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Completed

NCT Number: NCT03041961

Aronia Berry Consumption on Vascular Function

There is an increasing interest in the effects of various food derived polyphenols on vascular function. Arguably the most well-established vascular benefits are attributed to flavanols from cocoa beans and this has been supported by a successful health claim through the European Food Safely Authority in 2012. Berry fruits are another rich source of polyphenols that have vasoactive properties, and there is a growing body of research exploring these effects in various berries (blueberries, cranberries, strawberries) and other fruit products with similar polyphenol composition. A key (poly)phenol in berries and other fruits believed to provide much of the benefit is anthocyanins. When given as an isolated extract, 320 mg anthocyanins have been found to improve blood vessel function both acutely and in response to chronic consumption over 12 weeks.

Aronia berries are a native North American berry with high naturally occurring anthocyanins among other polyphenols. Based on their polyphenol composition, there is growing interest in the potential for Aronia berries to elicit health promoting cardio-metabolic effects. Specifically, Aronia berry extracts, which provide a concentrated source of polyphenols, may improve blood vessel function.

Thus, the primary focus of this project is to evaluate the effects of Aronia berry extracts of differing polyphenol dose on vascular endothelial function.

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Key information

Conditions

Healthy Young Men

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Life Sciences and Medecine

London, Central London, SE1 9NH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy men aged 18-45 years old
  • Subjects are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study
  • Are able to understand the nature of the study
  • Able to give signed written informed consent
  • Signed informed consent form

Exclusion criteria

  • Manifest cardiovascular disease including coronary artery disease, cerebrovascular disease and peripheral artery disease
  • Hypertensive, as defined as SBP superior or equal to 140 mmHg or DBP superior or equal to 90 mmHg
  • Obese participants, defined as BMI superior or equal to 30
  • Diabetes mellitus and metabolic syndrome
  • Acute inflammation
  • Terminal renal failure
  • Malignancies
  • Abnormal heart rhythm (lower or higher than 60-100 bpm)
  • Allergies to berries or other significant food allergy.
  • Subjects under medication or on vitamin/dietary supplements.
  • Subjects who have lost more than 10% of their weight in the past 6 months or are currently in a diet
  • Subjects who reported participant in another study within one month before the study start
  • Subjects who smoke an irregular amount of cigarettes per day
  • Unable to swallow the capsule
  • Any reason or condition that in the judgment of the clinical investigator(s) may put the subject at unacceptable risk or that may preclude the subject from understanding or complying with the study's requirements.

Treatment and study plan

Placebo

Dietary Supplement

Identical formulation as the treatment consisting of colored maltodextrin using artificial colors.

Aronia full spectrum

Dietary Supplement

Powdered whole fruit obtained from aronia berries (Aronia melanocarpa)

Aronia extract

Dietary Supplement

Powdered extract obtained from aronia berries (Aronia melanocarpa)

Primary outcomes

  1. Flow-mediated dilation

    Time frame: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours

    Change form Baseline Endothelial function at 12 weeks

Secondary outcomes

  1. Pulse wave velocity

    Time frame: Baseline and 12 weeks

    Measured by SphygmoCor 0 and 2 hours postconsumption

  2. Blood pressure

    Time frame: Baseline and 12 weeks

    Automatical measurements 0 and 2 hours postconsumption

  3. Blood measurements- Blood lipids

    Time frame: Baseline and 12 weeks

    Cholesterol, HDL, LDL, triglycerides

  4. Blood measurements

    Time frame: Baseline and 12 weeks

    Haematology (White blood cell count, red blood cell count, Haemoglobin, hematocrit, platelets, neutrophils, lymphocytes, monocytes, eosinophils, basophils, reticulocytes, eosinophils

  5. Blood measurements-Electrolytes

    Time frame: Baseline and 12 weeks

    Urea, Creatinine, uric acid

  6. Blood measurements

    Time frame: Baseline and 12 weeks

    Liver values (bilirubin, lactate dehydrogenase, aspartate aminotransferase, gamma-glutamyltranspeptidase, total protein, albumine, alkaline phosphatase)

  7. Blood measurements -Glucose

    Time frame: Baseline and 12 weeks

Other outcomes

  1. Plasma aronia berry (poly)phenol metabolites

    Time frame: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours

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

  2. Microbiome analysis

    Time frame: Baseline and 12 weeks

    Stool sample collection (Umnigene gut collection kit)

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • Naturex-Dbs

Registry information

Official study title

Effects of Aronia Berry (Chokeberry) Extract on Vascular Function in Healthy Men: a 3 Month Randomized Controlled Trial.

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 3, 2017
Registry last updated
Jul 5, 2019

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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