Dose-dependent Effects of Blueberry Polyphenols on Endothelial Function in Healthy Individuals (BB2)

April 10, 2013 updated by: Jeremy Paul Edward Spencer, University of Reading
The purpose of this study is to assess the impact of acute blueberry polyphenol intake on endothelial function of healthy volunteers. Specifically, the investigators plan to perform a randomised, double blind, cross-over human intervention trial using a blueberry drink to investigate the dose-dependent effects of blueberry polyphenols on blood vessel function using Flow mediated dilation (FMD) to measure endothelial function. The study will not only measure the acute effects of flavonoid ingestion on vascular reactivity but will also assess plasma polyphenol metabolite levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG6 6AP
        • Hugh Sinclair Unit of Human Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male
  • 18-40 years
  • Healthy
  • signed consent form

Exclusion Criteria:

  • Blood pressure > 140/90 mmHg
  • Had suffered a myocardial infarction or stroke
  • Suffers from any blood-clotting disorder
  • Suffers from any metabolic disorders (e.g. diabetes or any other endocrine or liver diseases)
  • Any dietary restrictions or on a weight reducing diet
  • Allergies or intolerances to any foods
  • Smoker
  • Heavy drinker (>21 units per week)
  • On any lipid-modifying medication
  • On any blood pressure lowering medication
  • On any medication affecting blood clotting
  • Taking high dose fish oil supplements (greater then 1 g EPA and DHA per day) or high doses of antioxidant vitamins (greater then 800 μg vitamin A, 60 mg vitamin C, 10 mg vitamin E or 400 μg beta carotene)
  • Taking probiotics, prebiotics, synbiotics, antibiotics or anti-inflammatory or blood lowering medication within a 2-month period prior to the study
  • Planning on altering consumption of vitamin supplements/fish oil capsules during the course of the study
  • Undertakes strenuous exercise > 4 times per week for > 1 hour per session
  • Haemoglobin levels below reference range provided by the Royal Berkshire Hospital

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 319 mg blueberry polyphenols
Freeze-dried blueberry powder dissolved in water
Dietary supplement: Freeze-dried blueberry powder dissolved in water
Wild blueberry freeze-dried powder dissolved in water
Active Comparator: 639 mg blueberry polyphenols
Freeze-dried blueberry powder dissolved in water
Dietary supplement: Freeze-dried blueberry powder dissolved in water
Wild blueberry freeze-dried powder dissolved in water
Active Comparator: 766 mg blueberry polyphenols
Freeze-dried blueberry powder dissolved in water
Dietary supplement: Freeze-dried blueberry powder dissolved in water
Wild blueberry freeze-dried powder dissolved in water
Active Comparator: 1466 mg blueberry polyphenols
Freeze-dried blueberry powder dissolved in water
Dietary supplement: Freeze-dried blueberry powder dissolved in water
Wild blueberry freeze-dried powder dissolved in water
Active Comparator: 1791 mg total blueberry polyphenols
Freeze-dried blueberry powder dissolved in water
Dietary supplement: Freeze-dried blueberry powder dissolved in water
Wild blueberry freeze-dried powder dissolved in water
Placebo Comparator: O mg blueberry polyphenols
Macro- and micronutrient matched control drink
Dietary supplement: Control
Macro- and micro-nutrient matched control in water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Flow-mediated dilation
Time Frame: 0-1 hour after consumption
0-1 hour after consumption

Secondary Outcome Measures

Outcome Measure
Time Frame
plasma blueberry polyphenol metabolites
Time Frame: 0-1 h after consumption
0-1 h after consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Reading

Collaborators

Alpro Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

April 8, 2013

First Submitted That Met QC Criteria

April 10, 2013

First Posted (Estimate)

April 11, 2013

Study Record Updates

Last Update Posted (Estimate)

April 11, 2013

Last Update Submitted That Met QC Criteria

April 10, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BB2UReading

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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