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Completed

NCT Number: NCT01292954

Effect of Blueberries on Vascular Function in Healthy Men

Scientific question to be addressed: To determine the effects of acute blueberry ingestion on vascular function and blood pressure in humans

Hypothesis: Acute consumption of blueberry induces an improvement in blood pressure and vascular function through the impact of blueberry flavonoids on the vascular system.

Study objectives: To determine the dose-dependency of a blueberry drink on blood pressure and vascular function in healthy subjects and to determine pharmacokinetics of blueberry polyphenols

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Key information

Conditions

Age range

19 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Reading

Reading, Berkshire, RG6 6AP, United Kingdom

About this study

Coronary heart disease (CHD) remains one of the major causes of premature death in the world. There is now substantial evidence to indicate that the cells lining the inner surface of arteries play a major role in protection against the development and progression of CHD. This layer of cells is termed the endothelium and regulates vascular tone by promoting the expansion and contraction of the blood vessel. There are a variety of non-invasive techniques for measuring endothelial function.

Research provides evidence that consumption of a diet high in plant foods and rich in polyphenols is associated with a reduction in incidence of coronary heart disease (CHD). Polyphenols, of which the flavonoids are the largest group, are thought to play a role in the reduction of incidence of chronic diseases such as cardiovascular disease and stroke. Recent studies in humans show that flavonoid-rich foods improve peripheral blood flow and surrogate markers of cardiovascular function. These effects were associated with acute elevations in the levels of circulating nitric oxide species, an enhanced flow mediated dilatation (FMD) response of conduit arteries, and an augmented microcirculation. Increases in circulating nitric oxide species in response to flavonoid ingestion suggest that circulating flavonoids (and/or their metabolic forms) may exert positive effects on vascular tone.

The purpose of this study is to assess the impact of acute flavonoid intake on postprandial vascular reactivity 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 blueberries using a range of techniques to measure endothelial function. The study will not only measure the acute effects of flavonoid ingestion on vascular reactivity but will also assess flavonoid and metabolite levels in blood and urine and other endothelial markers.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male
  • A signed consent form
  • Age 19-40 years old
  • Body mass index - 18.5-30 kg/m2

Exclusion criteria

  • Blood pressure > 150/90 mmHg
  • Haemoglobin (anaemia marker) < 125 g/l
  • Gamma GT (liver enzymes) > 80 IU/l
  • Cholesterol > 6.5 mmol/l
  • Had suffered a myocardial infarction or stroke in the previous 12 months
  • Suffers from any reproductive disorder
  • 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
  • Drinking more than 21 units per week
  • On any medication affecting blood clotting
  • On any vitamin supplements/fish oil capsules
  • Smoking
  • Vegetarians or vegans

Treatment and study plan

Blueberries

Dietary Supplement

low dose: 31.4 g of freeze dried blueberry reconstituted in water medium dose: 57 g of freeze dried blueberry reconstituted in water high dose: 80 g of freeze dried blueberry reconstituted in water Placebo: sugars and vitamin c match control in water Frequency:1 single time Total Duration: 3 days study over 3 weeks period

Primary outcomes

  1. Flow-mediated dilation

    Time frame: 0-6 hours after consumption

Secondary outcomes

  1. Blueberry polyphenols pharmacokinetics

    Time frame: 0- 24 h after consumption

  2. Blood Pressure

    Time frame: 0-6 hours after consumption

  3. Laser Doppler Iontophoresis

    Time frame: 0-6 hours after consumption

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Collaborators

  • Alpro Foundation
  • Wild Blueberry Association of North America

Registry information

Official study title

Effects of Blueberries on Vascular Function and Blood Pressure in Healthy Men

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Feb 10, 2011
Registry last updated
Feb 10, 2011

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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