Effect of a Pomegranate Extract on Cardiovascular Risk Markers in Overweight Healthy Subjects (POMEcardio)
Effect of an Ellagitannin Rich Pomegranate Extract on Cardiovascular Risk Markers in Overweight Healthy Subjects. A Double-blind, Cross-over, Dose-response, Randomized, Placebo-controlled Trial (The POMEcardio Study)
The investigators objective is to carry out a placebo-controlled, dose-response, randomized clinical trial to assess the effects of polyphenols or derived metabolites on cardiovascular disease risk in overweight adult subjects upon the consumption of pomegranate extract.
The investigators hypothesis is that chronic consumption of a ellagitannin-rich source such as pomegranate extract could decrease serum oxidized-LDL as well as other inflammatory markers. The correlation between the effect exerted and the subjects' microbiota (capacity to produce the ellagitannin-derived metabolites urolithins) will indicate a possible role of urolithins on the effects.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
- Suplemento dietético: Pomegranate extract-first dose-Group A
- Suplemento dietético: Pomegranate extract-first dose-Group B
- Suplemento dietético: Pomegranate extract-second dose-Group A
- Suplemento dietético: Pomegranate extract-second dose-Group B
- Suplemento dietético: Placebo-first dose-Group B
- Suplemento dietético: Placebo-first dose-Group A
- Suplemento dietético: Placebo-second dose-Group B
- Suplemento dietético: Placebo-second dose-Group A
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Murcia, España, 30107
- UCAM (San Antonio Catholic University from Murcia)
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Aged 40-65 years
- Body mass index (BMI) >27 kg/m2
- Healthy status (no illness in the previous 3-months).
Exclusion Criteria:
- Smoking.
- Pregnancy/lactation.
- Severe medical illness/chronic disease/ or gastrointestinal pathology (ulcers, irritable bowel syndrome, ulcerative colitis, Crohn disease etc.).
- Previous gastrointestinal surgery
- Recent use of antibiotics (within 1-month prior to the study)
- Suspected hypersensitivity to pomegranate or any of its components
- Consumption of nutraceuticals, botanical extracts or other vitamin supplements or taking medication.
- Regular consumption of ellagitannin-containing foodstuffs (walnuts, pomegranate, strawberries, raspberries, oak-aged red wine) (after filling a food-frequency questionnaire).
- Intake of ellagitannins-containing foodstuffs the week before the pharmacokinetic intervention.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Pomegranate extract
Crossover and dose-response: Both groups A and B will consume pomegranate extract and placebo. Both groups will also consume two doses of pomegranate extract and placebo. Group A will consume 1 daily capsule of pomegranate extract and group B will consume 1 daily capsule of placebo for 3 weeks. After a wash-out period of 3 weeks, group A will consume 1 daily capsule of placebo and group B will consume 1 daily capsule of pomegranate extract for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of pomegranate extract for 3 weeks and group B will consume 4 daily capsules of placebo for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of placebo for 3 weeks and group B will consume 4 daily capsules of pomegranate for 3 weeks. |
Group A will consume 1 daily capsule of pomegranate extract for 3 weeks
Otros nombres:
After 3 weeks of washout, group B will consume 1 daily capsule of pomegranate extract for 3 weeks.
Otros nombres:
After 3 weeks of washout, group A will consume 4 daily capsules of pomegranate extract for 3 weeks.
Otros nombres:
After 3 weeks of washout, group B will consume 4 daily capsules of pomegranate extract for 3 weeks.
Otros nombres:
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Comparador de placebos: Placebo
Crossover and dose-response: Both groups A and B will consume pomegranate extract and placebo. Both groups will also consume two doses of pomegranate extract and placebo. Group A will consume 1 daily capsule of pomegranate extract and group B will consume 1 daily capsule of placebo for 3 weeks. After a wash-out period of 3 weeks, group A will consume 1 daily capsule of placebo and group B will consume 1 daily capsule of pomegranate extract for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of pomegranate extract for 3 weeks and group B will consume 4 daily capsules of placebo for 3 weeks. After a washout period of 3 weeks, group A will consume 4 daily capsules of placebo for 3 weeks and group B will consume 4 daily capsules of pomegranate for 3 weeks. |
Group B will consume 1 daily capsules of placebo for 3 weeks.
Otros nombres:
After 3 weeks of washout, group A will consume 1 daily capsule of placebo for 3 weeks.
Otros nombres:
After 3 weeks of washout, group B will consume 4 daily capsules of placebo for 3 weeks.
Otros nombres:
After 3 weeks of washout, group A will consume 4 daily capsules of placebo for 3 weeks.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in serum oxidized LDL-cholesterol concentration
Periodo de tiempo: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Effect on circulating levels of oxidized particles of LDL-cholesterol
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Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in serum lipids and lipoproteins levels
Periodo de tiempo: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Effects on serum total cholesterol, LDL-cholesterol, HDL-cholesterol and apolipoproteins A1 (ApoA1), B (ApoB) and E (ApoE).
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Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Change in serum sICAM, sVCAM and hsCRP
Periodo de tiempo: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Effect on soluble intercellular adhesion molecule (sICAM), soluble vascular adhesion molecule (sVCAM) and high-sensitivity C-reactive protein (hsCRP)
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Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Change in fecal microbiota
Periodo de tiempo: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Prebiotic effect: Change in short fatty acids, bifidobacteria, lactobacilli and other selected species in feces
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Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Number of volunteers with adverse events as a measure of safety and tolerability
Periodo de tiempo: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Change in phenolics and derived metabolites in plasma, feces and urine.
Periodo de tiempo: Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Dose-response effect of pomegranate intake on phenolics and gut-microbiota derived metabolites in plasma, feces and urine.
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Change from baseline at 3, 6, 9, 12, 15, 18, 21 and 24 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Dr. Juan Carlos Espín, PhD, National Research Council (CEBAS-CSIC, Murcia, Spain)
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CEBAS-CSIC-4
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