Aronia Berry Consumption on Blood Pressure

NCT ID: NCT03434574

Last Updated: 2019-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-20
• Study Completion Date: 2019-09-12

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.

Conditions

Prehypertension; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Formulation containing inert artificially colored maltodextrin, once daily, in a 1-hard capsule regimen (500 mg)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Aronia extract

Formulation of an aronia extract ingredient in a 1-hard capsule regimen (500 mg)

Group Type: ACTIVE_COMPARATOR

Aronia extract

Intervention Type: DIETARY_SUPPLEMENT

Powdered extract obtained from aronia berries (Aronia melanocarpa).

Interventions

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Aronia extract

Powdered extract obtained from aronia berries (Aronia melanocarpa).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Naturex-Dbs

INDUSTRY

Sponsor Role: collaborator

King's College London

OTHER

Sponsor Role: lead

Responsible Party

Dr Ana Rodriguez-Mateos

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Life Sciences and Medecine

London, Central London, United Kingdom

King's College London

London, England, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 36228567 (View on PubMed)

Other Identifiers

Aronia BP

Identifier Type: -

Identifier Source: org_study_id