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NCT05424263 · ClinicalTrials.gov registry record · Phase 2
Acetate and Age-associated Arterial Dysfunction
A Phase 2 study of Aging and Vascular Stiffness, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
- 1
- Study location
NCT05424263 is a Phase 2 study of Aging and Vascular Stiffness that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 66 participants, below the 2,194-participant average among 262 other Aging trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05424263, a Phase 2 study of Aging and Vascular Stiffness, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
- 1
- Study location
Study Summary
Cardiovascular diseases are the leading cause of morbidity and mortality and contribute most to healthcare costs in the U.S. Age is the strongest cardiovascular disease risk factor, with \>90% of all deaths from cardiovascular disease occurring in adults \>50 years old. The age-associated increased risk of cardiovascular disease is due, in large part, to the development of arterial dysfunction, including endothelial dysfunction and stiffening of the large elastic arteries. Therefore, novel, effective interventions that improve arterial function will have a large public health impact by decreasing the risk of cardiovascular diseases. The short-chain fatty acid acetate is endogenously produced by the gut microbiome from fermentation of dietary soluble fiber. High-fiber diets reduce risk of cardiovascular diseases, but unfortunately, a low percentage of Americans meet guidelines for adequate dietary fiber intake and, despite nationwide efforts to improve this, trends in fiber intake have not improved over the last 20+ years. Thus, directly supplementing acetate may be a more practical and feasible intervention for effectively improving arterial function in older adults and reducing the risk of cardiovascular diseases. The investigators will conduct a study to determine the efficacy of 12 weeks of oral supplementation with acetate for improving arterial function in late middle-aged and older (50+ years) adults. They will also assess the safety and tolerability of acetate supplementation in these adults and perform innovative mechanistic analyses to determine how acetate supplementation improves arterial function. The investigators hypothesize that oral acetate supplementation will improve arterial function by decreasing oxidative stress and increasing nitric oxide bioavailability, and also hypothesize that acetate supplementation will be safe and promote high rates of adherence.
Conditions Studied
Interventions
- DRUG Calcium Acetate Oral Solution
- DRUG Calcium Carbonate Oral Suspension
Study Locations (1)
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2022-09-29 |
| Est. Completion | 2025-09-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05424263
The ClinicalTrials.gov registry entry for NCT05424263 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,194-participant average among 262 other Aging trials with a reported enrollment target (97% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Aging appearing as the primary indexed condition, and to 2 interventions - of which Calcium Acetate Oral Solution is the first listed.
NCT05424263 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.
Frequently Asked Questions
What is clinical trial NCT05424263 about?
NCT05424263 is a clinical study titled "Acetate and Age-associated Arterial Dysfunction". Cardiovascular diseases are the leading cause of morbidity and mortality and contribute most to healthcare costs in the U.S. Age is the strongest cardiovascular disease risk factor, with \>90% of all deaths from cardiovascular disease occurring in adults \>50 years old. The age-associated increased ...
What is the current status of trial NCT05424263?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2022-09-29. Estimated completion is 2025-09-01.
What conditions does trial NCT05424263 study?
This clinical trial studies the following conditions: Aging, Vascular Stiffness, Vascular Dilation.
What interventions are being tested in trial NCT05424263?
The interventions under investigation include: Calcium Acetate Oral Solution (DRUG), Calcium Carbonate Oral Suspension (DRUG).
Who is sponsoring clinical trial NCT05424263?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05424263 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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