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NCT04530916 · ClinicalTrials.gov registry record · Phase 1
Wild Blueberries and Cardiovascular Health in Middle-aged/Older Men and Postmenopausal Women
A Phase 1 study of Hypertension and Aging, sponsored by Colorado State University.
- Active
- Registry status
- Phase 1
- Development phase
- 58
- Enrollment target
- 1
- Study location
NCT04530916: Active Phase 1 study of Hypertension and Aging, sponsored by Colorado State University.
NCT04530916 is a Phase 1 study of Hypertension and Aging that is active but no longer recruiting, run by Colorado State University. The registered enrollment target is 58 participants, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04530916, a Phase 1 study of Hypertension and Aging, is active but no longer recruiting, sponsored by Colorado State University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 58 participants
- Enrollment target
- 1
- Study location
Study Summary
Cardiovascular disease (CVD) is the leading cause of morbidity and mortality worldwide. Aging is the primary risk factor for CVD, in large part due to adverse modifications to the arteries. These modifications include vascular endothelial dysfunction and arterial stiffness. Vascular endothelial dysfunction is an initiating step in atherosclerosis, and is primarily caused by reduced nitric oxide (NO) bioavailability secondary to excessive superoxide-driven oxidative stress and inflammation. Endothelial dysfunction leads to arterial stiffness and the development of hypertension (HTN) which further increases CVD. Greater than 2/3 of the US population has elevated blood pressure or stage 1-HTN. As such, interventions that improve vascular endothelial dysfunction by increasing NO bioavailability and mitigating excessive oxidative stress and inflammation are needed. Blueberries are rich in bioactive compounds including flavonoids, phenolic acids, and pterostilbene. These compounds and their metabolites have been shown to attenuate oxidative stress and inflammation. The primary goal of this study is to assess the efficacy of blueberries to improve reduce blood pressure and improve vascular endothelial dysfunction and arterial stiffness in middle-aged/older men with elevated blood pressure or stage 1-HTN.
Primary Outcome
Endothelial function assessed as reactive hyperemia index using peripheral arterial tonometry (EndoPat)
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Blueberry Powder
- DIETARY_SUPPLEMENT Placebo Powder
Study Locations (1)
Colorado
- Food and Nutrition Clinical Research Laboratory - Fort Collins
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2020-01-01 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 1 |
What the registry record for NCT04530916 still lists
NCT04530916 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 3,507-participant average among 470 other Hypertension trials with a reported enrollment target (98% lower).
The record links to 4 conditions, with Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Blueberry Powder is the first listed.
NCT04530916 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT04530916 about?
NCT04530916 is a clinical study titled "Wild Blueberries and Cardiovascular Health in Middle-aged/Older Men and Postmenopausal Women". Cardiovascular disease (CVD) is the leading cause of morbidity and mortality worldwide. Aging is the primary risk factor for CVD, in large part due to adverse modifications to the arteries. These modifications include vascular endothelial dysfunction and arterial stiffness. Vascular endothelial dysf...
What is the current status of trial NCT04530916?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2020-01-01. Estimated completion is 2025-12-31.
What conditions does trial NCT04530916 study?
This clinical trial studies the following conditions: Hypertension, Aging, Endothelial Dysfunction, Men.
What interventions are being tested in trial NCT04530916?
The interventions under investigation include: Blueberry Powder (DIETARY_SUPPLEMENT), Placebo Powder (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04530916?
This trial is sponsored by Colorado State University, which has 94 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04530916 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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58 356th of 470 higher than 114 of 470 other Hypertension trials
participants (enrollment target), bucketed by value
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