Exploration of Potential Biomarkers of Polyphenol Intake From Artichoke By-product Supplements
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Single intake of a supplement derived from artichoke by-products.
- Who it may be relevant to
- Registry conditions: Healthy Adult Participants, ADME, Polyphenols Absorption Profile, Polyphenolic Compounds and Metabolism. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Exploration of Potential Biomarkers of Polyphenol Intake From a Supplement Derived From Artichoke By-products Rich in Hydroxycinnamic Acids
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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 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 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]
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Spain · 1 center
- Universidad de Navarra — Pamplona
Identifiers
NCT: NCT07615673 · ARTI-UP ADME