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
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Aronia full spectrum - half dose | Powdered whole fruit obtained from aronia berries (Aronia melanocarpa) |
| DIETARY_SUPPLEMENT | Aronia full spectrum - full dose | Powdered whole fruit obtained from aronia berries (Aronia melanocarpa) |
| DIETARY_SUPPLEMENT | Placebo | Identical 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.