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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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • East Yorkshire
      • Hull、East Yorkshire、英国、HU3 2RW
        • Michael White Centre for Diabetes and Endocrinology

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

16年 至 63年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Male or Female subjects between the age of 18-65 who can speak and understand English
  2. No concomitant medication including herbal medicines and food supplements
  3. No concomitant disease processes
  4. Body Mass Index 21- 29kg/m2
  5. Systolic blood pressure ≤150 mm Hg and diastolic pressure <90 mm Hg
  6. Subjects who have given informed consent

Exclusion Criteria:

  1. Patients not wishing to allow disclosure to their GPs.
  2. Concomitant medication including herbal medicines and food supplements
  3. Concomitant disease processes
  4. History of drug/alcohol abuse or Alcohol intake within 24 hours of dosing visit (visits 2-4)
  5. Body Mass Index <21 and > 29kg/m2
  6. Systolic blood pressure >150 mm Hg and or a diastolic pressure>90 mm Hg
  7. Unable to tolerate polyphenol products or adhere to low polyphenol diet
  8. Vegetarian
  9. Subjects not willing or able to fast until 12 noon (a total of 14 hours).
  10. Pregnant females or planning to conceive in the next 3 months.
  11. Participation in any other study currently or in the last three months.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Polyphenol
Polyphenol preparations
Polyphenol

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Area Under the Absorption Curve for each polyphenol preparation
大体时间:8 hours
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)
8 hours

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Thozhukat Sathyapalan, MBBS FRCP MD、University of Hull

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年4月1日

初级完成 (实际的)

2015年5月1日

研究完成 (实际的)

2015年5月1日

研究注册日期

首次提交

2014年4月15日

首先提交符合 QC 标准的

2014年4月15日

首次发布 (估计)

2014年4月17日

研究记录更新

最后更新发布 (实际的)

2019年7月16日

上次提交的符合 QC 标准的更新

2019年7月12日

最后验证

2019年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • Protocol Version 2

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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