Aronia Berry Consumption on Vascular Function

Study 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.

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

Conditions
-----------------
Healthy Young Men

Intervention / Treatment
-----------------
* Dietary Supplement: Placebo
* Dietary Supplement: Aronia full spectrum
* Dietary Supplement: Aronia extract


Participation Criteria
=================
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. 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vascular function, Endothelial function, (Poly)phenols