Absorption Profiles of Three Polyphenol Preparations With and Without Pollen Shell Covering
Investigation Into Polyphenol Absorption Profiles
This study consists of two parts. The first part of the study looked at the absorption of three different polyphenol preparations into the blood, the variability of their absorption and whether their absorption could be enhanced by mixing with pollen shells. For this purpose 12 healthy volunteers were recruited. All participants received all the 3 supplements with and without mixing with pollen shells so they had a total of 3 tests. For each test six blood samples were taken over an 8 hour period. Urine samples were also collected.
Oligopin was selected from the first study. The second part of study aims to look at the effects of Oligopin on endothelial function by assessing vascular tone and function in healthy volunteers using a non-invasive, direct measurement of vasodilatory capacity (EndoPAT). Nitrate and nitrite measurements, as well as blood pressure measurements, will also be recorded to provide a clear clinical assessment of the effects of this preparation (if any) upon vascular function. The effects of Oligopin will be compared to a placebo (methylcellulose-filled capsules) to allow a robust assessment of any clinical effects. A total of 24 healthy volunteers will be recruited for this study.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study consists of two parts. The first part of the study looked at the absorption of three different polyphenol preparations into the blood, the variability of their absorption and whether their absorption could be enhanced by mixing with pollen shells (pollen shells have been shown to enhance lipid molecule absorption). For this purpose 12 healthy volunteers were recruited. All participants received all the 3 supplements with and without mixing with pollen shells so they had a total of 3 tests. For each test six blood samples were taken over an 8 hour period. Urine samples were also collected.
Oligopin was selected from the first study. The second part of study aims to look at the effects of Oligopin on endothelial function by assessing vascular tone and function in healthy volunteers using a non-invasive, direct measurement of vasodilatory capacity (EndoPAT). Nitrate and nitrite measurements, as well as blood pressure measurements, will also be recorded to provide a clear clinical assessment of the effects of this preparation (if any) upon vascular function. The effects of Oligopin will be compared to a placebo (methylcellulose-filled capsules) to allow a robust assessment of any clinical effects. A total of 24 healthy volunteers will be recruited for this study.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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East Yorkshire
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Hull, East Yorkshire, Reino Unido, HU3 2RW
- Michael White Centre for Diabetes and Endocrinology
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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:
- Male or Female subjects between the age of 18-65 who can speak and understand English
- No concomitant medication including herbal medicines and food supplements
- No concomitant disease processes
- Body Mass Index 21- 29kg/m2
- Systolic blood pressure ≤150 mm Hg and diastolic pressure <90 mm Hg
- Subjects who have given informed consent
Exclusion Criteria:
- Patients not wishing to allow disclosure to their GPs.
- Concomitant medication including herbal medicines and food supplements
- Concomitant disease processes
- History of drug/alcohol abuse or Alcohol intake within 24 hours of dosing visit (visits 2-4)
- Body Mass Index <21 and > 29kg/m2
- Systolic blood pressure >150 mm Hg and or a diastolic pressure>90 mm Hg
- Unable to tolerate polyphenol products or adhere to low polyphenol diet
- Vegetarian
- Subjects not willing or able to fast until 12 noon (a total of 14 hours).
- Pregnant females or planning to conceive in the next 3 months.
- Participation in any other study currently or in the last three months.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Polyphenol
Polyphenol preparations
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Polyphenol
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Area Under the Absorption Curve for each polyphenol preparation
Periodo de tiempo: 8 hours
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Blood samples will be withdrawn 6 times over an 8 hour period: baseline, then 30 minutes, 1 hour, 2 hours, 4 hours and 8 hours after ingestion of each polyphenol supplement (total 3 supplements)
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8 hours
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Thozhukat Sathyapalan, MBBS FRCP MD, University of Hull
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 (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- Protocol Version 2
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