Aronia Berry Consumption on Blood Pressure (ABP)

September 20, 2019 updated by: Dr Ana Rodriguez-Mateos, King's College London

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Office blood pressure
Time Frame: 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
Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Heart rate
Time Frame: 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
Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Flow-mediated dilation
Time Frame: 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
Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Blood flow velocity
Time Frame: 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
Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Pulse wave velocity (PWV)
Time Frame: 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
Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Augmentation Index (AIx)
Time Frame: 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
Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Blood lipids
Time Frame: 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
Baseline and 12 weeks
Blood cortisol
Time Frame: Baseline and 12 weeks
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
Time Frame: Baseline and 12 weeks
The number of volunteers with treatment-related adverse events will be assessed by questionnaires and interviews.
Baseline and 12 weeks
24-hour heart rate
Time Frame: 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
Baseline and 12 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plasma aronia berry (poly)phenol metabolites
Time Frame: 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.
Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Microbiome analysis
Time Frame: Baseline and 12 weeks
Stool sample collection (Omnigene gut collection kit)
Baseline and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King's College London

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Naturex-Dbs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 12, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 12, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 15, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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