Aronia Berry Consumption on Blood Pressure

Not Applicable

Completed

• Conditions: Prehypertension; Healthy
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Aronia extract

• Registration Number: NCT03434574
• Lead Sponsor: King's College London

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-11
• Study First Submitted QC: 2018-02-09
• Study First Posted: 2018-02-15
• Study Start: 2018-02-20
• Status Verified: 2019-09
• Primary Completion: 2019-09-12
• Study Completion: 2019-09-12
• Last Update Submitted: 2019-09-20
• Last Update Posted: 2019-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Formulation containing inert artificially colored maltodextrin, once daily, in a 1-hard capsule regimen (500 mg)
Aronia extract	Aronia extract	Formulation of an aronia extract ingredient in a 1-hard capsule regimen (500 mg)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.
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
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
Blood cortisol	Baseline and 12 weeks	Determine the effect of the Aronia extract vs Placebo on blood cortisol levels, 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
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
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
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

Trial Locations

Locations (2)

Department of Life Sciences and Medecine; 🇬🇧 London, Central London, United Kingdom

King's College London; 🇬🇧 London, England, United Kingdom