Exploration of Potential Biomarkers of Polyphenol Intake From Artichoke By-product Supplements (ARTI-UP ADME)
1 juni 2026 uppdaterad av: Iziar Amaia Ludwig Sanz Orrio
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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
16
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Iziar A Ludwig, PhD
- Telefonnummer: 806652 +34 948425600
- E-post: uinclint@unav.es
Studera Kontakt Backup
- Namn: Idoia Ibero, PhD
- Telefonnummer: 806699 +34 948 425 600
- E-post: iibero@unav.es
Studieorter
-
-
Navarre
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Pamplona, Navarre, Spanien, 31008
- Rekrytering
- Universidad de Navarra
-
Kontakt:
- Idoia Ibero, PhD
- Telefonnummer: 806699 +34 948 425 600
- E-post: iibero@unav.es
-
Kontakt:
- Iziar A Ludwig, PhD
- Telefonnummer: 806652 +34 948 425600
- E-post: iludwig@unav.es
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in the qualitative identification of HCAs and their metabolites of dehydrated artichoke by-product in urine between baseline and 48 h post-consumption
Tidsram: Baseline, 0-4 hours, 4-7 hours, 7-12 hours, 12-24 hours, and 24-48 hours
|
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
Tidsram: Baseline, 1 hours, 2 hour, 4 hours, 7 hours, 24 hours, and 48 hours
|
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
Tidsram: Baseline, 1 hours, 2 hour, 4 hours, 7 hours, 24 hours, and 48 hours
|
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
Tidsram: Baseline, 0-4 hours, 4-7 hours, 7-12 hours, 12-24 hours, and 24-48 hours
|
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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Iziar A Ludwig Sanz-Orrio, University of Navarra
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
26 maj 2026
Primärt slutförande (Beräknad)
25 juni 2026
Avslutad studie (Beräknad)
25 juni 2026
Studieregistreringsdatum
Först inskickad
22 maj 2026
Först inskickad som uppfyllde QC-kriterierna
22 maj 2026
Första postat (Faktisk)
29 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
3 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
1 juni 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- ARTI-UP ADME
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
Anonymized individual data on the bioavailability and metabolism of HCAs will only be shared if noteworthy inter-individual variability is detected.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .