Clinical trial NCT03041961: Aronia Berry Consumption on Vascular Function
Official title: Effects of Aronia Berry (Chokeberry) Extract on Vascular Function in Healthy Men: a 3 Month Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Young Men
Keywords: Vascular function
Endothelial function
(Poly)phenols
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: Naturex-Dbs
First posted: 2017-02-03
Enrollment: 66
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Flow-mediated dilation
timeFrame: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
Secondary outcomes:
measure: Pulse wave velocity
timeFrame: Baseline and 12 weeks
measure: Blood pressure
timeFrame: Baseline and 12 weeks
measure: Blood measurements- Blood lipids
timeFrame: Baseline and 12 weeks
measure: Blood measurements
timeFrame: Baseline and 12 weeks
measure: Blood measurements-Electrolytes
timeFrame: Baseline and 12 weeks
measure: Blood measurements
timeFrame: Baseline and 12 weeks
measure: Blood measurements -Glucose
timeFrame: Baseline and 12 weeks
Other outcomes:
measure: Plasma aronia berry (poly)phenol metabolites
timeFrame: Baseline 0 and 2 hours and 12 weeks 0 and 2 hours
measure: Microbiome analysis
timeFrame: Baseline and 12 weeks
Locations:
city: London
country: United Kingdom
facility: Department of Life Sciences and Medecine
state: Central London
Study officials:
References:
citation: 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.