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Completed

NCT Number: NCT03434574

Aronia Berry Consumption on Blood Pressure

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.

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Key information

Conditions

Prehypertension Cardiovascular Diseases Healthy Vascular Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Life Sciences and Medecine, London, Central London, United Kingdom

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Dietary Supplement

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

Aronia extract

Dietary Supplement

Powdered extract obtained from aronia berries (Aronia melanocarpa).

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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.

  10. 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

Other outcomes

  1. 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.

  2. Microbiome analysis

    Time frame: Baseline and 12 weeks

    Stool sample collection (Omnigene gut collection kit)

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • Naturex-Dbs

Registry information

Official study title

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

Acronym: ABP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 15, 2018
Registry last updated
Sep 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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