Aronia Berry Consumption on Vascular Function

Not Applicable

Completed

• Conditions: Healthy Young Men
• Interventions: Dietary Supplement: Aronia extract; Dietary Supplement: Aronia full spectrum; Dietary Supplement: Placebo

• Registration Number: NCT03041961
• Lead Sponsor: King's College London

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-02-02
• Study First Posted: 2017-02-03
• Study Start: 2017-02-14
• Primary Completion: 2017-07-20
• Study Completion: 2017-07-20
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aronia extract	Aronia extract	Formulation of an aronia extract ingredient in a 1-hard capsule regimen (500 mg)
Aronia full spectrum	Aronia full spectrum	Formulation of an aronia full spectrum ingredient in a 1-hard capsule regimen (500 mg)
Placebo	Placebo	Formulation containing inert artificially colored maltodextrin, once daily, in a 1-hard capsule regimen (500 mg)

Primary Outcome Measures

Name	Time	Method
Flow-mediated dilation	Baseline 0 and 2 hours and 12 weeks 0 and 2 hours	Change form Baseline Endothelial function at 12 weeks

Secondary Outcome Measures

Name	Time	Method
Pulse wave velocity	Baseline and 12 weeks	Measured by SphygmoCor 0 and 2 hours postconsumption
Blood pressure	Baseline and 12 weeks	Automatical measurements 0 and 2 hours postconsumption
Blood measurements- Blood lipids	Baseline and 12 weeks	Cholesterol, HDL, LDL, triglycerides
Blood measurements	Baseline and 12 weeks	Liver values (bilirubin, lactate dehydrogenase, aspartate aminotransferase, gamma-glutamyltranspeptidase, total protein, albumine, alkaline phosphatase)
Blood measurements-Electrolytes	Baseline and 12 weeks	Urea, Creatinine, uric acid
Blood measurements -Glucose	Baseline and 12 weeks

Trial Locations

Locations (1)

Department of Life Sciences and Medecine; 🇬🇧 London, Central London, United Kingdom