Healthy, Prehypertension
Conditions
Keywords
(Poly)phenols, Aronia berry, Blood pressure, Vascular function
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
Identical formulation as the treatment consisting of colored maltodextrin using artificial colors.
DIETARY_SUPPLEMENTAronia extract
Powdered extract obtained from aronia berries (Aronia melanocarpa).
Sponsors
Naturex-Dbs
King's College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline ambulatory blood pressure after 12-week consumption | 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
| Measure | Time frame | Description |
|---|---|---|
| Office blood pressure | Baseline 0 and 2 hours and 12 weeks 0 and 2 hours | Determine the effect of the Aronia extract vs Placebo on office systolic and diastolic blood pressure, at 12 weeks post consumption |
| Heart rate | Baseline 0 and 2 hours and 12 weeks 0 and 2 hours | Determine the effect of the Aronia extract vs Placebo on heart rate, at 12 weeks post consumption |
| Flow-mediated dilation | Baseline 0 and 2 hours and 12 weeks 0 and 2 hours | Determine the effect of the Aronia extract vs Placebo on flow-mediated dilation at 12 weeks post consumption |
| Blood flow velocity | Baseline 0 and 2 hours and 12 weeks 0 and 2 hours | Determine the effect of the Aronia extract vs Placebo on blood flow velocity at 12 weeks post consumption |
| Pulse wave velocity (PWV) | Baseline 0 and 2 hours and 12 weeks 0 and 2 hours | Determine the effect of the Aronia extract vs Placebo on pulse wave velocity (PWV) using a Sphygmocor device, at 12 weeks post consumption |
| Number of volunteers with treatment-related adverse events | Baseline and 12 weeks | The number of volunteers with treatment-related adverse events will be assessed by questionnaires and interviews. |
| 24-hour heart rate | Baseline and 12 weeks | Determine the effect of the Aronia extract vs Placebo on 24-hour heart rate, using a monitor, at 12 weeks post consumption |
| Augmentation Index (AIx) | Baseline 0 and 2 hours and 12 weeks 0 and 2 hours | Determine the effect of the Aronia extract vs Placebo on augmentation Index (AIx) using a Sphygmocor device, at 12 weeks post consumption |
| Blood lipids | Baseline and 12 weeks | Determine the effect of the Aronia extract vs Placebo on blood lipids (Total, HDL and LDL cholesterol, triglycerides), at 12 weeks post consumption |
| Blood cortisol | Baseline and 12 weeks | Determine the effect of the Aronia extract vs Placebo on blood cortisol levels, at 12 weeks post consumption |
Other
| Measure | Time frame | Description |
|---|---|---|
| Plasma aronia berry (poly)phenol metabolites | 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 at day 1 (baseline) and after 12 weeks. |
| Microbiome analysis | Baseline and 12 weeks | Stool sample collection (Omnigene gut collection kit) |
Countries
United Kingdom
Outcome results
None listed