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Aronia Berry Consumption on Blood Pressure (ABP)

K

King's College London

Status

Completed

Conditions

Healthy
Prehypertension

Treatments

Dietary Supplement: Aronia extract
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03434574
Aronia BP

Details and patient eligibility

About

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.

Enrollment

102 patients

Sex

All

Ages

40 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

102 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Formulation containing inert artificially colored maltodextrin, once daily, in a 1-hard capsule regimen (500 mg)
Treatment:
Dietary Supplement: Placebo
Aronia extract
Active Comparator group
Description:
Formulation of an aronia extract ingredient in a 1-hard capsule regimen (500 mg)
Treatment:
Dietary Supplement: Aronia extract

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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