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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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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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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Polyphenol
Polyphenol preparations
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Polyphenol
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Area Under the Absorption Curve for each polyphenol preparation
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- Protocol Version 2
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