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| Name | Class |
|---|---|
| Naturex-Dbs | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Formulation containing inert artificially colored maltodextrin, once daily, in a 1-hard capsule regimen (500 mg) |
|
| Aronia full spectrum | Active Comparator | Formulation of an aronia full spectrum ingredient in a 1-hard capsule regimen (500 mg) |
|
| Aronia extract | Active Comparator | Formulation of an aronia extract ingredient in a 1-hard capsule regimen (500 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Identical formulation as the treatment consisting of colored maltodextrin using artificial colors. |
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| Measure | Description | Time Frame |
|---|---|---|
| Flow-mediated dilation | Change form Baseline Endothelial function at 12 weeks | Baseline 0 and 2 hours and 12 weeks 0 and 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pulse wave velocity | Measured by SphygmoCor 0 and 2 hours postconsumption | Baseline and 12 weeks |
| Blood pressure | Automatical measurements 0 and 2 hours postconsumption |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma aronia berry (poly)phenol metabolites | Measured by liquid chromotography- mass spectrometry (LC/MS) 0 and 2 hours postconsumption | Baseline 0 and 2 hours and 12 weeks 0 and 2 hours |
| Microbiome analysis |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Life Sciences and Medecine | London | Central London | SE1 9NH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31152545 | Derived | 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. |
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| Aronia full spectrum | Dietary Supplement | Powdered whole fruit obtained from aronia berries (Aronia melanocarpa) |
|
| Aronia extract | Dietary Supplement | Powdered extract obtained from aronia berries (Aronia melanocarpa) |
|
| Baseline and 12 weeks |
| Blood measurements- Blood lipids | Cholesterol, HDL, LDL, triglycerides | Baseline and 12 weeks |
| Blood measurements | Haematology (White blood cell count, red blood cell count, Haemoglobin, hematocrit, platelets, neutrophils, lymphocytes, monocytes, eosinophils, basophils, reticulocytes, eosinophils | Baseline and 12 weeks |
| Blood measurements-Electrolytes | Urea, Creatinine, uric acid | Baseline and 12 weeks |
| Blood measurements | Liver values (bilirubin, lactate dehydrogenase, aspartate aminotransferase, gamma-glutamyltranspeptidase, total protein, albumine, alkaline phosphatase) | Baseline and 12 weeks |
| Blood measurements -Glucose | Baseline and 12 weeks |
Stool sample collection (Umnigene gut collection kit)
| Baseline and 12 weeks |