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

1. juni 2026 oppdatert 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

16

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

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

Studer Kontakt Backup

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

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske 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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Kosttilskudd: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Iziar Amaia Ludwig Sanz Orrio

Samarbeidspartnere

Ministerio de Ciencia e Innovación, Spain

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

26. mai 2026

Primær fullføring (Antatt)

25. juni 2026

Studiet fullført (Antatt)

25. juni 2026

Datoer for studieregistrering

Først innsendt

22. mai 2026

Først innsendt som oppfylte QC-kriteriene

22. mai 2026

Først lagt ut (Faktiske)

29. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juni 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • ARTI-UP ADME

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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