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Aronia Berry Consumption on Vascular Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03041961
Recruitment Status : Completed
First Posted : February 3, 2017
Last Update Posted : July 5, 2019
Sponsor:
Collaborator:
Naturex-Dbs
Information provided by (Responsible Party):
Dr Ana Rodriguez-Mateos, King's College London

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.


Condition or disease Intervention/treatment Phase
Healthy Young Men Dietary Supplement: Placebo Dietary Supplement: Aronia full spectrum Dietary Supplement: Aronia extract Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effects of Aronia Berry (Chokeberry) Extract on Vascular Function in Healthy Men: a 3 Month Randomized Controlled Trial.
Actual Study Start Date : February 14, 2017
Actual Primary Completion Date : July 20, 2017
Actual Study Completion Date : July 20, 2017

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 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)

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)




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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)



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041961


Locations
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United Kingdom
Department of Life Sciences and Medecine
London, Central London, United Kingdom, SE1 9NH
Sponsors and Collaborators
King's College London
Naturex-Dbs
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Ana Rodriguez-Mateos, Principal investigator, King's College London
ClinicalTrials.gov Identifier: NCT03041961    
Other Study ID Numbers: Aronia FMD
First Posted: February 3, 2017    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Ana Rodriguez-Mateos, King's College London:
Vascular function
Endothelial function
(Poly)phenols