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

NCT ID: NCT02116816

Last Updated: 2019-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-05-31

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.

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

Polyphenols Absorption Profile

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Polyphenol

Polyphenol preparations

Group Type: EXPERIMENTAL

Polyphenol

Intervention Type: DIETARY_SUPPLEMENT

Polyphenol

Interventions

Polyphenol

Polyphenol

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hull University Teaching Hospitals NHS Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thozhukat Sathyapalan, MBBS FRCP MD

Role: PRINCIPAL_INVESTIGATOR

University of Hull

Locations

Michael White Centre for Diabetes and Endocrinology

Hull, East Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

Protocol Version 2

Identifier Type: -

Identifier Source: org_study_id