1 baseline visit and multiple sample collections over 48 hours

Post-treatment Monitoring

Duration - 48 hours

Participants provide blood and urine samples at specified intervals up to 48 hours after intake to assess biomarkers of polyphenol intake.

Blood samples at baseline, 1, 2, 4, 7, 24, and 48 hours; urine samples collected at 24 hours pre-intake, and multiple intervals up to 48 hours post-intake

Trial Site Locations

Total: 1 location

1

Universidad de Navarra

Pamplona, Navarre, Spain, 31008

Actively Recruiting

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Research Team

I

Iziar A Ludwig, PhD

I

Idoia Ibero, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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