Aronia Berry Consumption on Vascular Function

Healthy Young Men Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03041961
• Other study ID #: Aronia FMD
• Status: Completed
• Phase: N/A
• Start date: February 14, 2017
• Est. completion date: July 20, 2017

Study information

• Verified date: July 2019
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 20, 2017
• Est. primary completion date: July 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Young Men

Intervention

Dietary Supplement:
• Placebo
Identical formulation as the treatment consisting of colored maltodextrin using artificial colors.
• Aronia full spectrum
Powdered whole fruit obtained from aronia berries (Aronia melanocarpa)
• Aronia extract
Powdered extract obtained from aronia berries (Aronia melanocarpa)

Locations

Country	Name	City	State
United Kingdom	Department of Life Sciences and Medecine	London	Central London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	Naturex-Dbs

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma aronia berry (poly)phenol metabolites	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
Other	Microbiome analysis	Stool sample collection (Umnigene gut collection kit)	Baseline and 12 weeks
Primary	Flow-mediated dilation	Change form Baseline Endothelial function at 12 weeks	Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Secondary	Pulse wave velocity	Measured by SphygmoCor 0 and 2 hours postconsumption	Baseline and 12 weeks
Secondary	Blood pressure	Automatical measurements 0 and 2 hours postconsumption	Baseline and 12 weeks
Secondary	Blood measurements- Blood lipids	Cholesterol, HDL, LDL, triglycerides	Baseline and 12 weeks
Secondary	Blood measurements	Haematology (White blood cell count, red blood cell count, Haemoglobin, hematocrit, platelets, neutrophils, lymphocytes, monocytes, eosinophils, basophils, reticulocytes, eosinophils	Baseline and 12 weeks
Secondary	Blood measurements-Electrolytes	Urea, Creatinine, uric acid	Baseline and 12 weeks
Secondary	Blood measurements	Liver values (bilirubin, lactate dehydrogenase, aspartate aminotransferase, gamma-glutamyltranspeptidase, total protein, albumine, alkaline phosphatase)	Baseline and 12 weeks
Secondary	Blood measurements -Glucose		Baseline and 12 weeks