Healthy Young Men
Conditions
Keywords
Vascular function, Endothelial function, (Poly)phenols
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.
Interventions
DIETARY_SUPPLEMENTPlacebo
Identical formulation as the treatment consisting of colored maltodextrin using artificial colors.
DIETARY_SUPPLEMENTAronia full spectrum
Powdered whole fruit obtained from aronia berries (Aronia melanocarpa)
DIETARY_SUPPLEMENTAronia extract
Powdered extract obtained from aronia berries (Aronia melanocarpa)
Sponsors
Naturex-Dbs
King's College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Flow-mediated dilation | Baseline 0 and 2 hours and 12 weeks 0 and 2 hours | Change form Baseline Endothelial function at 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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-Electrolytes | Baseline and 12 weeks | Urea, Creatinine, uric acid |
| Blood measurements -Glucose | Baseline and 12 weeks | — |
| Blood measurements | Baseline and 12 weeks | Haematology (White blood cell count, red blood cell count, Haemoglobin, hematocrit, platelets, neutrophils, lymphocytes, monocytes, eosinophils, basophils, reticulocytes, eosinophils |
Other
| Measure | Time frame | Description |
|---|---|---|
| Plasma aronia berry (poly)phenol metabolites | Baseline 0 and 2 hours and 12 weeks 0 and 2 hours | Measured by liquid chromotography- mass spectrometry (LC/MS) 0 and 2 hours postconsumption |
| Microbiome analysis | Baseline and 12 weeks | Stool sample collection (Umnigene gut collection kit) |
Countries
United Kingdom
Outcome results
None listed