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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorIziar Amaia Ludwig Sanz Orrio

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Single intake of a supplement derived from artichoke by-products

Treatment groups

16 Participants
are divided into 1 treatment group

Sponsors and collaborators

Iziar Amaia Ludwig Sanz Orrio

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Sponsor institution

Ministerio de Ciencia e Innovación, Spain

Collaborator