Clinical Trials Directory

Trials / Completed

CompletedNCT03824041

Effects of Aronia Berries on Vascular Endothelial Function and the Gut Microbiota in Middle-Aged/Older Adults

Aronia Berry Supplementation for Improving Vascular Endothelial Dysfunction and Modulating the Gut Microbiota in Middle-Aged/Older Adults

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
24 (actual)
Sponsor
Colorado State University · Academic / Other
Sex
All
Age
45 Years – 75 Years
Healthy volunteers
Accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTAronia full spectrum - half dosePowdered whole fruit obtained from aronia berries (Aronia melanocarpa)
DIETARY_SUPPLEMENTAronia full spectrum - full dosePowdered whole fruit obtained from aronia berries (Aronia melanocarpa)
DIETARY_SUPPLEMENTPlaceboIdentical formulation as the treatment consisting of colored maltodextrin using artificial colors.

Timeline

Start date
2019-02-11
Primary completion
2021-07-26
Completion
2021-07-26
First posted
2019-01-31
Last updated
2023-07-03

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03824041. Inclusion in this directory is not an endorsement.