Aronia Berry Consumption on Blood Pressure

NCT03434574 | Completed

• 1 other identifier: Aronia BP
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

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

Keywords

(Poly)phenols; Aronia berry; Blood pressure; Vascular function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Office blood pressure

  Baseline 0 and 2 hours and 12 weeks 0 and 2 hours

• Heart rate

  Baseline 0 and 2 hours and 12 weeks 0 and 2 hours

• Flow-mediated dilation

  Baseline 0 and 2 hours and 12 weeks 0 and 2 hours

• Blood flow velocity

  Baseline 0 and 2 hours and 12 weeks 0 and 2 hours

• Pulse wave velocity (PWV)

  Baseline 0 and 2 hours and 12 weeks 0 and 2 hours

Other Outcomes (2)

• Plasma aronia berry (poly)phenol metabolites

  Baseline 0 and 2 hours and 12 weeks 0 and 2 hours

• Microbiome analysis

  Baseline and 12 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Aronia extract

ACTIVE COMPARATOR

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

Dietary Supplement: Aronia extract

Interventions

Placebo DIETARY_SUPPLEMENT

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

Placebo

Aronia extract DIETARY_SUPPLEMENT

Powdered extract obtained from aronia berries (Aronia melanocarpa).

Aronia extract

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College London: lead
• Naturex-Dbs: collaborator

Study Sites (2)

Department of Life Sciences and Medecine

London, Central London, SE1 9NH, United Kingdom

Location

King's College London

London, England, SE1 9NH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 36228567 DERIVED

MeSH Terms

Conditions

Prehypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: February 15, 2018
• Study Start: February 20, 2018
• Primary Completion: September 12, 2019
• Study Completion: September 12, 2019
• Last Updated: September 23, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)