Aronia Berry Consumption on Vascular Function

King's College London

Status: Completed

Conditions: Healthy Young Men

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Aronia full spectrum; Dietary Supplement: Aronia extract

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03041961

Aronia FMD

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 3 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 full spectrum

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Aronia full spectrum

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