Department of Food Science and Human Nutrition, Colorado State University
Fort Collins, Colorado, 80523-1571, United States
NCT Number: NCT03824041
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.
Looking for future studies?
Notify Me45 year–75 year
All sexes
Interventional
Not applicable
Fort Collins, Colorado, 80523-1571, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Powdered whole fruit obtained from aronia berries (Aronia melanocarpa)
Powdered whole fruit obtained from aronia berries (Aronia melanocarpa)
Identical formulation as the treatment consisting of colored maltodextrin using artificial colors.
Time frame: Baseline and 6 weeks
Determine the effects on RHI measured by EndoPAT
Time frame: Baseline and 6 weeks
Determine the effects on stool sample microbial populations
Time frame: Baseline and 6 weeks
Determine the effects on brachial and aortic blood pressure measured by SphygmoCor
Time frame: Baseline and 6 weeks
Determine the effects on augmentation index measured by SphygmoCor
Time frame: Baseline and 6 weeks
Determine the effects on gastrointestinal health using a validated questionnaire
Time frame: Baseline and 6 weeks
Determine the effects on aortic arterial stiffness measured by SphygmoCor
Time frame: Baseline and 6 weeks
Determine the effects on blood lipid profiles (total cholesterol, HDL, LDL, triglycerides)
Time frame: Baseline and 6 weeks
Determine the effects on Hemoglobin A1c
Time frame: Baseline and 6 weeks
Determine the effects on oxidized LDL
Time frame: Baseline and 6 weeks
Determine the effects on ICAM
Time frame: Baseline and 6 weeks
Determine the effects on VCAM
Time frame: Baseline and 6 weeks
Determine the effects on plasma polyphenol metabolites
Time frame: Baseline and 6 weeks
Determine the effects on fecal polyphenol metabolites
Time frame: Baseline and 6 weeks
Determine the effects on urine polyphenol metabolites
Colorado State University
Other
Aronia Berry Supplementation for Improving Vascular Endothelial Dysfunction and Modulating the Gut Microbiota in Middle-Aged/Older Adults
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