Aronia Berry Consumption on Blood Pressure

Study Overview
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Brief Summary
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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 polyphenols on blood pressure and other biomarkers of cardiovascular disease risk such as endothelial function, arterial stiffness and blood lipids.

Official Title
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Evaluation of the Effect of Chokeberry (Aronia Melanocarpa) Polyphenols on Blood Pressure in Prehypertensive Healthy Men and Women

Conditions
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Prehypertension, Healthy

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Aronia extract


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy men and women aged 40-70 years old Blood pressure comprised between: SBP 120/139 mmHg or DBP 80/89 mmHg 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 and willing 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 Grade 1 hypertensive or above, 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 Chronic and acute disease Terminal renal failure and other kidney abnormalities Malignancies Abnormal heart rhythm Allergies to berries or other significant food allergy. Subjects who require treatment for hypertension at any time (e.g. statins, aspirin, blood pressure lowering drugs) Subjects who took food supplements, dietary supplement or herbal remedies within 1 month of study start 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 1 month before the study start Subjects who smoke an irregular amount of cigarettes per day Subjects who require chronic antimicrobial or antiviral treatment Subjects with unstable psychological condition Subjects with history of cancer, myocardial infarction, cerebrovascular incident Unable to swallow the capsule Pregnant, lactating or planning to become pregnant, as well as premenopausal women who do not have an adequate method of contraception 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
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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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 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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline ambulatory blood pressure after 12-week consumption | Determine the effect of the Aronia extract vs Placebo on ambulatory 24-hour systolic and diastolic blood pressure at 12 weeks post consumption, compared to the baseline. | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Office blood pressure | Determine the effect of the Aronia extract vs Placebo on office systolic and diastolic blood pressure, at 12 weeks post consumption | Baseline 0 and 2 hours and 12 weeks 0 and 2 hours | 
| Heart rate | Determine the effect of the Aronia extract vs Placebo on heart rate, at 12 weeks post consumption | Baseline 0 and 2 hours and 12 weeks 0 and 2 hours | 
| Flow-mediated dilation | Determine the effect of the Aronia extract vs Placebo on flow-mediated dilation at 12 weeks post consumption | Baseline 0 and 2 hours and 12 weeks 0 and 2 hours | 
| Blood flow velocity | Determine the effect of the Aronia extract vs Placebo on blood flow velocity at 12 weeks post consumption | Baseline 0 and 2 hours and 12 weeks 0 and 2 hours | 
| Pulse wave velocity (PWV) | Determine the effect of the Aronia extract vs Placebo on pulse wave velocity (PWV) using a Sphygmocor device, at 12 weeks post consumption | Baseline 0 and 2 hours and 12 weeks 0 and 2 hours | 
| Augmentation Index (AIx) | Determine the effect of the Aronia extract vs Placebo on augmentation Index (AIx) using a Sphygmocor device, at 12 weeks post consumption | Baseline 0 and 2 hours and 12 weeks 0 and 2 hours | 
| Blood lipids | Determine the effect of the Aronia extract vs Placebo on blood lipids (Total, HDL and LDL cholesterol, triglycerides), at 12 weeks post consumption | Baseline and 12 weeks | 
| Blood cortisol | Determine the effect of the Aronia extract vs Placebo on blood cortisol levels, at 12 weeks post consumption | Baseline and 12 weeks | 
| Number of volunteers with treatment-related adverse events | The number of volunteers with treatment-related adverse events will be assessed by questionnaires and interviews. | Baseline and 12 weeks | 
| 24-hour heart rate | Determine the effect of the Aronia extract vs Placebo on 24-hour heart rate, using a monitor, at 12 weeks post consumption | Baseline and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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(Poly)phenols, Aronia berry, Blood pressure, Vascular function