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NCT03824041 · ClinicalTrials.gov registry record · NA
Effects of Aronia Berries on Vascular Endothelial Function and the Gut Microbiota in Middle-Aged/Older Adults
A NA study of Aging and Endothelial Dysfunction, sponsored by Colorado State University.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT03824041 is a NA study of Aging and Endothelial Dysfunction that has completed, run by Colorado State University. The registered enrollment target is 24 participants, below the 2,195-participant average among 262 other Aging trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03824041, a NA study of Aging and Endothelial Dysfunction, has completed, sponsored by Colorado State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Aronia full spectrum - half dose
- DIETARY_SUPPLEMENT Aronia full spectrum - full dose
Study Locations (1)
Colorado
- Department of Food Science and Human Nutrition, Colorado State University - Fort Collins
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2019-02-11 |
| Est. Completion | 2021-07-26 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03824041
The ClinicalTrials.gov registry entry for NCT03824041 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,195-participant average among 262 other Aging trials with a reported enrollment target (99% lower). The listed sponsor is Colorado State University, which has 94 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Aging appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03824041 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT03824041 about?
NCT03824041 is a clinical study titled "Effects of Aronia Berries on Vascular Endothelial Function and the Gut Microbiota in Middle-Aged/Older Adults". 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...
What is the current status of trial NCT03824041?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2019-02-11. Estimated completion is 2021-07-26.
What conditions does trial NCT03824041 study?
This clinical trial studies the following conditions: Aging, Endothelial Dysfunction.
What interventions are being tested in trial NCT03824041?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Aronia full spectrum - half dose (DIETARY_SUPPLEMENT), Aronia full spectrum - full dose (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT03824041?
This trial is sponsored by Colorado State University, which has 94 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03824041 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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