Aronia Berry Consumption on Vascular Function

July 2, 2019 updated by: Dr Ana Rodriguez-Mateos, King's College London

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Central London
      • London, Central London, United Kingdom, SE1 9NH
        • Department of Life Sciences and Medecine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Formulation containing inert artificially colored maltodextrin, once daily, in a 1-hard capsule regimen (500 mg)
Dietary supplement: Placebo
Identical formulation as the treatment consisting of colored maltodextrin using artificial colors.
Active Comparator: Aronia extract
Formulation of an aronia extract ingredient in a 1-hard capsule regimen (500 mg)
Dietary supplement: Aronia extract
Powdered extract obtained from aronia berries (Aronia melanocarpa)
Active Comparator: Aronia full spectrum
Formulation of an aronia full spectrum ingredient in a 1-hard capsule regimen (500 mg)
Dietary supplement: Aronia full spectrum
Powdered whole fruit obtained from aronia berries (Aronia melanocarpa)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline 0 and 2 hours and 12 weeks 0 and 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulse wave velocity
Time Frame: Baseline and 12 weeks
Measured by SphygmoCor 0 and 2 hours postconsumption
Baseline and 12 weeks
Blood pressure
Time Frame: Baseline and 12 weeks
Automatical measurements 0 and 2 hours postconsumption
Baseline and 12 weeks
Blood measurements- Blood lipids
Time Frame: Baseline and 12 weeks
Cholesterol, HDL, LDL, triglycerides
Baseline and 12 weeks
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
Baseline and 12 weeks
Blood measurements-Electrolytes
Time Frame: Baseline and 12 weeks
Urea, Creatinine, uric acid
Baseline and 12 weeks
Blood measurements
Time Frame: Baseline and 12 weeks
Liver values (bilirubin, lactate dehydrogenase, aspartate aminotransferase, gamma-glutamyltranspeptidase, total protein, albumine, alkaline phosphatase)
Baseline and 12 weeks
Blood measurements -Glucose
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Microbiome analysis
Time Frame: Baseline and 12 weeks
Stool sample collection (Umnigene gut collection kit)
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Collaborators

Naturex-Dbs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2017

Primary Completion (Actual)

July 20, 2017

Study Completion (Actual)

July 20, 2017

Study Registration Dates

First Submitted

February 2, 2017

First Submitted That Met QC Criteria

February 2, 2017

First Posted (Estimate)

February 3, 2017

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 2, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Aronia FMD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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