Clinical Trials Directory

Trials / Completed

CompletedNCT02116816

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

Investigation Into Polyphenol Absorption Profiles

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
Hull University Teaching Hospitals NHS Trust · Other Government
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTPolyphenolPolyphenol

Timeline

Start date
2014-04-01
Primary completion
2015-05-01
Completion
2015-05-01
First posted
2014-04-17
Last updated
2019-07-16

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT02116816. Inclusion in this directory is not an endorsement.