Acetate for Vasodilation

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Vasodilation+2 MoreCalcium Acetate Oral Solution - Drug
Eligibility
18+
All Sexes
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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.

Eligible Conditions
  • Aging
  • Vasodilation
  • Vascular Stiffness

Treatment Effectiveness

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks

12 weeks
% of prescribed amount of drug that is consumed
Change in 24-hour ambulatory blood pressure
Change in Brachial Artery Flow-Mediated Dilation
Change in Carotid-Femoral Pulse Wave Velocity (CFPWV)
Change in Casual (seated, resting) systolic blood pressure
Change in Endothelial Cell Markers of Oxidative Stress
Change in gut microbiome composition
Change in serum acetate
Incidence of enrolled subjects dropping out of the study due to adverse events
Week 12
Adherence
Tolerability
Baseline, 12 weeks
24-hour ambulatory blood pressure
Carotid-Femoral Pulse Wave Velocity (CFPWV)
Casual (seated, resting) systolic blood pressure
Change in Suppression of Brachial Artery Flow-Mediated Dilation by Oxidative Stress
Endothelial Cell Markers of Oxidative Stress
Gut microbiome composition
Suppression of Brachial Artery Flow-Mediated Dilation by Oxidative Stress
Week 12
Serum acetate

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Acetate
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

66 Total Participants · 2 Treatment Groups

Primary Treatment: Acetate · Has Placebo Group · Phase 2

Acetate
Drug
Experimental Group · 1 Intervention: Calcium Acetate Oral Solution · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Calcium Carbonate Oral Suspension · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,595 Previous Clinical Trials
1,927,302 Total Patients Enrolled
Vienna Brunt, PhDPrincipal InvestigatorUniversity of Colorado - Anschutz Medical Campus

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

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