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| Name | Class |
|---|---|
| Naturex-Dbs | INDUSTRY |
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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 polyphenols on blood pressure and other biomarkers of cardiovascular disease risk such as endothelial function, arterial stiffness and blood lipids.
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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 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline ambulatory blood pressure after 12-week consumption | Determine the effect of the Aronia extract vs Placebo on ambulatory 24-hour systolic and diastolic blood pressure at 12 weeks post consumption, compared to the baseline. | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Office blood pressure | Determine the effect of the Aronia extract vs Placebo on office systolic and diastolic blood pressure, at 12 weeks post consumption | Baseline 0 and 2 hours and 12 weeks 0 and 2 hours |
| Heart rate |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma aronia berry (poly)phenol metabolites | Measured by liquid chromotography- mass spectrometry (LC/MS) 0 and 2 hours postconsumption at day 1 (baseline) and after 12 weeks. | 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 | ||
| King's College London |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36228567 | Derived | Le Sayec M, Xu Y, Laiola M, Gallego FA, Katsikioti D, Durbidge C, Kivisild U, Armes S, Lecomte M, Fanca-Berthon P, Fromentin E, Plaza Onate F, Cruickshank JK, Rodriguez-Mateos A. The effects of Aronia berry (poly)phenol supplementation on arterial function and the gut microbiome in middle aged men and women: Results from a randomized controlled trial. Clin Nutr. 2022 Nov;41(11):2549-2561. doi: 10.1016/j.clnu.2022.08.024. Epub 2022 Sep 6. |
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| ID | Term |
|---|---|
| D058246 | Prehypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Aronia extract | Dietary Supplement | Powdered extract obtained from aronia berries (Aronia melanocarpa). |
|
Determine the effect of the Aronia extract vs Placebo on heart rate, at 12 weeks post consumption
| Baseline 0 and 2 hours and 12 weeks 0 and 2 hours |
| Flow-mediated dilation | Determine the effect of the Aronia extract vs Placebo on flow-mediated dilation at 12 weeks post consumption | Baseline 0 and 2 hours and 12 weeks 0 and 2 hours |
| Blood flow velocity | Determine the effect of the Aronia extract vs Placebo on blood flow velocity at 12 weeks post consumption | Baseline 0 and 2 hours and 12 weeks 0 and 2 hours |
| Pulse wave velocity (PWV) | Determine the effect of the Aronia extract vs Placebo on pulse wave velocity (PWV) using a Sphygmocor device, at 12 weeks post consumption | Baseline 0 and 2 hours and 12 weeks 0 and 2 hours |
| Augmentation Index (AIx) | Determine the effect of the Aronia extract vs Placebo on augmentation Index (AIx) using a Sphygmocor device, at 12 weeks post consumption | Baseline 0 and 2 hours and 12 weeks 0 and 2 hours |
| Blood lipids | Determine the effect of the Aronia extract vs Placebo on blood lipids (Total, HDL and LDL cholesterol, triglycerides), at 12 weeks post consumption | Baseline and 12 weeks |
| Blood cortisol | Determine the effect of the Aronia extract vs Placebo on blood cortisol levels, at 12 weeks post consumption | Baseline and 12 weeks |
| Number of volunteers with treatment-related adverse events | The number of volunteers with treatment-related adverse events will be assessed by questionnaires and interviews. | Baseline and 12 weeks |
| 24-hour heart rate | Determine the effect of the Aronia extract vs Placebo on 24-hour heart rate, using a monitor, at 12 weeks post consumption | Baseline and 12 weeks |
Stool sample collection (Omnigene gut collection kit)
| Baseline and 12 weeks |
| London |
| England |
| SE1 9NH |
| United Kingdom |