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Completed

NCT Number: NCT02116816

Absorption Profiles of Three Polyphenol Preparations With and Without Pollen Shell Covering

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Michael White Centre for Diabetes and Endocrinology

Hull, East Yorkshire, HU3 2RW, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Polyphenol

Dietary Supplement

Polyphenol

Primary outcomes

  1. Area Under the Absorption Curve for each polyphenol preparation

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Hull University Teaching Hospitals NHS Trust

Other Gov

Registry information

Official study title

Investigation Into Polyphenol Absorption Profiles

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 17, 2014
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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