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Exploration of Potential Biomarkers of Polyphenol Intake From Artichoke By-product Supplements (ARTI-UP ADME)

1. juni 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

16

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Iziar A Ludwig, PhD
  • Telefonnummer: 806652 +34 948425600
  • E-mail: uinclint@unav.es

Undersøgelse Kontakt Backup

  • Navn: Idoia Ibero, PhD
  • Telefonnummer: 806699 +34 948 425 600
  • E-mail: iibero@unav.es

Studiesteder

  • Spanien
    • Navarre
      • Pamplona, Navarre, Spanien, 31008
        • Rekruttering
        • Universidad de Navarra
        • Kontakt:
          • Idoia Ibero, PhD
          • Telefonnummer: 806699 +34 948 425 600
          • E-mail: iibero@unav.es
        • Kontakt:
          • Iziar A Ludwig, PhD
          • Telefonnummer: 806652 +34 948 425600
          • E-mail: iludwig@unav.es

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Kosttilskud: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in the qualitative identification of HCAs and their metabolites of dehydrated artichoke by-product in urine between baseline and 48 h post-consumption
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Iziar Amaia Ludwig Sanz Orrio

Samarbejdspartnere

Ministerio de Ciencia e Innovación, Spain

Efterforskere

  • Ledende efterforsker: Iziar A Ludwig Sanz-Orrio, University of Navarra

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

26. maj 2026

Primær færdiggørelse (Anslået)

25. juni 2026

Studieafslutning (Anslået)

25. juni 2026

Datoer for studieregistrering

Først indsendt

22. maj 2026

Først indsendt, der opfyldte QC-kriterier

22. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • ARTI-UP ADME

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Anonymized individual data on the bioavailability and metabolism of HCAs will only be shared if noteworthy inter-individual variability is detected.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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