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GreenArt: Nutrikinetics and Bioavailability Studies

26 juni 2026 bijgewerkt door: Fytexia

Baccharis-type Propolis Extract, GreenArt: Nutrikinetics and Bioavailability Studies

The aim of this study is to investigate phenolic compounds from GreenArt, a baccharis-type propolis ingredient, bioavailability and nutrikinetics by measuring urinary excretion and metabolic profile over 48h by means of high-performance liquid chromatography coupled with tandem mass spectrometry (HPLC-MS/MS). The study follows a cross-over, double-blind, randomized and placebo control design on 10 healthy subjects.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

10

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Spanje
    • Murcia
      • Guadalupe, Murcia, Spanje, 30107
        • UCAM Universidad Católica San Antonio de Murcia
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusion Criteria:

  1. Provision of signed and dated informed consent form.
  2. Stated willingness to comply with all study procedures and availability for the duration of the study.
  3. Male and female with 40% min. and 60% max. of each sex.
  4. Aged 25 to 69 years old
  5. BMI range (18.5 - 29.99)
  6. In good general health as evidenced by medical history
  7. Ability to take oral supplementation and be willing to adhere to the regimen
  8. Agreement to adhere to Lifestyle Considerations (controlled diet) throughout study duration

Exclusion Criteria:

  1. Current use of any medication or food supplement
  2. Antibiotic use less than 12 weeks before the study
  3. Pregnancy or lactation
  4. Known allergic reactions to components of the supplement, i.e., bee products (specially propolis) and known allergy (general)
  5. Metabolic disorders or any kind of disease
  6. Current smoker

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: GreenArt D
This arm receives 150 mg of GreenArt, a baccharis-type propolis phenolic extract
Voedingssupplement: GreenArt D is a baccharis-type propolis powder extract containing phenolic compounds such as prenylated phenylpropanoids derived from hydroxycinnamic acids and flavonoids.
GreenArt D contains 150 mg of GreenArt
Experimenteel: GreenArt 4D
This arm receives 600 mg of GreenArt, a baccharis-type propolis phenolic extract
Voedingssupplement: GreenArt 4D is a baccharis-type propolis powder extract containing phenolic compounds such as prenylated phenylpropanoids derived from hydroxycinnamic acids and flavonoids.
GreenArt 4D contains 600 mg of GreenArt
Placebo-vergelijker: Placebo
This arm receives 150 mg of mix carriers of the GreenArt ingredient, a baccharis-type propolis phenolic extract
Voedingssupplement: Placebo
Placebo is composed of the carriers of GreenArt : gum arabic, sucrose and silicon dioxide mix.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in plasma area under the curve (AUC) of phenolic metabolites after acute ingestion of the supplement/placebo
Tijdsspanne: Baseline (pre-ingestion) to 24 hour post-ingestion
Plasma samples will be collected in EDTA tubes in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame. Phenolic compounds metabolites in plasma will be identified and quantified by HPLC-MS. Targeted metabolites are prenylated phenolic acids, phenolic acids and flavonoids derivatives. For each identified and quantified metabolite the area under the curve (0-24 hour) in nmol/L-h is measured.
Baseline (pre-ingestion) to 24 hour post-ingestion
Change in plasma maximal concentration (Cmax) of phenolic metabolites after acute ingestion of the supplement/placebo
Tijdsspanne: Baseline (pre-ingestion) and 0.5 hour, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 24 hour post-ingestion
Plasma samples will be collected in EDTA tubes in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame. Phenolic compounds metabolites in plasma will be identified and quantified by HPLC-MS. Targeted metabolites are prenylated phenolic acids, phenolic acids and flavonoids derivatives. For each identified and quantified metabolite the maximal concentration in nmol/L is measured.
Baseline (pre-ingestion) and 0.5 hour, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 24 hour post-ingestion
Change in plasma time to reach maximal concentration (Tmax) of phenolic metabolites after acute ingestion of the supplement/placebo
Tijdsspanne: Baseline (pre-ingestion) and 0.5 hour, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 24 hour post-ingestion
Plasma samples will be collected in EDTA tubes in baseline before supplement/placebo intake (0h) and up to 24h according to the time frame. Phenolic compounds metabolites in plasma will be identified and quantified by HPLC-MS. Targeted metabolites are prenylated phenolic acids, phenolic acids, and flavonoids derivatives. For each identified and quantified metabolite the time to reach maximum concentration in hour is measured.
Baseline (pre-ingestion) and 0.5 hour, 1 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 10 hour, 24 hour post-ingestion
Change in urine area under the curve (AUC) phenolic metabolites excretion after acute ingestion of the supplement/placebo
Tijdsspanne: Baseline (pre-ingestion) to 48 hour post-ingestion
Urine samples will be collected in baseline (0h pre-ingestion) and up to 48h according to the time frame. Phenolic compounds metabolites in urine will be identified and quantified by HPLC-MS. Targeted metabolites are prenylated phenolic acids, phenolic acids and flavonoids derivatives. For each identified and quantified metabolite the area under the curve (0-24 hour) in nmol/L-h is measured.
Baseline (pre-ingestion) to 48 hour post-ingestion
Change in urine maximal concentration (Cmax) phenolic metabolites excretion after acute ingestion of the supplement/placebo
Tijdsspanne: Baseline (pre-ingestion) and 0 hour - 3 hour, 3 hour - 6 hour, 6 hour - 10 hour, 10 hour - 14 hour, 14 hour - 24 hour, 24 hour - 36 hour and 36 hour - 48 hour post-ingestion
Urine samples will be collected in baseline (0h pre-ingestion) and up to 48h according to the time frame. Phenolic compounds metabolites in urine will be identified and quantified by HPLC-MS. Targeted metabolites are penylated phenolic acids, phenolic acids and flavonoids derivatives. For each identified and quantified metabolite the maximal concentration in nmol/L is measured.
Baseline (pre-ingestion) and 0 hour - 3 hour, 3 hour - 6 hour, 6 hour - 10 hour, 10 hour - 14 hour, 14 hour - 24 hour, 24 hour - 36 hour and 36 hour - 48 hour post-ingestion
Change in urine time to reach maximal concentration (Tmax) phenolic metabolites excretion after acute ingestion of the supplement/placebo
Tijdsspanne: Baseline (pre-ingestion) and 0 hour - 3 hour, 3 hour - 6 hour, 6 hour - 10 hour, 10 hour - 14 hour, 14 hour - 24 hour, 24 hour - 36 hour and 36 hour - 48 hour post-ingestion
Urine samples will be collected in baseline (0h pre-ingestion) and up to 48h according to the time frame. Phenolic compounds metabolites in urine will be identified and quantified by HPLC-MS. Targeted metabolites are prenylated phenolic acids, phenolic acids and flavonoids derivatives. For each identified and quantified metabolite the time to reach maximum concentration in hour is measured.
Baseline (pre-ingestion) and 0 hour - 3 hour, 3 hour - 6 hour, 6 hour - 10 hour, 10 hour - 14 hour, 14 hour - 24 hour, 24 hour - 36 hour and 36 hour - 48 hour post-ingestion

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Fytexia

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

1 juli 2026

Studie voltooiing (Geschat)

1 juli 2026

Studieregistratiedata

Eerst ingediend

26 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

26 juni 2026

Eerst geplaatst (Werkelijk)

2 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

26 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • GREENKBA

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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