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Completed

NCT Number: NCT01829542

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

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.

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Key information

Conditions

Endothelial Function

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hugh Sinclair Unit of Human Nutrition

Reading, Berkshire, RG6 6AP, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Freeze-dried blueberry powder dissolved in water

Dietary Supplement

Wild blueberry freeze-dried powder dissolved in water

Control

Dietary Supplement

Macro- and micro-nutrient matched control in water

Primary outcomes

  1. Flow-mediated dilation

    Time frame: 0-1 hour after consumption

Secondary outcomes

  1. plasma blueberry polyphenol metabolites

    Time frame: 0-1 h after consumption

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • Alpro Foundation

Registry information

Acronym: BB2

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 11, 2013
Registry last updated
Apr 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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