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| Name | Class |
|---|---|
| Naturex-Dbs | INDUSTRY |
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Aging is the primary risk factor for cardiovascular disease (CVD) largely due to vascular endothelial dysfunction, a major initial step in the development of atherosclerosis. Endothelial dysfunction is characterized by impaired endothelium-dependent dilation and is primarily caused by reduced nitric oxide bioavailability secondary to oxidative stress and inflammation. Interventions that improve endothelial dysfunction are important for improving endothelial function and reducing CVD risk in this high-risk population. Aronia melanocarpa, commonly known as aronia berries or chokeberries, are rich in polyphenols such as anthocyanins, proanthocyanidins, and phenolic acids. These compounds, and derivatives resulting from gut microbial and phase II metabolism, have been shown to attenuate oxidative stress and inflammation, and to improve endothelial function. Aronia berries and other berries have been shown in numerous studies to have diverse cardiometabolic health effects including modulation of endothelial function, arterial stiffness, blood pressure, oxidative stress, and inflammation. In addition, berries, dietary fiber, polyphenols have been shown to exert positive effects on the gut microbiota, which may mediate improvements in cardiovascular health. Recently, we have demonstrated that modulation of the gut microbiota is associated with improvements in vascular dysfunction. The primary goal of the currently proposed research is to assess the efficacy and dose-dependent response of an aronia full spectrum dietary supplement to improve endothelial function in middle-aged/older men and postmenopausal women. A secondary goal is to determine whether aronia full spectrum modulation of the gut microbiota is associated with improvements in endothelial function. Other functional and biochemical measures of cardiovascular health, oxidative stress, inflammation, and polyphenol metabolism will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Formulation containing inert artificially colored maltodextrin, two capsules once a day, in a 500 mg capsule regimen (total intake 1000 mg) |
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| Aronia full spectrum - half dose | Experimental | Formulation containing 50% Aronia full spectrum and 50% placebo, two capsules once a day, in a 500 mg capsule regimen (total intake 1000 mg) |
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| Aronia full spectrum - full dose | Experimental | Formulation of 100% Aronia full spectrum, two capsules once a day, in a 500 mg capsule regimen (total intake 1000 mg) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aronia full spectrum - half dose | Dietary Supplement | Powdered whole fruit obtained from aronia berries (Aronia melanocarpa) |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline reactive hyperemia index (RHI) after 6 weeks consumption | Determine the effects on RHI measured by EndoPAT | Baseline and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiota analysis | Determine the effects on stool sample microbial populations | Baseline and 6 weeks |
| Blood pressure | Determine the effects on brachial and aortic blood pressure measured by SphygmoCor |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma polyphenol metabolites | Determine the effects on plasma polyphenol metabolites | Baseline and 6 weeks |
| Fecal polyphenol metabolites | Determine the effects on fecal polyphenol metabolites |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah A Johnson, PhD, RDN | Department of Food Science and Human Nutrition, Colorado State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Food Science and Human Nutrition, Colorado State University | Fort Collins | Colorado | 80523-1571 | United States |
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| Aronia full spectrum - full dose | Dietary Supplement | Powdered whole fruit obtained from aronia berries (Aronia melanocarpa) |
|
| Placebo | Dietary Supplement | Identical formulation as the treatment consisting of colored maltodextrin using artificial colors. |
|
| Baseline and 6 weeks |
| Augmentation index | Determine the effects on augmentation index measured by SphygmoCor | Baseline and 6 weeks |
| Gastrointestinal health | Determine the effects on gastrointestinal health using a validated questionnaire | Baseline and 6 weeks |
| Pulse wave velocity | Determine the effects on aortic arterial stiffness measured by SphygmoCor | Baseline and 6 weeks |
| Blood lipids | Determine the effects on blood lipid profiles (total cholesterol, HDL, LDL, triglycerides) | Baseline and 6 weeks |
| Blood hemoglobin A1c | Determine the effects on Hemoglobin A1c | Baseline and 6 weeks |
| Blood oxidized LDL | Determine the effects on oxidized LDL | Baseline and 6 weeks |
| Blood ICAM | Determine the effects on ICAM | Baseline and 6 weeks |
| Blood VCAM | Determine the effects on VCAM | Baseline and 6 weeks |
| Baseline and 6 weeks |
| Urine polyphenol metabolites | Determine the effects on urine polyphenol metabolites | Baseline and 6 weeks |