Polyphenols Absorption Profile Clinical Trial
Official title:
Investigation Into Polyphenol Absorption Profiles
| NCT number | NCT02116816 |
| Other study ID # | Protocol Version 2 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 2014 |
| Est. completion date | May 2015 |
| Verified date | July 2019 |
| Source | Hull and East Yorkshire Hospitals NHS Trust |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | May 2015 |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Michael White Centre for Diabetes and Endocrinology | Hull | East Yorkshire |
| Lead Sponsor | Collaborator |
|---|---|
| Hull and East Yorkshire Hospitals NHS Trust |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |