Aronia Berry Consumption on Blood Pressure

King's College London102 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

102

Conditions

Prehypertension Healthy

Interventions

PlaceboDIETARY_SUPPLEMENT

Identical formulation as the treatment consisting of colored maltodextrin using artificial colors.

Aronia extractDIETARY_SUPPLEMENT

Powdered extract obtained from aronia berries (Aronia melanocarpa).

Eligibility

Sex: ALLMin age: 40 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

Department of Life Sciences and Medecine

London, Central London, United Kingdom

King's College London

London, England, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: Baseline and 12 weeks

Secondary Outcomes

Office blood pressure

Determine the effect of the Aronia extract vs Placebo on office systolic and diastolic blood pressure, at 12 weeks post consumption