Aronia Berry Consumption on Vascular Function

NCT03041961 | Completed

• 1 other identifier: Aronia FMD
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

There is an increasing interest in the effects of various food derived polyphenols on vascular function. Arguably the most well-established vascular benefits are attributed to flavanols from cocoa beans and this has been supported by a successful health claim through the European Food Safely Authority in 2012. Berry fruits are another rich source of polyphenols that have vasoactive properties, and there is a growing body of research exploring these effects in various berries (blueberries, cranberries, strawberries) and other fruit products with similar polyphenol composition. A key (poly)phenol in berries and other fruits believed to provide much of the benefit is anthocyanins. When given as an isolated extract, 320 mg anthocyanins have been found to improve blood vessel function both acutely and in response to chronic consumption over 12 weeks. 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 extracts of differing polyphenol dose on vascular endothelial function.

Conditions

Healthy Young Men

Keywords

Vascular function; Endothelial function; (Poly)phenols

Outcome Measures

Primary Outcomes (1)

• Flow-mediated dilation

  Change form Baseline Endothelial function at 12 weeks

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

Secondary Outcomes (7)

• Pulse wave velocity

  Baseline and 12 weeks

• Blood pressure

  Baseline and 12 weeks

• Blood measurements- Blood lipids

  Baseline and 12 weeks

• Blood measurements

  Baseline and 12 weeks

• Blood measurements-Electrolytes

  Baseline and 12 weeks

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 (3)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Aronia full spectrum

ACTIVE COMPARATOR

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

Dietary Supplement: Aronia full spectrum

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 full spectrum DIETARY_SUPPLEMENT

Powdered whole fruit obtained from aronia berries (Aronia melanocarpa)

Aronia full spectrum

Aronia extract DIETARY_SUPPLEMENT

Powdered extract obtained from aronia berries (Aronia melanocarpa)

Aronia extract

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy men aged 18-45 years old
• 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 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
• Hypertensive, 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
• Terminal renal failure
• Malignancies
• Abnormal heart rhythm (lower or higher than 60-100 bpm)
• Allergies to berries or other significant food allergy.
• Subjects under medication or on vitamin/dietary supplements.
• 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 one month before the study start
• Subjects who smoke an irregular amount of cigarettes per day
• Unable to swallow the capsule
• 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.

Sponsors & Collaborators

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

Study Sites (1)

Department of Life Sciences and Medecine

London, Central London, SE1 9NH, United Kingdom

Location

Related Publications (1)

• Istas G, Wood E, Le Sayec M, Rawlings C, Yoon J, Dandavate V, Cera D, Rampelli S, Costabile A, Fromentin E, Rodriguez-Mateos A. Effects of aronia berry (poly)phenols on vascular function and gut microbiota: a double-blind randomized controlled trial in adult men. Am J Clin Nutr. 2019 Aug 1;110(2):316-329. doi: 10.1093/ajcn/nqz075.

  PMID: 31152545 DERIVED

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: February 2, 2017
• First Posted: February 3, 2017
• Study Start: February 14, 2017
• Primary Completion: July 20, 2017
• Study Completion: July 20, 2017
• Last Updated: July 5, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)