Aronia Berry Consumption on Blood Pressure (ABP)

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

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 Overview

• Status: Completed
• Conditions: Healthy; Prehypertension
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Aronia extract

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Central London
    • London, Central London, United Kingdom, SE1 9NH
      • Department of Life Sciences and Medecine
  • England
    • London, England, United Kingdom, SE1 9NH
      • King's College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Formulation containing inert artificially colored maltodextrin, once daily, in a 1-hard capsule regimen (500 mg)	Dietary supplement: Placebo; Identical formulation as the treatment consisting of colored maltodextrin using artificial colors.
Active Comparator: Aronia extract; Formulation of an aronia extract ingredient in a 1-hard capsule regimen (500 mg)	Dietary supplement: Aronia extract; Powdered extract obtained from aronia berries (Aronia melanocarpa).

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma aronia berry (poly)phenol metabolites	Measured by liquid chromotography- mass spectrometry (LC/MS) 0 and 2 hours postconsumption at day 1 (baseline) and after 12 weeks.	Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Microbiome analysis	Stool sample collection (Omnigene gut collection kit)	Baseline and 12 weeks

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: Naturex-Dbs

Publications and helpful links

General Publications

• Le Sayec M, Xu Y, Laiola M, Gallego FA, Katsikioti D, Durbidge C, Kivisild U, Armes S, Lecomte M, Fanca-Berthon P, Fromentin E, Plaza Onate F, Cruickshank JK, Rodriguez-Mateos A. The effects of Aronia berry (poly)phenol supplementation on arterial function and the gut microbiome in middle aged men and women: Results from a randomized controlled trial. Clin Nutr. 2022 Nov;41(11):2549-2561. doi: 10.1016/j.clnu.2022.08.024. Epub 2022 Sep 6.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2018
• Primary Completion (Actual): September 12, 2019
• Study Completion (Actual): September 12, 2019

Study Registration Dates

• First Submitted: January 11, 2018
• First Submitted That Met QC Criteria: February 9, 2018
• First Posted (Actual): February 15, 2018

Study Record Updates

• Last Update Posted (Actual): September 23, 2019
• Last Update Submitted That Met QC Criteria: September 20, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Blood pressure; Vascular function; (Poly)phenols; Aronia berry
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Prehypertension
• Other Study ID Numbers: Aronia BP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No