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Completed

NCT Number: NCT02764749

Cranberry (Poly)Phenol Consumption on Vascular Function

Epidemiological studies suggest that the consumption of (poly)phenols rich foods such as cocoa, tea, fruits and vegetables is associated with lower blood pressure, reduced cholesterol and decreased cardiovascular risk. Cranberries are a rich source of (poly)phenols, including anthocyanins, proanthocyanidins and phenolic acids. Whether cranberries can improve vascular function 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 cranberries can improve endothelial function, a prognostically validated surrogate of cardiovascular risk. This study also aims to reveal which cranberry (poly)phenols have bioactive properties in healthy men. Consequently, plasma and urine metabolite peaks will be correlated with vascular outcomes and genome-wide expression microarrays will be performed to reveal cell signaling pathways associated with cranberry (poly)phenol-mediated cardioprotective events.

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Key information

Conditions

Age range

18 year–35 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 (no clinical signs or symptoms of CVD)
  • Young >18 years, <35 years

Exclusion criteria

  • CVD
  • acute inflammation
  • cardiac arrhythmia
  • renal failure
  • heart failure (NYHA II-IV)
  • diabetes mellitus
  • CRP > 1 mg/dl
  • malignant disease

Treatment and study plan

cranberry (poly)phenol containing supplement

Dietary Supplement

Sustained intake of 9 grams of freeze-dried cranberry powder per day (2x 4.5 grams daily over 1 month). The powder is dissolved in water and administered as a drink.

Placebo comparator: cranberry (poly)phenol deprived supplement

Dietary Supplement

Sustained intake (2x 4.5 grams daily over 1 month) of a control supplement dissolved in water

Primary outcomes

  1. Change form Baseline Endothelial function at 1 month

    Time frame: 2 hours and 1 month

    Measured by Flow mediated dilation (FMD)

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 1month

    automatical measurements 0 and 2 hours postconsumption

  3. high density lipoproteins (HDL)

    Time frame: Baseline and 1 month

    measured on baseline and after 1 month

  4. low density lipoproteins (LDL)

    Time frame: Baseline and 1 month

    measured on baseline and after 1 month

  5. triglyceride

    Time frame: Baseline and 1 month

    measured on baseline and after 1 month

Other outcomes

  1. Plasma cranberry (poly)phenol metabolites

    Time frame: Baseline and 1 month

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

  2. Urinary cranberry (poly)phenol metabolites

    Time frame: Baseline and 1 month

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

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Official study title

Sustained Effects of Cranberry (Poly)Phenol Consumption on Vascular Function in Healthy Individuals

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 6, 2016
Registry last updated
Nov 28, 2016

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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