GreenArt: Nutrikinetics and Bioavailability Studies
26 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
- Suplemento dietético: GreenArt D is a baccharis-type propolis powder extract containing phenolic compounds such as prenylated phenylpropanoids derived from hydroxycinnamic acids and flavonoids.
- Suplemento dietético: GreenArt 4D is a baccharis-type propolis powder extract containing phenolic compounds such as prenylated phenylpropanoids derived from hydroxycinnamic acids and flavonoids.
- Suplemento dietético: Placebo
Tipo de estudio
Intervencionista
Inscripción (Estimado)
10
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Julien Cases, PhD
- Número de teléfono: +33467219098
- Correo electrónico: jcases@biotexia.com
Ubicaciones de estudio
-
-
Murcia
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Guadalupe, Murcia, España, 30107
- UCAM Universidad Católica San Antonio de Murcia
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Contacto:
- Linda H. Chung, PhD
- Número de teléfono: + 34 968 278 611
- Correo electrónico: lhchung@ucam.edu
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Male and female with 40% min. and 60% max. of each sex.
- Aged 25 to 69 years old
- BMI range (18.5 - 29.99)
- In good general health as evidenced by medical history
- Ability to take oral supplementation and be willing to adhere to the regimen
- Agreement to adhere to Lifestyle Considerations (controlled diet) throughout study duration
Exclusion Criteria:
- Current use of any medication or food supplement
- Antibiotic use less than 12 weeks before the study
- Pregnancy or lactation
- Known allergic reactions to components of the supplement, i.e., bee products (specially propolis) and known allergy (general)
- Metabolic disorders or any kind of disease
- Current smoker
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: GreenArt D
This arm receives 150 mg of GreenArt, a baccharis-type propolis phenolic extract
|
GreenArt D contains 150 mg of GreenArt
|
|
Experimental: GreenArt 4D
This arm receives 600 mg of GreenArt, a baccharis-type propolis phenolic extract
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GreenArt 4D contains 600 mg of GreenArt
|
|
Comparador de placebos: Placebo
This arm receives 150 mg of mix carriers of the GreenArt ingredient, a baccharis-type propolis phenolic extract
|
Placebo is composed of the carriers of GreenArt : gum arabic, sucrose and silicon dioxide mix.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in plasma area under the curve (AUC) of phenolic metabolites after acute ingestion of the supplement/placebo
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de junio de 2026
Finalización primaria (Estimado)
1 de julio de 2026
Finalización del estudio (Estimado)
1 de julio de 2026
Fechas de registro del estudio
Enviado por primera vez
26 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
26 de junio de 2026
Publicado por primera vez (Actual)
2 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
2 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
26 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GREENKBA
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .