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

NCT02116816 | Completed

• 1 other identifier: Protocol Version 2
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Polyphenols Absorption Profile

Outcome Measures

Primary Outcomes (1)

• Area Under the Absorption Curve for each polyphenol preparation

  Blood samples will be withdrawn 6 times over an 8 hour period: baseline, then 30 minutes, 1 hour, 2 hours, 4 hours and 8 hours after ingestion of each polyphenol supplement (total 3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

Study Arms (1)

Polyphenol

EXPERIMENTAL

Polyphenol preparations

Dietary Supplement: Polyphenol

Interventions

Polyphenol DIETARY_SUPPLEMENT

Polyphenol

Polyphenol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead

Study Sites (1)

Michael White Centre for Diabetes and Endocrinology

Hull, East Yorkshire, HU3 2RW, United Kingdom

Location

MeSH Terms

Interventions

Polyphenols

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Thozhukat Sathyapalan, MBBS FRCP MD

  University of Hull

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: April 17, 2014
• Study Start: April 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 16, 2019

Record last verified: 2019-07

Locations

GB (1)