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OpenTrials
Completed

NCT Number: NCT02520830

Effects of Blueberry-polyphenols on Endothelial Function, Absorption and Metabolism

Diets rich in fruits and vegetables have been linked to favorable cardiovascular outcomes in epidemiological studies.

Dietary intervention studies with certain micronutrients have shown promising effects on surrogate parameters of vascular risk including blood pressure, endothelial function and cholesterol levels. Wild blueberries have gained attention due to their high content of phytochemicals and particularly anthocyanins. Whether wild blueberries can improve vascular function and health when given over relevant time periods and in relevant populations is not known. Therefore, it is the overall hypothesis of the study proposal that chronic consumption of wild blueberries can improve endothelial function, a prognostically validated surrogate of cardiovascular risk.

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Key information

Conditions

Healthy

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Division of Cardiology, Pulmonary Disease and Vascular Medicine, University Hospital Duesseldorf

Düsseldorf, 40225, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy male subjects without clinical signs or symptoms of cardiovascular disease
  • 18-70 years

Exclusion criteria

  • cardiovascular disease
  • acute inflammation
  • cardiac arrhythmia
  • renal failure
  • heart failure (NYHA II-IV)
  • diabetes mellitus
  • C- reactive protein > 1mg/dl
  • malignant disease

Treatment and study plan

Blueberry Group

Dietary Supplement

22 grams freeze-dried blueberry powder per day. Sustained intake (2x 11 grams daily over 1 month) of a drink consisting on freeze-dried wild blueberry powder dissolved in water

Placebo Group

Dietary Supplement

Sustained intake (2x 11 grams daily over 1 month) of a drink consisting in placebo powder dissolved in water

Primary outcomes

  1. Endothelial function

    Time frame: baseline and 1 month

    Determination of endothelial function by Flow mediated dilation (FMD) 0 and 2 hours postconsumption

Secondary outcomes

  1. Pulse wave velocity

    Time frame: baseline and 1 month

    Measured by SphygmoCor 0 and 2 hours postconsumption

  2. Blood pressure

    Time frame: baseline and 1 month

    automatical measurements, 0 and 2 hours postconsumption

  3. Blood lipids

    Time frame: baseline and 1 month

    biochemical analysis, 0 and 2 hours postconsumption

Other outcomes

  1. Plasma blueberry polyphenol metabolites

    Time frame: baseline and 1 month

    measured by liquid chromotography- mass spectrometry (LC/MS) 0 and 2 hours postconsumption

  2. Peripheral blood mononuclear cell-derived gene expression analysis

    Time frame: baseline and 1 month

    exploratory measures; measured by Agilent Human GZ 4x44 v2 Microarray

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Official study title

Sustained Effects of Blueberry Polyphenols on Vascular Function in Healthy Individuals

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 13, 2015
Registry last updated
Nov 3, 2015

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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