Evaluation of the Effect of Chokeberry (Aronia Melanocarpa) Polyphenols on Blood Pressure in Prehypertensive Healthy Men and Women
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prehypertension
- Sponsor
- King's College London
- Enrollment
- 102
- Locations
- 2
- Primary Endpoint
- Changes from baseline ambulatory blood pressure after 12-week consumption
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Dr Ana Rodriguez-Mateos
Principal investigator
King's College London
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Changes from baseline ambulatory blood pressure after 12-week consumption
Time Frame: Baseline and 12 weeks
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.
Secondary Outcomes
- Blood lipids(Baseline and 12 weeks)
- Number of volunteers with treatment-related adverse events(Baseline and 12 weeks)
- Blood flow velocity(Baseline 0 and 2 hours and 12 weeks 0 and 2 hours)
- Pulse wave velocity (PWV)(Baseline 0 and 2 hours and 12 weeks 0 and 2 hours)
- Heart rate(Baseline 0 and 2 hours and 12 weeks 0 and 2 hours)
- Blood cortisol(Baseline and 12 weeks)
- Augmentation Index (AIx)(Baseline 0 and 2 hours and 12 weeks 0 and 2 hours)
- Office blood pressure(Baseline 0 and 2 hours and 12 weeks 0 and 2 hours)
- Flow-mediated dilation(Baseline 0 and 2 hours and 12 weeks 0 and 2 hours)
- 24-hour heart rate(Baseline and 12 weeks)