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Clinical Trials/NCT03041961
NCT03041961
Completed
Not Applicable

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

King's College London1 site in 1 country66 target enrollmentFebruary 14, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Young Men
Sponsor
King's College London
Enrollment
66
Locations
1
Primary Endpoint
Flow-mediated dilation
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
February 14, 2017
End Date
July 20, 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr Ana Rodriguez-Mateos

Principal investigator

King's College London

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Pulse wave velocity(Baseline and 12 weeks)
  • Blood pressure(Baseline and 12 weeks)
  • Blood measurements- Blood lipids(Baseline and 12 weeks)
  • Blood measurements(Baseline and 12 weeks)
  • Blood measurements-Electrolytes(Baseline and 12 weeks)
  • Blood measurements -Glucose(Baseline and 12 weeks)

Study Sites (1)

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