Status:
RECRUITING
Acetate and Age-associated Arterial Dysfunction
Lead Sponsor:
University of Colorado, Denver
Conditions:
Aging
Vascular Stiffness
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
This is a randomized, double-blind, placebo-controlled, parallel design clinical trial to assess the efficacy of 12 weeks of oral acetate supplementation for improving arterial function in late middle...
Eligibility Criteria
Inclusion
- Able to provide informed consent;
- Age 50+ years;
- Serum phosphorus levels \>= 2.5 mg/dl at screening;
- Habitual dietary fiber intake \<30 g/day for men or \<21 g/day for women, based on Block Fiber Screener conducted at screening;
- Weight-stable in the 3 months prior to enrollment (self-report);
- Willing to abstain from dietary supplements for 48 hours and from alcohol, tobacco, and cannabis products for 24 hours before all visits;
Exclusion
- History of current serious, chronic clinical disease, e.g., cardiovascular disease, diabetes, liver disease, Alzheimer's disease and related dementias, cancer;
- Major changes in health in the past 3 months, e.g., hospitalizations, major surgeries, significant changes in medications;
- Currently taking calcium acetate or any other calcium supplementation;
- Screening FMDba \> 8%;
- Body mass index \> 40 kg/m\^2 at screening;
- Regular vigorous/aerobic endurance \>4 bouts/week for \>30 min/bout at a workload of \>6 METS;
- Any apparent dependence on or abuse of alcohol, tobacco, and cannabis products;
- Pregnancy, breast-feeding, or plans to become pregnant during the duration of the study;
- Any finding on the medical history, physical exam, or standard clinical blood labs that, in the opinion of the physician of record, would put the subject at increased risk with calcium supplementation.
Key Trial Info
Start Date :
September 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2025
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT05424263
Start Date
September 29 2022
End Date
September 1 2025
Last Update
March 15 2024
Active Locations (1)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045